Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517634
• Other study ID #: HZA109912
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2007
• Last updated: March 13, 2014
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• FP
Fluticasone Propionate 100 mcg BD
• SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
• Placebo
Matching Placebo

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Manchester
United States	GSK Investigational Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35	Number of peripheral blood eosinophils measured from blood draws	0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35	No
Secondary	Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14	Number of peripheral blood eosinophils measured from blood draws	0-6 hours, post allergen challenge, 1 hour post treatment, Day 14	No
Secondary	Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35	Amount of serum interleukin (IL)-5 measured from blood draws	0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35	No
Secondary	Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14	Amount of serum IL-5 measured from blood draws	0-6 hours post allergen challenge, 1 hour after dosing, Day 14	No