Montelukast as a Controller of Atopic Syndrome

Overview[ - collapse ][ - ]

Purpose The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.
ConditionSeasonal Allergic Rhinitis
Allergic Conjunctivitis
Atopic Eczema
Asthma
InterventionDrug: montelukast
PhasePhase 4
SponsorHelsinki University
Responsible PartyHelsinki University
ClinicalTrials.gov IdentifierNCT00559546
First ReceivedNovember 15, 2007
Last UpdatedNovember 15, 2007
Last verifiedNovember 2007

Tracking Information[ + expand ][ + ]

First Received DateNovember 15, 2007
Last Updated DateNovember 15, 2007
Start DateMarch 2007
Estimated Primary Completion DateJuly 2007
Current Primary Outcome MeasuresAllergic symptoms [Time Frame: 3 weeks]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleMontelukast as a Controller of Atopic Syndrome
Official TitleMontelukast as a Controller of Atopic Syndrome
Brief Summary
The purpose of the study is to find out if montelukast can be used to treat the various
symptoms of allergic syndrome.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Condition
  • Seasonal Allergic Rhinitis
  • Allergic Conjunctivitis
  • Atopic Eczema
  • Asthma
InterventionDrug: montelukast
10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
Study Arm (s)
  • Active Comparator: 1
    3 weeks of Montelukast and 3 weeks of placebo treatment
  • Active Comparator: 2
    3 weeks of placebo and 3 weeks of montelukast treatment

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment61
Estimated Completion DateJuly 2007
Estimated Primary Completion DateNot Provided
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesFinland

Administrative Information[ + expand ][ + ]

NCT Number NCT00559546
Other Study ID NumbersHUS7/E5/07
Has Data Monitoring CommitteeNo
Information Provided ByHelsinki University
Study SponsorHelsinki University
CollaboratorsMerck Sharp & Dohme Corp.
Investigators Principal Investigator: Tari Haahtela, Professor Skin and Allergy Hospital, Helsinki University Hospital
Verification DateNovember 2007

Locations[ + expand ][ + ]

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