COX-2 Inhibition in Allergic Asthma

NCT01002690 | Completed DMC

• 1 other identifier: COX2EAR090531
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Allergen challenge; Airway responsiveness; Prostaglandins; Eicosanoids

Outcome Measures

Primary Outcomes (1)

• Allergen PD20 FEV1

  10 to 13 days

Secondary Outcomes (1)

• Urinary prostaglandin E2 and D2 concentrations

  10-13 days

Study Arms (1)

Etoricoxib

EXPERIMENTAL

10-13 days treatment with etoricoxib

Drug: Etoricoxib

Interventions

Etoricoxib DRUG

90 mg/day orally for 10-13 days

Also known as: Arcoxia

Etoricoxib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Known or suspected hypersensitivity to coxibs
• Any significant respiratory disease other than asthma
• Current or former smoker within the last year and a smoking history of \>4 packyears
• Pregnancy/breastfeeding
• Use of:
• inhaled long-acting or oral beta2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within 2 weeks of screening 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.

Sponsors & Collaborators

• Barbro Dahlen: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, SE-141 86, Sweden

Location

MeSH Terms

Conditions

Asthma

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Barbro Dahlén, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

SE (1)