Trial Outcomes & Findings for Asthma Intervention Research (AIR) Trial (NCT NCT00214526)
NCT ID: NCT00214526
Last Updated: 2015-08-28
Results Overview
Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Baseline, 12 Months
Results posted on
2015-08-28
Participant Flow
Participant milestones
| Measure |
Alair Group
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Randomized
STARTED
|
56
|
56
|
|
Randomized
COMPLETED
|
55
|
54
|
|
Randomized
NOT COMPLETED
|
1
|
2
|
|
Treatment Period
STARTED
|
55
|
54
|
|
Treatment Period
COMPLETED
|
53
|
49
|
|
Treatment Period
NOT COMPLETED
|
2
|
5
|
|
Post-Treatment Period
STARTED
|
53
|
49
|
|
Post-Treatment Period
COMPLETED
|
52
|
49
|
|
Post-Treatment Period
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Asthma Intervention Research (AIR) Trial
Baseline characteristics by cohort
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.36 years
STANDARD_DEVIATION 11.18 • n=99 Participants
|
41.65 years
STANDARD_DEVIATION 11.35 • n=107 Participants
|
40.50 years
STANDARD_DEVIATION 11.27 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=99 Participants
|
17 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 MonthsAverage change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)
|
-0.16 Exacerbations/Subject/Week
Standard Deviation 0.37
|
0.04 Exacerbations/Subject/Week
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPercent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
ON-LABA at 12 Weeks
|
3.65 Percent Change
Standard Deviation 17.54
|
0.32 Percent Change
Standard Deviation 12.37
|
|
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
OFF-LABA at 12 Weeks
|
5.28 Percent Change
Standard Deviation 12.00
|
4.00 Percent Change
Standard Deviation 24.22
|
|
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
OFF-LABA at 6 Months
|
7.29 Percent Change
Standard Deviation 15.58
|
5.17 Percent Change
Standard Deviation 17.67
|
|
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
OFF-LABA at 12 Months
|
8.33 Percent Change
Standard Deviation 20.73
|
3.94 Percent Change
Standard Deviation 20.49
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPercent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in post-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
ON-LABA at 12 Weeks
|
-0.13 Percent Change
Standard Deviation 12.03
|
-0.13 Percent Change
Standard Deviation 8.63
|
|
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
OFF-LABA at 12 Weeks
|
0.76 Percent Change
Standard Deviation 12.65
|
0.80 Percent Change
Standard Deviation 16.01
|
|
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
OFF-LABA at 6 Months
|
0.82 Percent Change
Standard Deviation 11.67
|
0.13 Percent Change
Standard Deviation 11.55
|
|
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
OFF-LABA at 12 Months
|
0.89 Percent Change
Standard Deviation 13.91
|
1.33 Percent Change
Standard Deviation 13.08
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsChange from Baseline at 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in "PC20" - provocative concentration of Provocholine (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from baseline. The patient inhales an aerosol of one or more concentrations of methacholine. The lower the concentration of methacholine that provokes a 20% (or greater) fall in FEV1, the more "responsive" or "hyperresponsive" the airways are. Conversely, a rise in methacholine PC20 indicates airways that have become less reactive.
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Methacholine PC20 (Change From Baseline)
OFF-LABA at 12 Weeks
|
0.64 mg/mL
Interval 0.37 to 1.09
|
0.37 mg/mL
Interval 0.24 to 0.58
|
|
Methacholine PC20 (Change From Baseline)
OFF-LABA at 6 Months
|
0.50 mg/mL
Interval 0.3 to 0.85
|
0.42 mg/mL
Interval 0.25 to 0.7
|
|
Methacholine PC20 (Change From Baseline)
OFF-LABA at 12 Months
|
0.61 mg/mL
Interval 0.36 to 1.03
|
0.50 mg/mL
Interval 0.31 to 0.8
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsChange from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in morning and evening Peak Expiratory Flow (PEF). The peak expiratory flow rate measures the maximal rate at which a person can exhale air.
