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

Sandoz105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

105

Conditions

Asthma

Interventions

fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgDRUG

fluticasone propionate/salmeterol diskus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Florida

Gainesville, Florida, United States

CompleWare

Iowa City, Iowa, United States

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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