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CompletedNCT01955512Updated May 22, 2023

Effect of Clopidogrel on Allergen Challenge in Asthma

A Phase 2 interventional study of Clopidogrel and Placebo in Asthma, sponsored by University of Southampton. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-05-22.

Sponsored by University of Southampton · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study 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.

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Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 24 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

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Lead sponsor

University of Southampton is the lead sponsor of 121 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Arm given placebo

    Drug: Placebo

  • Experimental
    Clopidogrel

    Group given clopidogrel

    Drug: Clopidogrel

Interventions

  • DrugClopidogrel

    Clopidogrel 75mg daily for 7 days

  • DrugPlacebo

    Matched placebo

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What researchers measure

Primary outcomes

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

    Time frame: 8 days

Secondary outcomes

  1. Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second

    Time frame: 8 days

  2. Change in sputum tissue factor concentration following allergen challenge in the presence and absence of clopidogrel

    Time frame: 8 days

  3. Change in sputum tissue factor inhibitor concentration following allergen challenge in the presence and absence of clopidogrel

    Time frame: 8 days

  4. Change in sputum thrombin activatable finbrinolysis inhibitor concentration following allergen challenge in the presence and absence of clopidogrel

    Time frame: 8 days

  5. Change in sputum P-selectin concentration following allergen challenge in the presence and absence of clopidogrel

    Time frame: 8 days

  6. Change in peripheral blood eosinophil and platelet counts following allergen challenge in the presence and absence of clopidogrel

    Time frame: 8 days

  7. Change in urine fibrin degradation products and leukotriene E4 following allergen challenge in the presence and absence of clopidogrel

    Time frame: 8 days

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01955512
Lead sponsor
University of Southampton
Responsible party
Sponsor
First posted
Oct 7, 2013
Start date
May 2013
Primary completion
May 2014
Completion
May 2014
Last update
May 22, 2023

Study contacts

Peter H Howarth, MD
principal investigator · Professor of Medicine
Christopher L Grainge, PhD MD
study director · Senior Lecturer in Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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