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Evening PEF: OFF-LABA at 12 Months
|
37.70 L/min
Standard Deviation 50.53
|
9.88 L/min
Standard Deviation 40.95
|
|
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Morning PEF: ON-LABA at 12 Weeks
|
27.96 L/min
Standard Deviation 48.98
|
1.37 L/min
Standard Deviation 32.26
|
|
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Morning PEF: OFF-LABA at 12 Weeks
|
42.59 L/min
Standard Deviation 41.77
|
12.98 L/min
Standard Deviation 37.08
|
|
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Morning PEF: OFF-LABA at 6 Months
|
31.49 L/min
Standard Deviation 42.48
|
7.39 L/min
Standard Deviation 45.03
|
|
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Morning PEF: OFF-LABA at 12 Months
|
39.31 L/min
Standard Deviation 48.74
|
8.52 L/min
Standard Deviation 44.18
|
|
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Evening PEF: ON-LABA at 12 Weeks
|
29.85 L/min
Standard Deviation 49.11
|
0.57 L/min
Standard Deviation 32.51
|
|
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Evening PEF: OFF-LABA at 12 Weeks
|
38.23 L/min
Standard Deviation 48.97
|
12.58 L/min
Standard Deviation 32.69
|
|
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Evening PEF: OFF-LABA at 6 Months
|
29.38 L/min
Standard Deviation 46.35
|
9.53 L/min
Standard Deviation 41.39
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsChange from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Asthma Control Questionnaire (ACQ) Score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (best) to 6 (worst) and averaged, resulting in a total score from 0 to 6. A decrease in the ACQ score indicates better asthma control.
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
ON-LABA at 12 Weeks
|
-0.30 Units on a scale
Standard Deviation 0.77
|
-0.01 Units on a scale
Standard Deviation 0.68
|
|
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
OFF-LABA at 12 Weeks
|
-1.15 Units on a scale
Standard Deviation 1.01
|
-0.30 Units on a scale
Standard Deviation 1.02
|
|
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
OFF-LABA at 6 Months
|
-1.23 Units on a scale
Standard Deviation 0.98
|
-0.51 Units on a scale
Standard Deviation 0.97
|
|
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
OFF-LABA at 12 Months
|
-1.18 Units on a scale
Standard Deviation 1.02
|
-0.47 Units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsChange from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in use of rescue medications (short acting bronchodilators) measured in puffs per week. Subjects recorded their use of rescue medication for asthma symptoms in their Daily Diary throughout the study.
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Use of Rescue Medications (Change From Baseline)
ON-LABA at 12 Weeks
|
-3.62 Puffs/7 Days
Standard Deviation 11.97
|
0.94 Puffs/7 Days
Standard Deviation 12.10
|
|
Use of Rescue Medications (Change From Baseline)
OFF-LABA at 12 Weeks
|
-9.08 Puffs/7 Days
Standard Deviation 15.59
|
-2.56 Puffs/7 Days
Standard Deviation 12.75
|
|
Use of Rescue Medications (Change From Baseline)
OFF-LABA at 6 Months
|
-5.84 Puffs/7 Days
Standard Deviation 15.59
|
-1.26 Puffs/7 Days
Standard Deviation 14.10
|
|
Use of Rescue Medications (Change From Baseline)
OFF-LABA at 12 Months
|
-8.93 Puffs/7 Days
Standard Deviation 17.21
|
-1.17 Puffs/7 Days
Standard Deviation 16.71
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsChange from Baseline at 12-Months (OFF-LABA) Follow-up Visit in use of maintenance medications (inhaled corticosteroids and/or long-acting beta-agonists).
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Use of Maintenance Medications (Change From Baseline)
No Change in ICS Dosage
|
52 Subjects
|
52 Subjects
|
|
Use of Maintenance Medications (Change From Baseline)
Increase in ICS Dosage
|
1 Subjects
|
1 Subjects
|
|
Use of Maintenance Medications (Change From Baseline)
Decrease in ICS Dosage
|
2 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsChange from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in AQLQ score. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). The AQLQ score is the mean of the scores from the 32 individual questions. An increase in the AQLQ score indicates a better quality of life. A within-subject change in score of 0.5 represents the minimal important difference (MID).
