Back to resultsCOX-2 Inhibition in Allergic Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Etoricoxib
Sponsored by
About this trial
This is an interventional basic science trial for Asthma focused on measuring Asthma, Allergen challenge, Airway responsiveness, Prostaglandins, Eicosanoids
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etoricoxib
Arm Description
10-13 days treatment with etoricoxib
Outcomes
Primary Outcome Measures
Allergen PD20 FEV1
Secondary Outcome Measures
Urinary prostaglandin E2 and D2 concentrations
Full Information
NCT ID
NCT01002690
First Posted
October 26, 2009
Last Updated
April 23, 2013
Sponsor
Barbro Dahlen
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT01002690
Brief Title
COX-2 Inhibition in Allergic Asthma
Official Title
Effect of COX-2 Inhibition on Allergen-induced Airway Obstruction in Subjects With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barbro Dahlen
Collaborators
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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-steroidal anti-inflammatory drug, the selective COX-2 inhibitor etoricoxib, will be evaluated in the allergen challenge setting in twelve subjects with intermittent allergic asthma. Active treatment for 10 to 13 days will be compared with an identical study period with no treatment in a cross-over, randomised design. Rising dose allergen challenges will be performed on three occasions to assess possible changes in airways responsiveness. Sampling of blood, urine, saliva and sputum will be done to allow for analyses of the production of prostaglandins and other lipid mediators, of the efficacy of COX-2 inhibition as well as of regulation of immune cells.
It is hypothesized that inhibition of COX-2 by virtue of inhibition of bronchoprotective prostaglandin E2 leads to a slightly exaggerated airway response to allergen exposure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Allergen challenge, Airway responsiveness, Prostaglandins, Eicosanoids
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etoricoxib
Arm Type
Experimental
Arm Description
10-13 days treatment with etoricoxib
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Other Intervention Name(s)
Arcoxia
Intervention Description
90 mg/day orally for 10-13 days
Primary Outcome Measure Information:
Title
Allergen PD20 FEV1
Time Frame
10 to 13 days
Secondary Outcome Measure Information:
Title
Urinary prostaglandin E2 and D2 concentrations
Time Frame
10-13 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbro Dahlén, MD PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
12. IPD Sharing Statement
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COX-2 Inhibition in Allergic Asthma
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