Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
Information source: Sandoz Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sandoz Inc.
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.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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 and Contacts
University of Florida, Gainesville, Florida 32610-0486, United States
CompleWare, Iowa City, Iowa 52244, United States
University of Wisconsin, Madison, Wisconsin 53792, United States
Additional Information
Starting date: June 2009
Last updated: August 29, 2014
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