AsthmaPhase 2NCT01955512
Effect of Clopidogrel on Allergen Challenge in Asthma
A Phase 2 study testing Clopidogrel in people with Asthma, run by University of Southampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of asthma
- Step one of treatment by GINA (2006) guidelines
- baseline FEV1 >80% predicted
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton Faculty of Medicine
Southampton, Hampshire, SO16 6YD
About this study
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
- Being tested
- Clopidogrel, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Clopidogrel 75mg daily for 7 days
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Arm given placebo Receives: Drug: Placebo |
| Clopidogrel | Experimental | Group given clopidogrel Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel
Measured: 8 days
Secondary outcomes (7)
Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second
Measured: 8 days
Change in sputum tissue factor concentration following allergen challenge in the presence and absence of clopidogrel
Measured: 8 days
Change in sputum tissue factor inhibitor concentration following allergen challenge in the presence and absence of clopidogrel
Measured: 8 days
Change in sputum thrombin activatable finbrinolysis inhibitor concentration following allergen challenge in the presence and absence of clopidogrel
Measured: 8 days
Change in sputum P-selectin concentration following allergen challenge in the presence and absence of clopidogrel
Measured: 8 days
Change in peripheral blood eosinophil and platelet counts following allergen challenge in the presence and absence of clopidogrel
Measured: 8 days
Change in urine fibrin degradation products and leukotriene E4 following allergen challenge in the presence and absence of clopidogrel
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter H Howarth, MD, Principal investigator, Professor of MedicineChristopher L Grainge, PhD MD, Study director, Senior Lecturer in Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955512
- Sponsor's protocol ID
- RHMMED1063
- Status last verified
- May 2023
- First submitted
- 27 Sep 2013
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clopidogrel on Allergen Challenge in Asthma
- ClinicalTrials.gov ID
- NCT01955512
- Acronym / sponsor ID
- RHMMED1063
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboArm given placebo |
| Clopidogrel | Experimental | Drug: ClopidogrelGroup given clopidogrel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of asthma
- Step one of treatment by GINA (2006) guidelines
- baseline FEV1 >80% predicted
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelClopidogrel 75mg daily for 7 days | Drug | Clopidogrel |
| PlaceboMatched placebo | Drug | Placebo |
Primary outcome
Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel
Time frame: 8 days
7 secondary outcomes
Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second
Time frame: 8 days
Change in sputum tissue factor concentration following allergen challenge in the presence and absence of clopidogrel
Time frame: 8 days
Change in sputum tissue factor inhibitor concentration following allergen challenge in the presence and absence of clopidogrel
Time frame: 8 days
Change in sputum thrombin activatable finbrinolysis inhibitor concentration following allergen challenge in the presence and absence of clopidogrel
Time frame: 8 days
Change in sputum P-selectin concentration following allergen challenge in the presence and absence of clopidogrel
Time frame: 8 days
Change in peripheral blood eosinophil and platelet counts following allergen challenge in the presence and absence of clopidogrel
Time frame: 8 days
Change in urine fibrin degradation products and leukotriene E4 following allergen challenge in the presence and absence of clopidogrel
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter H Howarth, MD principal investigator
Professor of Medicine
Christopher L Grainge, PhD MD study director
Senior Lecturer in Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clopidogrel in people with Asthma, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.