Status:
COMPLETED
COX-2 Inhibition in Allergic Asthma
Lead Sponsor:
Barbro Dahlen
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The study is part of a research programme into mechanisms of asthmatic airway obstruction, focusing on the role of lipid mediators such as the prostaglandins. To this end the effect of a non-steroida...
Eligibility Criteria
Inclusion
- Female or male aged 18 to 55 years inclusive
- A history of asthma for at least 6 months with at least one of the following:
- response to standard asthma treatment
- episodic wheezing
- change in lung function over short periods of time
- A positive methacholine challenge test as evidenced by a PD20 ≤7256 µg cumulated dose within 8 weeks prior to screening or at the screening visit.
- Stable intermittent asthma, only using bronchodilator therapy as needed for the last 4 weeks.
- FEV1 ≥ 75% of predicted.
- A positive skin prick test to pollen (grass, birch, mugwort) or animal dander (dog, cat)
Exclusion
- Known or suspected hypersensitivity to coxibs
- Any significant respiratory disease other than asthma
- Respiratory tract infection within 4 weeks before inclusion.
- Any significant disease or disorder which, in the opinion of the investigator, may put the patient at risk because of participation in the study. In particular previous or present history of cardiovascular disease, ie myocardial infarction, stroke, severe hypertension, left ventricular heart failure and/or pulmonary hypertension are strict exclusion criteria.
- Current or former smoker within the last year and a smoking history of \>4 packyears
- Pregnancy/breastfeeding
- Use of:
- inhaled glucocorticosteroid treatment or use of oral corticosteroids for the last 8 weeks prior to inclusion or during the study.
- inhaled long-acting or oral beta2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within 2 weeks of screening or during the study.
- paracetamol, NSAIDs or any other antiinflammatory drugs the last 2 weeks prior to inclusion or during the study.
- need of any other regular drug treatment that may interfere with the study outcomes.
- BMI \>30 kg/m2.
- Use of any beta-blocking agent
- Any non-asthma-related, clinically significant abnormal finding in physical and/or vital signs, and/or in hematology or blood chemistry tests at visit 1, which in the opinion of the investigator, may put the patient at risk because of participation in the study.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01002690
Start Date
October 1 2009
End Date
April 1 2012
Last Update
April 24 2013
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, SE-141 86