Effect of Clopidogrel on Allergen Challenge in Asthma

Asthma Clinical Trial

Official title:

Effect of Clopidogrel on Allergen Challenge in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955512
• Other study ID #: RHMMED1063
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2023
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Clopidogrel
Clopidogrel 75mg daily for 7 days
• Placebo
Matched placebo

Locations

Country	Name	City	State
United Kingdom	University of Southampton Faculty of Medicine	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel		8 days
Secondary	Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second		8 days
Secondary	Change in sputum tissue factor concentration following allergen challenge in the presence and absence of clopidogrel		8 days
Secondary	Change in sputum tissue factor inhibitor concentration following allergen challenge in the presence and absence of clopidogrel		8 days
Secondary	Change in sputum thrombin activatable finbrinolysis inhibitor concentration following allergen challenge in the presence and absence of clopidogrel		8 days
Secondary	Change in sputum P-selectin concentration following allergen challenge in the presence and absence of clopidogrel		8 days
Secondary	Change in peripheral blood eosinophil and platelet counts following allergen challenge in the presence and absence of clopidogrel		8 days
Secondary	Change in urine fibrin degradation products and leukotriene E4 following allergen challenge in the presence and absence of clopidogrel		8 days