Trial Outcomes & Findings for Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program (NCT NCT02024204)
NCT ID: NCT02024204
Last Updated: 2021-02-02
Results Overview
Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Week 12
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
Visit 1 Uncontrolled LRS
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
11
|
|
Overall Study
COMPLETED
|
49
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
Baseline characteristics by cohort
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=39 Participants
|
56 years
n=41 Participants
|
56.5 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
26 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
NH-White
|
10 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
NH-Black
|
12 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian and Other
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=39 Participants
|
11 participants
n=41 Participants
|
60 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Week 12Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Forced Oscillation Technique (FOT) Measures
Pre BD R5
|
4.4 resonant frequency
Interval 3.4 to 5.7
|
3.7 resonant frequency
Interval 3.3 to 5.7
|
|
Forced Oscillation Technique (FOT) Measures
Pre BD R5-20
|
1.0 resonant frequency
Interval 0.5 to 1.5
|
0.6 resonant frequency
Interval 0.4 to 1.4
|
|
Forced Oscillation Technique (FOT) Measures
Post BD R5
|
4.1 resonant frequency
Interval 3.5 to 5.3
|
4.0 resonant frequency
Interval 3.4 to 5.7
|
|
Forced Oscillation Technique (FOT) Measures
Post BD R5-20
|
0.8 resonant frequency
Interval 0.4 to 1.2
|
0.6 resonant frequency
Interval 0.4 to 1.1
|
PRIMARY outcome
Timeframe: Week 12Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters). FEV1 = forced expiratory volume at 1 second FVC = forced vital capacity
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Spirometry Measures
Pre-BD FEV1/FVC
|
78.5 % FEV1(Liters)/FVC(Liters)
Interval 72.4 to 82.4
|
81.2 % FEV1(Liters)/FVC(Liters)
Interval 75.3 to 83.4
|
|
Spirometry Measures
Post-BD FEV1/FVC
|
78.3 % FEV1(Liters)/FVC(Liters)
Interval 75.0 to 82.2
|
77.7 % FEV1(Liters)/FVC(Liters)
Interval 75.4 to 81.1
|
SECONDARY outcome
Timeframe: Week 12To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
|
18 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 12measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)
|
21 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 1IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Total IgE (Immunoglobulin E) Levels
|
41 ng/mL
Interval 20.0 to 135.0
|
31 ng/mL
Interval 21.5 to 57.0
|
SECONDARY outcome
Timeframe: Week 1EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Total EoS (Eosinophil) Counts
|
.10 eosiniphils *10^9/Liter
Interval 0.1 to 0.2
|
.10 eosiniphils *10^9/Liter
Interval 0.1 to 0.1
|
SECONDARY outcome
Timeframe: Week 12Measured using a portable device that measures the level of nitric oxide in parts per billion (PPB) in the air slowly exhaled out of the patient's lungs.
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Levels of Fractional Exhaled Nitric Oxide (FeNO)
|
17.8 parts per billion (ppb)
Interval 14.0 to 22.2
|
13 parts per billion (ppb)
Interval 10.2 to 13.9
|
SECONDARY outcome
Timeframe: Week 12Voice Handicap Index 10 is a measure of laryngeal dysfunction or hypersensitivity to capture the "overall" state of voice handicap. The normative value for this instrument is 2.83, with a score \> 11 considered abnormal. There are 10 statements that are scored between 0 and 4 (0= never, 4= always). The total range is 0-40, where 40 is highest level of dysfunction.
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Score on Voice Handicap Index 10 (VHI-10)
|
7 score on VHI-10 scale
Interval 1.0 to 17.0
|
1 score on VHI-10 scale
Interval 0.0 to 9.8
|
SECONDARY outcome
Timeframe: Week 12For rhinosinusitis symptoms, the ICSD scoring system was used, with a likert scale of 1-10 for each symptom (total range of scale = 1-60, with higher scores reflecting more symptoms).
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)
|
35 score on ICSD scale
Interval 24.0 to 42.5
|
26 score on ICSD scale
Interval 18.2 to 29.5
|
SECONDARY outcome
Timeframe: Week 12For rhinosinusitis symptoms, the Leicester Cough Questionnaire (LCQ) was used - a cough-specific health status questionnaire that assesses the physical, psychological, and social domains of cough. The LCQ is made up of 19 items; the total score range is 3-21; a higher score is associated with better health.
Outcome measures
| Measure |
Visit 1 Uncontrolled LRS
n=49 Participants
Patients who have uncontrolled LRS (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Fluticasone propionate 230mcg for 3 Months
Salmeterol 21mcg for 3 Months
|
Visit 1 Controlled LRS
n=11 Participants
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
|
|---|---|---|
|
Score on Leicester Cough Questionnaire (LCQ)
|
12 score on LCQ scale
Interval 8.9 to 15.4
|
15.6 score on LCQ scale
Interval 12.7 to 20.2
|
Adverse Events
Uncontrolled LRS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controlled LRS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place