Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: FP; Drug: SFC

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • GSK Investigational Site
• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: FP, SFC, 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	Drug: Placebo; Matching Placebo; Drug: FP; Fluticasone Propionate 100 mcg BD; Drug: SFC; Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 2: Placebo, SFC, 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	Drug: Placebo; Matching Placebo; Drug: FP; Fluticasone Propionate 100 mcg BD; Drug: SFC; Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 3: SFC, FP, 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	Drug: Placebo; Matching Placebo; Drug: FP; Fluticasone Propionate 100 mcg BD; Drug: SFC; Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 4: SFC, Placebo, 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	Drug: Placebo; Matching Placebo; Drug: FP; Fluticasone Propionate 100 mcg BD; Drug: SFC; Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 5: FP, Placebo, 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	Drug: Placebo; Matching Placebo; Drug: FP; Fluticasone Propionate 100 mcg BD; Drug: SFC; Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 6: Placebo, FP, 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	Drug: Placebo; Matching Placebo; Drug: FP; Fluticasone Propionate 100 mcg BD; Drug: SFC; Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: August 16, 2007
• First Submitted That Met QC Criteria: August 16, 2007
• First Posted (Estimate): August 17, 2007

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: asthma; allergen challenge; eosinophils; IL-5
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: HZA109912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: HZA109912
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Annotated Case Report Form
   Information identifier: HZA109912
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: HZA109912
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: HZA109912
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: HZA109912
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Dataset Specification
   Information identifier: HZA109912
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Informed Consent Form
   Information identifier: HZA109912
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register