Study With GW274150 In Patients With Mild Asthma

NCT00273013 | Completed Phase 1

• 1 other identifier: INO102141
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma

Keywords

asthma; allergen challenge

Outcome Measures

Primary Outcomes (1)

• Effect on the late asthmatic reaction following an inhaled allergen challenge

  Up to Day 115

Secondary Outcomes (1)

• Measures of safety. Measures of lung function

  Up to Day 115

Study Arms (6)

Sequence 1

EXPERIMENTAL

Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.

Drug: GW274150; Drug: Singulair; Drug: Placebo

Sequence 2

EXPERIMENTAL

Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.

Drug: GW274150; Drug: Singulair; Drug: Placebo

Sequence 3

EXPERIMENTAL

Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.

Drug: GW274150; Drug: Singulair; Drug: Placebo

Sequence 4

EXPERIMENTAL

Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.

Drug: GW274150; Drug: Singulair; Drug: Placebo

Sequence 5

EXPERIMENTAL

Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.

Drug: GW274150; Drug: Singulair; Drug: Placebo

Sequence 6

EXPERIMENTAL

Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.

Drug: GW274150; Drug: Singulair; Drug: Placebo

Interventions

GW274150 DRUG

GW274150 will be available as 30 mg white oval tablets.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Singulair DRUG

Singulair will be available as over encapsulated 10 mg orange tablets.

Also known as: GW274150

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Placebo DRUG

Matching placebo for Singulair and GW274150 will be available.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Manchester, Lancashire, M23 9LT, United Kingdom

Location

GSK Investigational Site

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 17717202 DERIVED

Related Links

• Results for study 102141 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Asthma

Interventions

GW 274150; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2006
• First Posted: January 9, 2006
• Study Start: November 15, 2004
• Primary Completion: October 28, 2005
• Study Completion: October 28, 2005
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

GB (2)