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OpenTrials
Completed

NCT Number: NCT00273013

Study With GW274150 In Patients With Mild Asthma

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Manchester, Lancashire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW274150

Drug

GW274150 will be available as 30 mg white oval tablets.

Singulair

Drug

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

Other names: GW274150

Placebo

Drug

Matching placebo for Singulair and GW274150 will be available.

Primary outcomes

  1. Effect on the late asthmatic reaction following an inhaled allergen challenge

    Time frame: Up to Day 115

Secondary outcomes

  1. Measures of safety. Measures of lung function

    Time frame: Up to Day 115

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 9, 2006
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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