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
ON-LABA at 12 Weeks
|
0.48 Units on a scale
Standard Deviation 0.94
|
0.01 Units on a scale
Standard Deviation 0.90
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
OFF-LABA at 12 Weeks
|
1.25 Units on a scale
Standard Deviation 1.18
|
0.29 Units on a scale
Standard Deviation 1.06
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
OFF-LABA at 6 Months
|
1.23 Units on a scale
Standard Deviation 1.10
|
0.54 Units on a scale
Standard Deviation 1.06
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
OFF-LABA at 12 Months
|
1.27 Units on a scale
Standard Deviation 1.01
|
0.58 Units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsChange from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Total Symptom Score. Total Symptom Score comprises the sum of six asthma symptom measurements. Each symptom is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.
Outcome measures
| Measure |
Alair Group
n=55 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
Control Group
n=54 Participants
Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
|
|---|---|---|
|
Total Symptom Score (Change From Baseline)
OFF-LABA at 6 Months
|
-1.60 Units on a scale
Standard Deviation 2.13
|
-0.66 Units on a scale
Standard Deviation 2.28
|
|
Total Symptom Score (Change From Baseline)
OFF-LABA at 12 Months
|
-1.91 Units on a scale
Standard Deviation 2.11
|
-0.65 Units on a scale
Standard Deviation 2.48
|
|
Total Symptom Score (Change From Baseline)
ON-LABA at 12 Weeks
|
-1.18 Units on a scale
Standard Deviation 2.16
|
-0.33 Units on a scale
Standard Deviation 1.89
|
|
Total Symptom Score (Change From Baseline)
OFF-LABA at 12 Weeks
|
-1.73 Units on a scale
Standard Deviation 2.13
|
-0.37 Units on a scale
Standard Deviation 2.24
|
Adverse Events
Alair (Treatment Period)
Serious events: 4 serious events
Other events: 53 other events
Deaths: 0 deaths
Control (Treatment Period)
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
Alair (Post-Treatment Period)
Serious events: 5 serious events
Other events: 52 other events
Deaths: 0 deaths
Control (Post-Treatment Period)
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alair (Treatment Period)
n=55 participants at risk
From first Treatment visit through 6 weeks after last Treatment visit.
|
Control (Treatment Period)
n=54 participants at risk
From first Control visit through 6 weeks after last Control visit.
|
Alair (Post-Treatment Period)
n=55 participants at risk
From 6 weeks after last Treatment visit through 1 year.
|
Control (Post-Treatment Period)
n=54 participants at risk
From 6 weeks after last Control visit through 1 year.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.5%
3/55
|
0.00%
0/54
|
3.6%
2/55
|
1.9%
1/54
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
1.9%
1/54
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Collapse Of Lung (Partial Collapse Of Left Upper Lobe)
|
1.8%
1/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/55
|
1.9%
1/54
|
0.00%
0/55
|
1.9%
1/54
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Nervous system disorders
Headache
|
0.00%
0/55
|
0.00%
0/54
|
1.8%
1/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection Pseudomonal
|
0.00%
0/55
|
0.00%
0/54
|
1.8%
1/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.8%
1/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Infections and infestations
Sepsis
|
0.00%
0/55
|
0.00%
0/54
|
1.8%
1/55
|
0.00%
0/54
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/54
|
Other adverse events
| Measure |
Alair (Treatment Period)
n=55 participants at risk
From first Treatment visit through 6 weeks after last Treatment visit.
|
Control (Treatment Period)
n=54 participants at risk
From first Control visit through 6 weeks after last Control visit.
|
Alair (Post-Treatment Period)
n=55 participants at risk
From 6 weeks after last Treatment visit through 1 year.
