Montelukast as a Controller of Atopic Syndrome

NCT ID: NCT00559546

Last Updated: 2007-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-07-31

Brief Summary

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The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis Allergic Conjunctivitis Atopic Eczema Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

3 weeks of Montelukast and 3 weeks of placebo treatment

Group Type ACTIVE_COMPARATOR

montelukast

Intervention Type DRUG

10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner

2

3 weeks of placebo and 3 weeks of montelukast treatment

Group Type ACTIVE_COMPARATOR

montelukast

Intervention Type DRUG

10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner

Interventions

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montelukast

10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Wheal diameter at least 4 mm in skin-prick test for both birch and timothy
* Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following:

* Allergic conjunctivitis
* Atopic eczema
* Oral symptoms from vegetables or fruits by cross reactivity to birch
* Urticaria in allergen exposure

Exclusion Criteria

* Need for regular treatment with glucocorticoids
* Current smoking
* Other major disease or need for regular drug treatment
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Principal Investigators

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Tari Haahtela, Professor

Role: PRINCIPAL_INVESTIGATOR

Skin and Allergy Hospital, Helsinki University Hospital

Locations

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Skin and Allergy Hospital, Helsinki University Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Lehtimaki L, Petays T, Haahtela T. Montelukast is not effective in controlling allergic symptoms outside the airways: a randomised double-blind placebo-controlled crossover study. Int Arch Allergy Immunol. 2009;149(2):150-3. doi: 10.1159/000189198. Epub 2009 Jan 6.

Reference Type DERIVED
PMID: 19127072 (View on PubMed)

Other Identifiers

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HUS7/E5/07

Identifier Type: -

Identifier Source: org_study_id