Effect of Clopidogrel on Allergen Challenge in Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Clopidogrel

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University of Southampton Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Arm given placebo	Drug: Placebo; Matched placebo
Experimental: Clopidogrel; Group given clopidogrel	Drug: Clopidogrel; Clopidogrel 75mg daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel	8 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southampton
• Investigators: Principal Investigator: Peter H Howarth, MD, Professor of Medicine; Study Director: Christopher L Grainge, PhD MD, Senior Lecturer in Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 27, 2013
• First Submitted That Met QC Criteria: September 27, 2013
• First Posted (Estimate): October 7, 2013

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: RHMMED1063