Trial Outcomes & Findings for Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair (NCT NCT00927758)
NCT ID: NCT00927758
Last Updated: 2017-03-29
Results Overview
Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)
Results posted on
2017-03-29
Participant Flow
Actual screened patients was 105. However, 22 eligible patients were randomized.
Participant milestones
| Measure |
Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
|---|---|---|---|---|---|---|
|
Treatment Cycle 1 (Day 1 - Day 7)
STARTED
|
4
|
4
|
4
|
3
|
3
|
4
|
|
Treatment Cycle 1 (Day 1 - Day 7)
Intent to Treat (ITT)
|
4
|
4
|
4
|
2
|
3
|
3
|
|
Treatment Cycle 1 (Day 1 - Day 7)
COMPLETED
|
4
|
4
|
4
|
2
|
3
|
3
|
|
Treatment Cycle 1 (Day 1 - Day 7)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Treatment Cycle 2 (Day 1 - Day 7)
STARTED
|
4
|
4
|
4
|
2
|
3
|
3
|
|
Treatment Cycle 2 (Day 1 - Day 7)
Per Protocol Population (PP)
|
4
|
4
|
3
|
1
|
3
|
2
|
|
Treatment Cycle 2 (Day 1 - Day 7)
COMPLETED
|
4
|
4
|
3
|
1
|
3
|
2
|
|
Treatment Cycle 2 (Day 1 - Day 7)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Treatment Cycle 3 (Day 1 - Day 7)
STARTED
|
4
|
4
|
3
|
1
|
3
|
2
|
|
Treatment Cycle 3 (Day 1 - Day 7)
COMPLETED
|
4
|
4
|
3
|
1
|
3
|
2
|
|
Treatment Cycle 3 (Day 1 - Day 7)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg
Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles.
|
|---|---|---|---|---|---|---|
|
Treatment Cycle 1 (Day 1 - Day 7)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Treatment Cycle 2 (Day 1 - Day 7)
Did not meet eNO criteria
|
0
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
Baseline characteristics by cohort
| Measure |
All Randomized Patients
n=22 Participants
Baseline measured for all randomized (safety set) patients.
|
|---|---|
|
Age, Continuous
|
29.86 Years
STANDARD_DEVIATION 10.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)Population: The per-protocol (PP) population was all subjects who completed the study with no major variances that would impair the analysis of the data
Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.
Outcome measures
| Measure |
Flu/Sal- 100mcg/50mcg
n=17 Participants
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
|
Flu/Sal- 250mcg/50mcg
n=17 Participants
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
|
Flu/Sal- 500mcg/50mcg
n=17 Participants
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
|
|---|---|---|---|
|
Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
|
36.65 Percentage change in eNO
Standard Deviation 18.74
|
45.31 Percentage change in eNO
Standard Deviation 16.46
|
54.58 Percentage change in eNO
Standard Deviation 12.55
|
Adverse Events
Flu/Sal- 100mcg/50mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Flu/Sal- 250mcg/50mcg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Flu/Sal- 500mcg/50mcg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flu/Sal- 100mcg/50mcg
n=20 participants at risk
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
|
Flu/Sal- 250mcg/50mcg
n=19 participants at risk
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
|
Flu/Sal- 500mcg/50mcg
n=17 participants at risk
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/20
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/19
Safety set includes all subjects who received at least one dose of drug.
|
5.9%
1/17
Safety set includes all subjects who received at least one dose of drug.
|
Other adverse events
| Measure |
Flu/Sal- 100mcg/50mcg
n=20 participants at risk
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
|
Flu/Sal- 250mcg/50mcg
n=19 participants at risk
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
|
Flu/Sal- 500mcg/50mcg
n=17 participants at risk
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
|
|---|---|---|---|
|
Infections and infestations
Viral Upper respiratory infection
|
5.0%
1/20
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/19
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/17
Safety set includes all subjects who received at least one dose of drug.
|
|
Infections and infestations
Upper Respiratory infection
|
5.0%
1/20
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/19
Safety set includes all subjects who received at least one dose of drug.
|
17.6%
3/17
Safety set includes all subjects who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Asthma
|
0.00%
0/20
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/19
Safety set includes all subjects who received at least one dose of drug.
|
11.8%
2/17
Safety set includes all subjects who received at least one dose of drug.
|
|
Eye disorders
Dilated, Dry Eyes
|
0.00%
0/20
Safety set includes all subjects who received at least one dose of drug.
|
5.3%
1/19
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/17
Safety set includes all subjects who received at least one dose of drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/19
Safety set includes all subjects who received at least one dose of drug.
|
5.9%
1/17
Safety set includes all subjects who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/19
Safety set includes all subjects who received at least one dose of drug.
|
5.9%
1/17
Safety set includes all subjects who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/19
Safety set includes all subjects who received at least one dose of drug.
|
0.00%
0/17
Safety set includes all subjects who received at least one dose of drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Sandoz's agreements with its investigators may vary. However, Sandoz does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER