Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: FP; Drug: SFC; Drug: Placebo

• Registration Number: NCT00517634
• Lead Sponsor: GlaxoSmithKline

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

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-17
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-23
• Results First Submitted QC: 2009-07-23
• Results First Posted: 2009-09-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequence 1: FP, SFC, Placebo	Placebo	Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 2: Placebo, SFC, FP	SFC	Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Sequence 2: Placebo, SFC, FP	Placebo	Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Sequence 3: SFC, FP, Placebo	SFC	Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 3: SFC, FP, Placebo	Placebo	Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 1: FP, SFC, Placebo	FP	Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 1: FP, SFC, Placebo	SFC	Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 3: SFC, FP, Placebo	FP	Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 4: SFC, Placebo, FP	FP	Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Sequence 4: SFC, Placebo, FP	Placebo	Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Sequence 2: Placebo, SFC, FP	FP	Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Sequence 4: SFC, Placebo, FP	SFC	Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Sequence 5: FP, Placebo, SFC	FP	Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Sequence 5: FP, Placebo, SFC	Placebo	Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Sequence 6: Placebo, FP, SFC	FP	Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Sequence 6: Placebo, FP, SFC	Placebo	Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Sequence 5: FP, Placebo, SFC	SFC	Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Sequence 6: Placebo, FP, SFC	SFC	Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period

Primary Outcome Measures

Name	Time	Method
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35	0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35	Number of peripheral blood eosinophils measured from blood draws

Secondary Outcome Measures

Name	Time	Method
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14	0-6 hours, post allergen challenge, 1 hour post treatment, Day 14	Number of peripheral blood eosinophils measured from blood draws
Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35	0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35	Amount of serum interleukin (IL)-5 measured from blood draws
Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14	0-6 hours post allergen challenge, 1 hour after dosing, Day 14	Amount of serum IL-5 measured from blood draws

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Manchester, United Kingdom