|
Control (Post-Treatment Period)
n=54 participants at risk
From 6 weeks after last Control visit through 1 year.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Abnormal Chest Sound
|
5.5%
3/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Psychiatric disorders
Anxiety
|
5.5%
3/55
|
0.00%
0/54
|
0.00%
0/55
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
2/55
|
1.9%
1/54
|
5.5%
3/55
|
7.4%
4/54
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.5%
3/55
|
1.9%
1/54
|
5.5%
3/55
|
7.4%
4/54
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Irritation
|
9.1%
5/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.3%
4/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Chest Discomfort
|
29.1%
16/55
|
18.5%
10/54
|
20.0%
11/55
|
13.0%
7/54
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
25.5%
14/55
|
5.6%
3/54
|
1.8%
1/55
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
52.7%
29/55
|
18.5%
10/54
|
38.2%
21/55
|
35.2%
19/54
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
2/55
|
0.00%
0/54
|
5.5%
3/55
|
3.7%
2/54
|
|
Nervous system disorders
Dizziness
|
5.5%
3/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
3/55
|
1.9%
1/54
|
5.5%
3/55
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
69.1%
38/55
|
31.5%
17/54
|
47.3%
26/55
|
51.9%
28/54
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exacerbated
|
7.3%
4/55
|
1.9%
1/54
|
1.8%
1/55
|
0.00%
0/54
|
|
Infections and infestations
Ear Infection
|
0.00%
0/55
|
0.00%
0/54
|
5.5%
3/55
|
5.6%
3/54
|
|
General disorders
Fatigue
|
9.1%
5/55
|
0.00%
0/54
|
5.5%
3/55
|
1.9%
1/54
|
|
Nervous system disorders
Headache
|
27.3%
15/55
|
18.5%
10/54
|
27.3%
15/55
|
25.9%
14/54
|
|
Immune system disorders
Hypersensitivity
|
1.8%
1/55
|
1.9%
1/54
|
3.6%
2/55
|
5.6%
3/54
|
|
Infections and infestations
Influenza
|
0.00%
0/55
|
1.9%
1/54
|
5.5%
3/55
|
1.9%
1/54
|
|
General disorders
Influenza Like Illness
|
1.8%
1/55
|
0.00%
0/54
|
5.5%
3/55
|
0.00%
0/54
|
|
Nervous system disorders
Migraine
|
1.8%
1/55
|
0.00%
0/54
|
5.5%
3/55
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
3/55
|
3.7%
2/54
|
0.00%
0/55
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
12.7%
7/55
|
11.1%
6/54
|
27.3%
15/55
|
25.9%
14/54
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
5.5%
3/55
|
3.7%
2/54
|
10.9%
6/55
|
5.6%
3/54
|
|
Gastrointestinal disorders
Nausea
|
14.5%
8/55
|
5.6%
3/54
|
9.1%
5/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal Dyspnoea
|
40.0%
22/55
|
9.3%
5/54
|
12.7%
7/55
|
9.3%
5/54
|
|
Infections and infestations
Oral Candidiasis
|
5.5%
3/55
|
3.7%
2/54
|
0.00%
0/55
|
3.7%
2/54
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
5.5%
3/55
|
5.6%
3/54
|
10.9%
6/55
|
13.0%
7/54
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
36.4%
20/55
|
9.3%
5/54
|
20.0%
11/55
|
20.4%
11/54
|
|
General disorders
Pyrexia
|
5.5%
3/55
|
1.9%
1/54
|
1.8%
1/55
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
3.6%
2/55
|
1.9%
1/54
|
9.1%
5/55
|
3.7%
2/54
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
10.9%
6/55
|
1.9%
1/54
|
9.1%
5/55
|
16.7%
9/54
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/55
|
5.6%
3/54
|
1.8%
1/55
|
3.7%
2/54
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Discoloured
|
16.4%
9/55
|
1.9%
1/54
|
7.3%
4/55
|
3.7%
2/54
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/55
|
0.00%
0/54
|
5.5%
3/55
|
0.00%
0/54
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/55
|
0.00%
0/54
|
5.5%
3/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
12.7%
7/55
|
3.7%
2/54
|
18.2%
10/55
|
5.6%
3/54
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/55
|
0.00%
0/54
|
5.5%
3/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
3/55
|
1.9%
1/54
|
3.6%
2/55
|
3.7%
2/54
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
61.8%
34/55
|
13.0%
7/54
|
29.1%
16/55
|
22.2%
12/54
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60