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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

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

Page last updated: August 23, 2015

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