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Montelukast as a Controller of Atopic Syndrome (MONTAS)

Primary Purpose

Seasonal Allergic Rhinitis, Allergic Conjunctivitis, Atopic Eczema

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
montelukast
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skin and Allergy Hospital, Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

3 weeks of Montelukast and 3 weeks of placebo treatment

3 weeks of placebo and 3 weeks of montelukast treatment

Outcomes

Primary Outcome Measures

Allergic symptoms

Secondary Outcome Measures

Need for antihistamines or inhaled beta-2-agonists to relieve symptoms
Exhaled nitric oxide concentration

Full Information

First Posted
November 15, 2007
Last Updated
November 15, 2007
Sponsor
University of Helsinki
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00559546
Brief Title
Montelukast as a Controller of Atopic Syndrome
Acronym
MONTAS
Official Title
Montelukast as a Controller of Atopic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Helsinki
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis, Allergic Conjunctivitis, Atopic Eczema, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
3 weeks of Montelukast and 3 weeks of placebo treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
3 weeks of placebo and 3 weeks of montelukast treatment
Intervention Type
Drug
Intervention Name(s)
montelukast
Intervention Description
10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
Primary Outcome Measure Information:
Title
Allergic symptoms
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Need for antihistamines or inhaled beta-2-agonists to relieve symptoms
Time Frame
3 weeks
Title
Exhaled nitric oxide concentration
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tari Haahtela, Professor
Organizational Affiliation
Skin and Allergy Hospital, Helsinki University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skin and Allergy Hospital, Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19127072
Citation
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.
Results Reference
derived

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Montelukast as a Controller of Atopic Syndrome

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