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Completed

NCT Number: NCT01955512

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Southampton Faculty of Medicine

Southampton, Hampshire, SO16 6YD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Clopidogrel 75mg daily for 7 days

Placebo

Drug

Matched placebo

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

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2013
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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