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Study With GW274150 In Patients With Mild Asthma

Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00273013
Enrollment
28
Registered
2006-01-09
Start date
2004-11-15
Completion date
2005-10-28
Last updated
2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, allergen challenge

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.

Interventions

GW274150 will be available as 30 mg white oval tablets.

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

DRUGPlacebo

Matching placebo for Singulair and GW274150 will be available.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Effect on the late asthmatic reaction following an inhaled allergen challengeUp to Day 115

Secondary

MeasureTime frame
Measures of safety. Measures of lung functionUp to Day 115

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026