Clinical trial NCT01955512: Effect of Clopidogrel on Allergen Challenge in Asthma
Official title: Effect of Clopidogrel on Allergen Challenge in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In asthma, breathing in an allergen, such as house dust mite induces inflammation in the airways. This process appears to involve an interaction between two different sorts of blood cells, platelets and white blood cells via a receptor called the P2Y12 receptor. The purpose of this study is to determine whether the drug clopidogrel which blocks the P2Y12 receptor on platelets, reduces inflammation following breathing in house dust mite in people with mild asthma.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of asthma
* Step one of treatment by GINA (2006) guidelines
* baseline FEV1 \>80% predicted

Exclusion Criteria:

* current smoker
* ex smoker who quit \<1 year prior to study and pack history \>10 pack years
* current use of aspirin or other anticoagulant medication
* 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

Primary outcomes:
measure: Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel
timeFrame: 8 days
Secondary outcomes:
measure: Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second
timeFrame: 8 days
measure: Change in sputum tissue factor concentration following allergen challenge in the presence and absence of clopidogrel
timeFrame: 8 days
measure: Change in sputum tissue factor inhibitor concentration following allergen challenge in the presence and absence of clopidogrel
timeFrame: 8 days
measure: Change in sputum thrombin activatable finbrinolysis inhibitor concentration following allergen challenge in the presence and absence of clopidogrel
timeFrame: 8 days
measure: Change in sputum P-selectin concentration following allergen challenge in the presence and absence of clopidogrel
timeFrame: 8 days
measure: Change in peripheral blood eosinophil and platelet counts following allergen challenge in the presence and absence of clopidogrel
timeFrame: 8 days
measure: Change in urine fibrin degradation products and leukotriene E4 following allergen challenge in the presence and absence of clopidogrel
timeFrame: 8 days
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton Faculty of Medicine
state: Hampshire
Study officials:
affiliation: Professor of Medicine
name: Peter H Howarth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Lecturer in Medicine
name: Christopher L Grainge, PhD MD
role: STUDY_DIRECTOR
References: