Effect of Clopidogrel on Allergen Challenge in Asthma

NCT01955512 | Completed Phase 2

• 1 other identifier: RHMMED1063
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel

  8 days

Secondary Outcomes (7)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Arm given placebo

Drug: Placebo

Clopidogrel

EXPERIMENTAL

Group given clopidogrel

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Clopidogrel 75mg daily for 7 days

Clopidogrel

Placebo DRUG

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

University of Southampton Faculty of Medicine

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Peter H Howarth, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

• Christopher L Grainge, PhD MD

  Senior Lecturer in Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 7, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

GB (1)