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Montelukast as a Controller of Atopic Syndrome (MONTAS)
This study has been completed.
First Received: November 15, 2007   No Changes Posted
Sponsors and Collaborators: Helsinki University
Funded by academic grant from Merck & Co, Inc.
Information provided by: Helsinki University
ClinicalTrials.gov Identifier: NCT00559546
  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 IV

MedlinePlus related topics: Asthma Eczema Hay Fever Pinkeye
Drug Information available for: Montelukast sodium Montelukast
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Montelukast as a Controller of Atopic Syndrome

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
1: Active Comparator
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
2: Active Comparator
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559546

Locations
Finland
Skin and Allergy Hospital, Helsinki University Hospital
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
Helsinki University
Funded by academic grant from Merck & Co, Inc.
Investigators
Principal Investigator: Tari Haahtela, Professor Skin and Allergy Hospital, Helsinki University Hospital
  More Information

No publications provided

Study ID Numbers: HUS7/E5/07
Study First Received: November 15, 2007
Last Updated: November 15, 2007
ClinicalTrials.gov Identifier: NCT00559546     History of Changes
Health Authority: Finland: National Agency for Medicines

Study placed in the following topic categories:
Dermatitis, Atopic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Rhinitis
Eczema
Hormones
Leukotriene Antagonists
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis
Otorhinolaryngologic Diseases
Conjunctivitis, Allergic
Skin Diseases
Eye Diseases
Anti-Asthmatic Agents
Asthma
Conjunctivitis
Conjunctival Diseases
Montelukast
Genetic Diseases, Inborn
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on May 07, 2009