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

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00927758
• Lead Sponsor: Sandoz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-04
• Results First Submitted: 2014-04-22
• Results First Submitted QC: 2014-08-29
• Results First Posted: 2014-09-08
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

University of Florida; 🇺🇸 Gainesville, Florida, United States

CompleWare; 🇺🇸 Iowa City, Iowa, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States