Proof of concept trial of the role of clopidogrel in preventing allergen induced inflammation in asthma

• Conditions: asthma; MedDRA version: 16.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2012-003698-25-GB
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-30
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Confirmed diagnosis of asthma
Only taking as required short acting beta agonists as treatment
Baseline forced expiratory volume in one second (FEV1)>80% predicted
Age 18-50 years
For female patients: menopausal >2yr or with childbearing potential but taking efficient contraception and having a negative pregnancy test.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Current smoker, ex-smoker who quit <1yr prior to study and smoking history >10 pack years
Current use of aspirin, selective serotonin reuptake inhibitors, any other anticoagulant medication, or medication which interacts adversely with clopidogrel
Diagnosis or documented history of bronchopulmonary aspergillosis or uncontrolled infections
Any clinically significant cardiopulmonary abnormalities not related to pre-existing asthma
Past or present tuberculosis, systemic lupus erythematosis or multiple sclerosis
Any clinically significant neurological, renal, endocrine, gastrointestinal, hepatic or haematological abnormalities uncontrolled with standard treatment
History of psychiatric, medical or surgical disorders that may interfere with study
Clinical history suggestive of respiratory infection in month preceding study
Alcohol or recreational drug abuse
Diagnosis of immunodeficiency requiring treatment
Treatment with immunomodulators (inhaled corticosteroids in two months or oral corticosteroids in six months prior to study)
Ongoing allergen desensitisation therapy
Regular use of sedatives, hypnotics, tranquillisers
Positive hepatitis viral antigens or antibodies
Blood donation within 3 months of the study
Live immunisation <4 wks prior to study
Inability to understand directions for study assessment
Inability to be contacted in case of emergency
Participation in another study at the same time or within a prior 3-month period

Study & Design

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