Phase 2 Completed N=22 Randomized Quadruple-blind Treatment

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

Source: ClinicalTrials.gov NCT00927758 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Sep 2014

Primary outcomePrimary: Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO) — 36.65; 45.31; 54.58 Percentage change in eNO

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)	36.65; 45.31; 54.58	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00927758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.