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Effect of Clopidogrel on Allergen Challenge in Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Clopidogrel
Placebo
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southampton Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Clopidogrel

Arm Description

Arm given placebo

Group given clopidogrel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2013
Last Updated
May 19, 2023
Sponsor
University of Southampton
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1. Study Identification

Unique Protocol Identification Number
NCT01955512
Brief Title
Effect of Clopidogrel on Allergen Challenge in Asthma
Official Title
Effect of Clopidogrel on Allergen Challenge in Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm given placebo
Arm Title
Clopidogrel
Arm Type
Experimental
Arm Description
Group given clopidogrel
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel 75mg daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo
Primary Outcome Measure Information:
Title
Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second
Time Frame
8 days
Title
Change in sputum tissue factor concentration following allergen challenge in the presence and absence of clopidogrel
Time Frame
8 days
Title
Change in sputum tissue factor inhibitor concentration following allergen challenge in the presence and absence of clopidogrel
Time Frame
8 days
Title
Change in sputum thrombin activatable finbrinolysis inhibitor concentration following allergen challenge in the presence and absence of clopidogrel
Time Frame
8 days
Title
Change in sputum P-selectin concentration following allergen challenge in the presence and absence of clopidogrel
Time Frame
8 days
Title
Change in peripheral blood eosinophil and platelet counts following allergen challenge in the presence and absence of clopidogrel
Time Frame
8 days
Title
Change in urine fibrin degradation products and leukotriene E4 following allergen challenge in the presence and absence of clopidogrel
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H Howarth, MD
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher L Grainge, PhD MD
Organizational Affiliation
Senior Lecturer in Medicine
Official's Role
Study Director
Facility Information:
Facility Name
University of Southampton Faculty of Medicine
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

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Effect of Clopidogrel on Allergen Challenge in Asthma

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