asthma MedDRA version: 16.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Clopidogrel
Product Name: clopidogrel
Pharmaceutical Form: Tablet
INN or Proposed INN: clopidogrel
CAS Number: 94188-84-8
Other descriptive name: methyl 2-(2-chlorophenyl)-2-(6,7-dihydro-
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Current smoker, ex-smoker who quit 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the influence of clopidogrel on the inflammation following inhaled allergen challenge in asthma to enable a better understanding of the underlying pathology of asthma, and to assess whether clopidogrel might become a useful treatment.;Secondary Objective: To identify potential markers reflective of the disease process in asthma that might be potentially usable as a biomarker that could aid in the diagnosis and management of disease. To measure speech and breathing patterns in asthma to see if these can aid diagnosis or monitoring of asthma.;Primary end point(s): Change in sputum eosinophil count after allergen challenge;Timepoint(s) of evaluation of this end point: 8 days after commencing 7 day course of clopidogrel | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second. Sputum concentrations of tissue factor, tissue factor inhibitor, thrombin activatable finbrinolysis inhibitor and P-selectin. Change in peripheral blood eosinophil and platelet counts. Change in urine fibrin degradation products and leukotriene E4.;Timepoint(s) of evaluation of this end point: 8 days after commencing 7 day course of clopidogrel | — |
Countries
United Kingdom
Contacts
Public ContactDr Christopher Grainge
University Hospital Southampton NHS Foundation Trust
Outcome results
None listed