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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Nitric Oxide; Salmeterol Xinafoate; Xhance

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