Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair

Conditions
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Asthma

Intervention / Treatment
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* Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg<br>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. | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg<br>* fluticasone propionate/salmeterol diskus<br>* Other names: Advair DISKUS;|
| Active Comparator: Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg<br>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. | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg<br>* fluticasone propionate/salmeterol diskus<br>* Other names: Advair DISKUS;|
| Active Comparator: Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg<br>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. | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg<br>* fluticasone propionate/salmeterol diskus<br>* Other names: Advair DISKUS;|
| Active Comparator: Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg<br>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. | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg<br>* fluticasone propionate/salmeterol diskus<br>* Other names: Advair DISKUS;|
| Active Comparator: Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg<br>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. | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg<br>* fluticasone propionate/salmeterol diskus<br>* Other names: Advair DISKUS;|
| Active Comparator: Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg<br>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. | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg<br>* fluticasone propionate/salmeterol diskus<br>* Other names: Advair DISKUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks) |