Last updated: 07/13/2020 16:30:04

Study With GW274150 In Patients With Mild Asthma

GSK study ID
INO102141
See study documents
Clinicaltrials.gov ID
NCT00273013
EudraCT ID
2004-000576-13
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Single centre Allergen challenge study of GW274150 in mild asthmatic subjects
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Effect on the late asthmatic reaction following an inhaled allergen challenge

Timeframe: Up to Day 115

Secondary outcomes:

Measures of safety. Measures of lung function

Timeframe: Up to Day 115

Interventions:
Drug: GW274150
Drug: Singulair
Drug: Placebo
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2005-28-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
GW274150
Collaborators
Not applicable
Study date(s)
November 2004 to October 2005
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
  • 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.
  • Recent steroid treatment.
  • Significant illnesses or diseases other than asthma.
Inclusion and exclusion criteria
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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
London, United Kingdom, SE1 9RT
Status
Study Complete
Contact us
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2005-28-10
Actual study completion date
2005-28-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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