Clinical trial NCT00517634: Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
Official title: A 12-week, Randomised, Double-blind, Placebo-controlled, Three-period, Cross-over Pilot Study Comparing the Effect of Salmeterol/Fluticasone Propionate, Fluticasone Propionate and Placebo on Perpheral Blood Eosinophils and Serum IL-5 in Response to Allergen Challenge in Asthma Subjects When Allergen Challenge is Administered at 1 Hour or 11-12 Hours Post-dose of the Dosing Interval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
allergen challenge
IL-5
eosinophils
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval

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 \<8mg/mL.
* Demonstration of atopy

Exclusion Criteria:

* History of life-threatening asthma.
* Use of proscribed asthma medications.
* Use of anti-histamines or potent inhibitors of CYP3A4.
* Respiratory tract infection.
* Asthma exacerbation with 4 weeks of Visit 1.
* Subjects with exercise induced asthma only.
* Concurrent respiratory disease.
* Other clinically significant, uncontrolled condition or disease.
* Use of any investigational drug within 30 days.
* Allergic to beta-2-agonists, inhaled corticosteroids or excipients.
* Positive pregnancy test.
* Using immunosuppressive medications.
* Milk protein allergy.
* Factors likely to interfere with attendance.
* Current smokers or ex-smokers with a history of \>10 pack years.
* Affiliation wih Investigator site.
* Medications that may affect the course of asthma or interact with sympathomimetic amines.

Primary outcomes:
measure: Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35
timeFrame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35
Secondary outcomes:
measure: Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14
timeFrame: 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14
measure: Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35
timeFrame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35
measure: Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14
timeFrame: 0-6 hours post allergen challenge, 1 hour after dosing, Day 14
Other outcomes:
Locations:
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: