Asthma
Conditions
Brief summary
To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines.
Interventions
DRUGfluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
fluticasone propionate/salmeterol diskus
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* must be able to speak, read, and understand English * exhaled Nitrous Oxide levels must be greater than or equal to 60 ppb at screening and greater than or equal to 55 ppb at Visits 2, 9, and 16 * must have history of at least 6 months of chronic, but stable asthma * except for the presence of asthma, subjects must be in general good health
Exclusion criteria
* past or present history of experiencing allergic reaction to medications used in this study * subjects must not be receiving ongoing regular treatment with inhaled corticosteroids * subjects must not have ragweed allergy * subjects must have no recent history of respiratory infections for at least 1 month prior to screening and until the end of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO) | Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Actual screened patients was 105. However, 22 eligible patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Patients Baseline measured for all randomized (safety set) patients. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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
| Characteristic | All Randomized Patients |
|---|---|
| Age, Continuous | 29.86 Years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 20 | 1 / 19 | 5 / 17 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 1 / 17 |
Outcome results
Primary
Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flu/Sal- 100mcg/50mcg | Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO) | 36.65 Percentage change in eNO | Standard Deviation 18.74 |
| Flu/Sal- 250mcg/50mcg | Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO) | 45.31 Percentage change in eNO | Standard Deviation 16.46 |
| Flu/Sal- 500mcg/50mcg | Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO) | 54.58 Percentage change in eNO | Standard Deviation 12.55 |