Trial Outcomes & Findings for Teva Asthma Predictive Analytics Study (NCT NCT04997304)
NCT ID: NCT04997304
Last Updated: 2025-07-08
Results Overview
This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
up to 1 year
Results posted on
2025-07-08
Participant Flow
Participant milestones
| Measure |
AirDuo and ProAir
This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.
AirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
ProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
AirDuo and ProAir
This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.
AirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
ProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
Baseline Characteristics
Teva Asthma Predictive Analytics Study
Baseline characteristics by cohort
| Measure |
AirDuo and ProAir
n=100 Participants
This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.
AirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
ProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
|
|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 14.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the ProAir® Digihaler™.
This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up.
Outcome measures
| Measure |
ProAir® Digihaler
n=100 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
|
|---|---|
|
Mean Number of Daily Doses of ProAir® Digihaler™
|
0.55 doses per day
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™.
This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses for a given participant divided by their number of days of follow-up.
Outcome measures
| Measure |
ProAir® Digihaler
n=100 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
|
|---|---|
|
Mean Number of Daily Doses AirDuo® Digihaler™.
|
0.99 doses per day
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the ProAir® Digihaler™.
This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.
Outcome measures
| Measure |
ProAir® Digihaler
n=100 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
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|---|---|
|
Median Number of Daily Doses of ProAir® Digihaler™
|
0.21 doses per day
Interval 0.03 to 0.52
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™.
This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.
Outcome measures
| Measure |
ProAir® Digihaler
n=100 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
|
|---|---|
|
Median Number of Daily Doses of AirDuo® Digihaler™
|
0.99 doses per day
Interval 0.21 to 1.66
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™.
This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Adherence rates were measured by the following: High (\>80% of puffs), moderate (50-80% of puffs), and low levels (\<50% of puffs) of adherence to maintenance inhalers over the course of the trial.
Outcome measures
| Measure |
ProAir® Digihaler
n=100 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
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|---|---|
|
Maintenace Inhaler Adherence Rates
High (>80% of puffs)
|
23 Participants
|
|
Maintenace Inhaler Adherence Rates
Moderate (50-80% of puffs)
|
25 Participants
|
|
Maintenace Inhaler Adherence Rates
Low levels (<50% of puffs)
|
52 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Because the outcome measure concerned response to biologics, all participants were included in this outcome, regardless of whether they chose to use either Digihaler or not.
All participants were provided the AirDuo® and ProAir® Digihalers, which they could choose to use or not. Responses were categorized as non-response, partial response, and complete response on the basis of five factors: a 50% reduction in exacerbations, any reduction in maintenance oral corticosteroids (OCS) dose, change of at least 10% in forced expiratory volume in one second (FEV1), improvement of 3 points in asthma control test (ACT) score, and patient perception of global improvement in asthma. Non-response indicated that a participant had no response to any of the 5 factors. Partial response indicated that a participant responded to at least 1 factor. Complete response indicated that a participant responded to all 5 factors.
Outcome measures
| Measure |
ProAir® Digihaler
n=100 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
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|---|---|
|
Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics
Non-response
|
3 Participants
|
|
Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics
Partial response
|
82 Participants
|
|
Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics
Complete response
|
15 Participants
|
SECONDARY outcome
Timeframe: baseline to 1 yearPopulation: Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller.
Peak inhalation volume is the maximum air volume a person can breathe in during a deep inhalation, serving as an indicator of lung capacity and respiratory function. Peak inhalation volume was measured by the digital inhaler at the end of inhalation. This measures the maximum volume that the participant was able to draw into their lungs. Larger numbers indicated healthier lungs.
Outcome measures
| Measure |
ProAir® Digihaler
n=48 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
|
|---|---|
|
Change in Mean Peak Inhalation Volume
Baseline - AirDuo
|
2436.48 milliliters
Standard Deviation 1328.27
|
|
Change in Mean Peak Inhalation Volume
Follow Up/Exacerbation - AirDuo
|
2041.79 milliliters
Standard Deviation 803.00
|
|
Change in Mean Peak Inhalation Volume
Baseline - ProAir
|
2147.69 milliliters
Standard Deviation 1201.34
|
|
Change in Mean Peak Inhalation Volume
Follow Up/Exacerbation - ProAir
|
1833.74 milliliters
Standard Deviation 806.61
|
SECONDARY outcome
Timeframe: baseline to 1 yearPopulation: Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller.
Inspiratory time was the total time taken to complete an inspiration (i.e., breathing in). Results were differences between the baseline and exacerbation measurements.
Outcome measures
| Measure |
ProAir® Digihaler
n=48 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
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|---|---|
|
Change in Mean Inspiratory Time
Baseline - AirDuo
|
2002.99 Seconds
Standard Deviation 853.03
|
|
Change in Mean Inspiratory Time
Follow Up/Exacerbation - AirDuo
|
1755.44 Seconds
Standard Deviation 692.41
|
|
Change in Mean Inspiratory Time
Baseline - ProAir
|
2268.19 Seconds
Standard Deviation 919.78
|
|
Change in Mean Inspiratory Time
Follow Up/Exacerbation - ProAir
|
1982.48 Seconds
Standard Deviation 756.34
|
SECONDARY outcome
Timeframe: baseline up to 1 yearPopulation: Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller.
PIF is the maximum rate of airflow a person can inhale using an inhaler after a full breath. PIF was measured by the ProAir® Digihaler™ and AirDuo® Digihaler™. Results indicate the changes between the baseline and exacerbation measurements.
Outcome measures
| Measure |
ProAir® Digihaler
n=48 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
|
|---|---|
|
Change in Mean Peak Inspiratory Flow (PIF)
Baseline - AirDuo
|
103.41 Liters per minute
Standard Deviation 35.02
|
|
Change in Mean Peak Inspiratory Flow (PIF)
Follow Up/Exacerbation - AirDuo
|
99.04 Liters per minute
Standard Deviation 29.58
|
|
Change in Mean Peak Inspiratory Flow (PIF)
Baseline - ProAir
|
79.60 Liters per minute
Standard Deviation 27.08
|
|
Change in Mean Peak Inspiratory Flow (PIF)
Follow Up/Exacerbation - ProAir
|
77.14 Liters per minute
Standard Deviation 23.61
|
SECONDARY outcome
Timeframe: baseline up to 1 yearPopulation: Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Home spirometry was not consistently used by all participants.
FEV1 was measured using the Go Spiro Spirometer. Results indicate the difference between the baseline and exacerbation measurements.
Outcome measures
| Measure |
ProAir® Digihaler
n=20 Participants
Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
|
|---|---|
|
Change in Mean Forced Expiratory Volume in One Second (FEV1)
Baseline
|
66.07 Liters
Standard Deviation 20.34
|
|
Change in Mean Forced Expiratory Volume in One Second (FEV1)
Follow Up/Exacerbation
|
68.43 Liters
Standard Deviation 19.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 1 yearOutcome measures
Outcome data not reported
Adverse Events
Not Using Either AirDuo or ProAir
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
After Using AirDuo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
After Using ProAir
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
After Using Both AirDuo and ProAir
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Not Using Either AirDuo or ProAir
n=16 participants at risk
Participants used neither inhaler during the course of the trial.
|
After Using AirDuo
n=84 participants at risk
Data reflects participants who experienced an AE within 1 month of using the AirDuo.
|
After Using ProAir
n=73 participants at risk
Data reflects participants who experienced an AE within 1 month of using the ProAir. 73 participants used ProAir at all during the trial.
|
After Using Both AirDuo and ProAir
n=73 participants at risk
Data reflects participants who experienced an AE within 1 month of using both AirDuo and ProAir inhalers together.73 participants used both AirDuo and ProAir during the trial.
|
|---|---|---|---|---|
|
Endocrine disorders
Adrenal Crisis
|
6.2%
1/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
6.2%
1/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
General disorders
Tremors & Generalized Weakness
|
0.00%
0/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
1.4%
1/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Infections and infestations
Influenza A
|
0.00%
0/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
1.4%
1/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Infections and infestations
Covid 19
|
0.00%
0/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
1.4%
1/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Gastrointestinal disorders
Gastroparesis
|
6.2%
1/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Blood and lymphatic system disorders
Graham Negative Rod Bacteremia
|
6.2%
1/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
0.00%
0/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
5.5%
4/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
1.4%
1/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
1.4%
1/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
1.4%
1/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Respiratory, thoracic and mediastinal disorders
Post-surgical low oxygen
|
6.2%
1/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
Other adverse events
| Measure |
Not Using Either AirDuo or ProAir
n=16 participants at risk
Participants used neither inhaler during the course of the trial.
|
After Using AirDuo
n=84 participants at risk
Data reflects participants who experienced an AE within 1 month of using the AirDuo.
|
After Using ProAir
n=73 participants at risk
Data reflects participants who experienced an AE within 1 month of using the ProAir. 73 participants used ProAir at all during the trial.
|
After Using Both AirDuo and ProAir
n=73 participants at risk
Data reflects participants who experienced an AE within 1 month of using both AirDuo and ProAir inhalers together.73 participants used both AirDuo and ProAir during the trial.
|
|---|---|---|---|---|
|
Infections and infestations
Covid 19
|
12.5%
2/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
4.8%
4/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
1.4%
1/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
12.3%
9/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Infections and infestations
Sinus Infection
|
6.2%
1/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
1.2%
1/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
6.8%
5/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
|
Infections and infestations
Upper Respiratory Infection
|
25.0%
4/16 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
2.4%
2/84 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
0.00%
0/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
5.5%
4/73 • Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place