Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00517634
First received: August 16, 2007
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: FP
Drug: SFC
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35 [ Time Frame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 ] [ Designated as safety issue: No ]
    Number of peripheral blood eosinophils measured from blood draws


Secondary Outcome Measures:
  • Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14 [ Time Frame: 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-6 hours post allergen challenge, 1 hour after dosing, Day 14 ] [ Designated as safety issue: No ]
    Amount of serum IL-5 measured from blood draws


Enrollment: 23
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Drug: Placebo
Matching Placebo
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: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Drug: Placebo
Matching Placebo
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: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Drug: Placebo
Matching Placebo
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: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Drug: Placebo
Matching Placebo
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: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Drug: Placebo
Matching Placebo
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: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Drug: Placebo
Matching Placebo

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517634

Locations
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
United Kingdom
GSK Investigational Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00517634     History of Changes
Other Study ID Numbers: HZA109912
Study First Received: August 16, 2007
Results First Received: July 23, 2009
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
asthma
allergen challenge
IL-5
eosinophils

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014