Montelukast as a Controller of Atopic Syndrome (MONTAS)

November 15, 2007 updated by: University of Helsinki
The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029 HUS
        • Skin and Allergy Hospital, Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
3 weeks of Montelukast and 3 weeks of placebo treatment
Drug: montelukast
10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
Active Comparator: 2
3 weeks of placebo and 3 weeks of montelukast treatment
Drug: montelukast
10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Allergic symptoms
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for antihistamines or inhaled beta-2-agonists to relieve symptoms
Time Frame: 3 weeks
3 weeks
Exhaled nitric oxide concentration
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Tari Haahtela, Professor, Skin and Allergy Hospital, Helsinki University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

November 16, 2007

Last Update Submitted That Met QC Criteria

November 15, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS7/E5/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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