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The Effect of Montelukast Treatment in Wheezy Infants

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00934713
First received: July 7, 2009
Last updated: NA
Last verified: October 2003
History: No changes posted
  Purpose

The study is designed to evaluate the efficacy of montelukast on symptom-free days in unselected group of very young children with wheeze and recurrent asthma like symptoms. The secondary aim was to evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue medication.


Condition Intervention Phase
Lung Disease, Obstructive
Signs and Symptoms, Respiratory
 Drug: montelukast
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • symptom free days [ Time Frame: 2 weeks runin and 8 weeks treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • lung function, airway responsiveness, exhale nitric oxide, use of rescue medication [ Time Frame: before and after 8 weeks treatment ] [ Designated as safety issue: Yes ]

Enrollment: 112
Study Start Date: September 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: montelukast
montelukast 4 mg once per day for 8 weeks
 Drug: montelukast
montelukast 4mg once per day for 8 weeks period
Other Name: singulair

Detailed Description:

The aim of this study was to investigate the effectiveness of montelukast in wheezy very young children with persistent respiratory symptoms. This study was a prospective, double-blind, placebo-controlled study of 6 to 24 months old children, who had at least one physician-diagnosed wheezing episode and persistent asthmatic symptoms. Patients were randomised to placebo or montelukast 4 mg / day for 8 weeks period. The clinical response to treatment was determined, the functional residual capacity (FRC) and specific air-way conductance (sGaw) was measured using an infant whole-body pletys-mograph, the maximal flow at functional residual capacity (V´maxFRC) was re-corded using the squeeze technique and airway responsiveness was evaluated by performing a dosimetric methacholine challenge test.

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least one physician-diagnosed wheezing episode and history of recurrent cough, dyspnoea and wheeze and successfully performed methacholine challenge test were included.

Exclusion Criteria:

  • use of ICS within 8 weeks prior to the first visit, a cumulative life-time systemic prednisolone use more than 3 days at a dose of 2 mg/kg, an equipotent dose of another systemic corticosteroid or ICS use more than 4 weeks, respiratory infection in the 14 days preceding lung function measurement and obvious tracheobronchomalacia or other structural defect.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934713

Locations
Finland
Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, P.O.Box 160, Finland, FIN-00029 HUS
Sponsors and Collaborators
Helsinki University
Merck
Investigators
Study Chair: Anna S Pelkonen, MD Helsinki University Central Hospital
  More Information

No publications provided by Helsinki University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pelkonen Anna, Helsinki University Central Hospital, P.O.Box 160, FIN-00029, Finland
ClinicalTrials.gov Identifier: NCT00934713     History of Changes
Other Study ID Numbers: 33902
Study First Received: July 7, 2009
Last Updated: July 7, 2009
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University:
montelukast, very young children, lung function tests

Additional relevant MeSH terms:
Lung Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Lung Diseases, Obstructive
Respiratory Tract Diseases
Montelukast
Leukotriene Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013