Study With GW274150 In Patients With Mild Asthma

Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: GW274150; Drug: Singulair; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

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

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.	Drug: GW274150; GW274150 will be available as 30 mg white oval tablets.; Drug: Singulair; Singulair will be available as over encapsulated 10 mg orange tablets.; Other Names: GW274150; Drug: Placebo; Matching placebo for Singulair and GW274150 will be available.
Experimental: Sequence 2; Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.	Drug: GW274150; GW274150 will be available as 30 mg white oval tablets.; Drug: Singulair; Singulair will be available as over encapsulated 10 mg orange tablets.; Other Names: GW274150; Drug: Placebo; Matching placebo for Singulair and GW274150 will be available.
Experimental: Sequence 3; Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.	Drug: GW274150; GW274150 will be available as 30 mg white oval tablets.; Drug: Singulair; Singulair will be available as over encapsulated 10 mg orange tablets.; Other Names: GW274150; Drug: Placebo; Matching placebo for Singulair and GW274150 will be available.
Experimental: Sequence 4; Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.	Drug: GW274150; GW274150 will be available as 30 mg white oval tablets.; Drug: Singulair; Singulair will be available as over encapsulated 10 mg orange tablets.; Other Names: GW274150; Drug: Placebo; Matching placebo for Singulair and GW274150 will be available.
Experimental: Sequence 5; Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.	Drug: GW274150; GW274150 will be available as 30 mg white oval tablets.; Drug: Singulair; Singulair will be available as over encapsulated 10 mg orange tablets.; Other Names: GW274150; Drug: Placebo; Matching placebo for Singulair and GW274150 will be available.
Experimental: Sequence 6; Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.	Drug: GW274150; GW274150 will be available as 30 mg white oval tablets.; Drug: Singulair; Singulair will be available as over encapsulated 10 mg orange tablets.; Other Names: GW274150; Drug: Placebo; Matching placebo for Singulair and GW274150 will be available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect on the late asthmatic reaction following an inhaled allergen challenge	Up to Day 115

Secondary Outcome Measures

Outcome Measure	Time Frame
Measures of safety. Measures of lung function	Up to Day 115

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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. doi: 10.1164/rccm.200704-588OC. Epub 2007 Aug 23.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2004
• Primary Completion (Actual): October 28, 2005
• Study Completion (Actual): October 28, 2005

Study Registration Dates

• First Submitted: January 4, 2006
• First Submitted That Met QC Criteria: January 5, 2006
• First Posted (Estimate): January 9, 2006

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: asthma; allergen challenge
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: INO102141