Phase 4
Completed N=7
Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?
Mild Intermittent Asthma
Source: ClinicalTrials.gov NCT00716963 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1. — -30.5; -39.0; -31.9 percentage fall FEV1
Summary
The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded, randomized, crossover study in which single doses of placebo, will be compared to Fluticasone propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from post-allergen peak)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1. |
-30.5; -39.0; -31.9 | — |
| PRIMARY The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1. |
-11.6; -14.7; -24 | — |
| SECONDARY The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils). |
— | — |
| SECONDARY The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils) |
— | — |
Eligibility Criteria
Inclusion Criteria
- mild asthma
- nonsmokers
- allergen-induced early and late asthmatic response
Exclusion Criteria
- no medication other than infrequent ( < twice weekly) inhaled beta2-agonists
- not be exposed to sensitizing allergens
- asthma exacerbation or respiratory tract infection in the past4 weeks
Data sourced from ClinicalTrials.gov (NCT00716963). 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.