Status:
UNKNOWN
A Mechanistic Study to Evaluate the Efficacy of Montelukast on Airway Function in Asthma
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The trial is an investigator-driven research study in subjects with intermittent asthma, the aim of which is to explore the likelihood of a functionally important separate leukotriene E4 (LTE4) recept...
Detailed Description
Rationale: It has been proposed that there is a specific LTE4-receptor which causes infiltration of inflammatory cells and bronchoconstriction. This receptor is not blocked by the current class of cli...
Eligibility Criteria
Inclusion
- Be aged 18-55 years inclusive
- Have a diagnosed history of asthma as defined by at least one of the following:
- response to standard asthma treatment
- episodic wheezing
- change in lung function over short periods of time
- Be a non-smoker for the last two years and a total of smoking less than 5 pack-years
- Display a positive methacholine challenge test as evidenced by a PD20 (provocative dose causing 20% fall in forced expiratory volume in one second) ≤ 3621 µg cumulated dose within 8 weeks prior to screening or at the screening visit.
- Have stable intermittent asthma, only using bronchodilator therapy as needed for the last 4 weeks.
- Produce FEV1 (forced expiratory volume in one second) ≥ 70 % of predicted
- \-
Exclusion
- Any significant respiratory disease, other than asthma.
- Subjects with seasonal asthma may not be included if they are in their season.
- Use of:
- oral or inhaled glucocorticosteroid treatment for the last 4 weeks prior to inclusion or during the study
- inhaled long-acting or oral beta2-agonists, anticholinergic bronchodilators, antihistamines, theophyllines, chromones and antileukotrienes within 2 weeks of screening
- regular NSAIDs
- drugs that inhibit the enzyme CYP3A (e.g. ritonavir, azol, antifungals, macrolides)
- beta-blocking agents
- Upper or lower respiratory tract infection within 4 weeks before inclusion
- Evidence (from medical history or physical examination) of any disease that in the investigators mind would affect the results of the study, in particular liver disease and/or signs of liver function impairment
- Participating in another study in the four weeks prior to screening
- Females who are pregnant, intend to be or who are lactating
- Subjects with history of aspirin-sensitive respiratory disease
- \-
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01841164
Start Date
May 1 2012
End Date
December 1 2014
Last Update
April 26 2013
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, SE -141 86