- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01056692
OC000459 Bronchial Allergen Challenge
January 25, 2010 updated by: Oxagen Ltd
A Phase II Study of oc000459 in Subjects With Allergic Asthma; a Randomised, Double Blind, Two Way Balanced Crossover Comparing oc000459 With Placebo
OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma.
This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic response in the lungs, namely cat hair, pollen or house dust mite and methacholine.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SE5 9PJ
- King's College London School of Medicine
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Manchester, United Kingdom, M23 9LT
- Medicines Evaluation Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
- FEV1 >65% of predicted on at least two occasions at screening.
- At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
- No steroid usage in the past 12 weeks.
- Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
- Non smokers for a minimum of 6 months; less than 10 pack year history.
Exclusion Criteria:
- Respiratory tract pathology other than allergic asthma.
- Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
- Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Active compound
OC000459 orally
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Capsules twice daily for 15 days
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PLACEBO_COMPARATOR: Placebo
Placebo given orally
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Capsules twice daily for 15 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 3 and 10 hours after allergen challenge.
Time Frame: Primary outcome is measured after 15 days of treatment with active or placebo
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Primary outcome is measured after 15 days of treatment with active or placebo
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary biological activity endpoints include the diminution of the early asthmatic response to bronchial allergen challenge sputum eosinophilia, the methacholine PC20 after allergen challenge and exhaled NO pre- and post-allergen.
Time Frame: These measures are examined after 15 days of treatment with either active or placebo
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These measures are examined after 15 days of treatment with either active or placebo
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Singh, MD, Medicines Evaluation Unit, Manchester, UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Registration Dates
First Submitted
December 21, 2009
First Submitted That Met QC Criteria
January 25, 2010
First Posted (ESTIMATE)
January 26, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 26, 2010
Last Update Submitted That Met QC Criteria
January 25, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OC000459/004/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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