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.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: ADVAIR (fluticasone propionate/salmeterol) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sandoz Inc. Overall contact:
Jurgita Zdanaviciene, BSN, Phone: 608-263-6185
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study
Primary outcome: To examine the post-dose changes in eNO following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines
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 less than or equal to 60 ppb at screening and 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
Jurgita Zdanaviciene, BSN, Phone: 608-263-6185
University of Wisconsin, Madison, Wisconsin 53792, United States; Recruiting
Jurgita Zdanaviciene, BSN, Phone: 608-263-6185
Additional Information
Starting date: June 2009
Ending date: October 2009
Last updated: June 25, 2009
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