Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00517634

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: fluticasone propionate/salmeterol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

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)

Intervention Details:

Other Name: fluticasone propionate/salmeterol

Detailed Description:

A 19-week, randomized, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate 50/100mcg BID, fluticasone propionate 100mcg BID and placebo on blood markers of airway inflammation in response to allergen challenge in asthma subjects

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

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, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
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 9, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

asthma
eosinophils
IL-5
allergen challenge

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012