A study to assess disease pathology and key therapeutic targets in severe asthma

• Conditions: Mild to severe persistent asthma.

• Registration Number: EUCTR2004-002873-21-GB
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-15
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male or female subject aged between 18-65 years inclusive at screening.
2. Have a history of mild to severe persistent asthma that must be documented for a minimum of 6 months prior to entry to the study, with exclusion of other significant pulmonary diseases.
3. A female subject of childbearing potential must be using effective contraceptive measures, as defined in POL/GMO/003:
4. Body mass index within the range 19-31 kg.m-2
5. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study.
2. The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
3. Subject is female who is pregnant or lactating.
4. Currently or planning to take during the study regular medication (including over-the-counter) except for medication allowed in inclusion criteria.
5. Having participated within 30 days or 5 half-lives, whichever is longer of the first dose in a study using new molecular entity, or the first dose in any other study investigating drugs or having participated within one month of the first dose in a study with invasive procedures.
6. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments.
7. History of abnormal bruising or bleeding.
8. Female subjects who are unwilling or unable to use an appropriate method of contraception
9. Concomitant medications that may interfere with study procedures or evaluations. Examples include:
Anticoagulants except low dose of Aspirin (80 mg per day) (for bronchoscopy)
Beta blockers except for low dose Atenolol (25 mg/day) or Metoprolol (50 mg/day) (for bronchoscopy)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified