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Montelukast as a Controller of Atopic Syndrome (MONTAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00559546
First Posted: November 16, 2007
Last Update Posted: November 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Helsinki University
  Purpose
The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.

Condition Intervention Phase
Seasonal Allergic Rhinitis Allergic Conjunctivitis Atopic Eczema Asthma Drug: montelukast Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Montelukast as a Controller of Atopic Syndrome

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Allergic symptoms [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Need for antihistamines or inhaled beta-2-agonists to relieve symptoms [ Time Frame: 3 weeks ]
  • Exhaled nitric oxide concentration [ Time Frame: 3 weeks ]

Enrollment: 61
Study Start Date: March 2007
Study Completion Date: July 2007
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559546


Locations
Finland
Skin and Allergy Hospital, Helsinki University Hospital
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
Helsinki University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Tari Haahtela, Professor Skin and Allergy Hospital, Helsinki University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00559546     History of Changes
Other Study ID Numbers: HUS7/E5/07
First Submitted: November 15, 2007
First Posted: November 16, 2007
Last Update Posted: November 16, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Conjunctivitis
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Dermatitis, Atopic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers