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Study With GW274150 In Patients With Mild Asthma

NCT ID: NCT00273013

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-15

Study Completion Date

2005-10-28

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma allergen challenge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Study Groups

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Sequence 1

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

Group Type EXPERIMENTAL

GW274150

Intervention Type DRUG

GW274150 will be available as 30 mg white oval tablets.

Singulair

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Matching placebo for Singulair and GW274150 will be available.

Sequence 2

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

Group Type EXPERIMENTAL

GW274150

Intervention Type DRUG

GW274150 will be available as 30 mg white oval tablets.

Singulair

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Matching placebo for Singulair and GW274150 will be available.

Sequence 3

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

Group Type EXPERIMENTAL

GW274150

Intervention Type DRUG

GW274150 will be available as 30 mg white oval tablets.

Singulair

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Matching placebo for Singulair and GW274150 will be available.

Sequence 4

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

Group Type EXPERIMENTAL

GW274150

Intervention Type DRUG

GW274150 will be available as 30 mg white oval tablets.

Singulair

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Matching placebo for Singulair and GW274150 will be available.

Sequence 5

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

Group Type EXPERIMENTAL

GW274150

Intervention Type DRUG

GW274150 will be available as 30 mg white oval tablets.

Singulair

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Matching placebo for Singulair and GW274150 will be available.

Sequence 6

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

Group Type EXPERIMENTAL

GW274150

Intervention Type DRUG

GW274150 will be available as 30 mg white oval tablets.

Singulair

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Matching placebo for Singulair and GW274150 will be available.

Interventions

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GW274150

GW274150 will be available as 30 mg white oval tablets.

Intervention Type DRUG

Singulair

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

Intervention Type DRUG

Placebo

Matching placebo for Singulair and GW274150 will be available.

Intervention Type DRUG

Other Intervention Names

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GW274150

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Manchester, Lancashire, United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 17717202 (View on PubMed)

Other Identifiers

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INO102141

Identifier Type: -

Identifier Source: org_study_id