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Montelukast as a Controller of Atopic Syndrome (MONTAS)

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00559546
First received: November 15, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Montelukast as a Controller of Atopic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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

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
Merck
Investigators
Principal Investigator: Tari Haahtela, Professor Skin and Allergy Hospital, Helsinki University Hospital
  More Information

No publications provided by Helsinki University

Additional 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
Study First Received: November 15, 2007
Last Updated: November 15, 2007
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Asthma
Conjunctivitis
Conjunctivitis, Allergic
Dermatitis, Atopic
Eczema
Rhinitis, Allergic, Seasonal
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung 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
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013