Phase 4
N=23
Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00517634 ↗Enrolled (actual)
23
Serious AEs
1.5%
Results posted
Sep 2009
Primary outcome: Primary: Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35 — -0.050; -0.040; -0.023 Giga Units per Liter (GI/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FP (Drug); SFC (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35 |
-0.050; -0.040; -0.023 | — |
| SECONDARY Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14 |
-0.023; -0.022; -0.013 | — |
| SECONDARY Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35 |
— | — |
| SECONDARY Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14 |
— | — |
Summary
The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.
Eligibility Criteria
Inclusion Criteria
- Informed consent.
- Outpatient.
- Male or non-pregnant/non-lactating female.
- Aged 18-55.
- Diagnosis of asthma.
- Pre-bronchodilatory FEV1 > 75% predicted.
- Using inhaled short-acting beta-2-agonists (SABA) with no inhaled corticosteroids.
- Judged capable of withholding SABA for at least 6 hours prior to visits.
- Reversibility of >12% and 200mL or PC20 of 10 pack years.
- Affiliation wih Investigator site.
- Medications that may affect the course of asthma or interact with sympathomimetic amines.
Data sourced from ClinicalTrials.gov (NCT00517634). 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.