Study With GW274150 In Patients With Mild Asthma - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00273013

Purpose

This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.

Condition	Intervention	Phase
Asthma	Drug: GW274150 Drug: Singulair	Phase I

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study
Official Title:	A Two-Centre, Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Period Cross-Over Study to Evaluate the Effect of Treatment With Repeat Doses of GW274150 on the Allergen-Induced Late Asthmatic Response in Subjects With Mild Asthma.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Effect on the late asthmatic reaction following an inhaled allergen challenge

Secondary Outcome Measures:

Measures of safety. Measures of lung function

Estimated Enrollment:	28
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Mild asthma: taking reliever medication (e.g. salbutamol) only.
Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study.

Exclusion criteria:

Recent steroid treatment.
Significant illnesses or diseases other than asthma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273013

Locations

United Kingdom
GSK Investigational Site
London, United Kingdom, SE1 9RT
United Kingdom, Lancashire
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, BM BCh DM

GlaxoSmithKline

More Information

Publications indexed to this study:

Singh D, Richards D, Knowles RG, Schwartz S, Woodcock A, Langley S, O'Connor BJ. Selective inducible nitric oxide synthase inhibition has no effect on allergen challenge in asthma. Am J Respir Crit Care Med. 2007 Nov 15;176(10):988-93. Epub 2007 Aug 23.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	INO102141
Study First Received:	January 4, 2006
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00273013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

asthma
allergen challenge

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009