Status:

COMPLETED

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

Lead Sponsor:

Sandoz

Conditions:

Asthma

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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) guid...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

105 Patients enrolled

Trial Details

Trial ID

NCT00927758

Start Date

June 1 2009

End Date

December 1 2009

Last Update

March 29 2017

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Florida

Gainesville, Florida, United States, 32610-0486

2

CompleWare

Iowa City, Iowa, United States, 52244

3

University of Wisconsin

Madison, Wisconsin, United States, 53792