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The Effect of Montelukast Treatment in Wheezy Infants (Montelukast)

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.
 
ClinicalTrials.gov Identifier: NCT00934713
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by:
University of Helsinki

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 8, 2009
Last Update Posted Date July 8, 2009
Study Start Date  ICMJE September 2004
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
symptom free days [ Time Frame: 2 weeks runin and 8 weeks treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
lung function, airway responsiveness, exhale nitric oxide, use of rescue medication [ Time Frame: before and after 8 weeks treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Montelukast Treatment in Wheezy Infants
Official Title  ICMJE The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Disease, Obstructive
  • Signs and Symptoms, Respiratory
Intervention  ICMJE Drug: montelukast
montelukast 4mg once per day for 8 weeks period
Other Name: singulair
Study Arms  ICMJE Active Comparator: montelukast
montelukast 4 mg once per day for 8 weeks
Intervention: Drug: montelukast
Publications * Pelkonen AS, Malmstrom K, Sarna S, Kajosaari M, Klemola T, Malmberg LP, Makela MJ. The effect of montelukast on respiratory symptoms and lung function in wheezy infants. Eur Respir J. 2013 Mar;41(3):664-70. doi: 10.1183/09031936.00173411. Epub 2012 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2009)
112
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00934713
Other Study ID Numbers  ICMJE 33902
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pelkonen Anna, Helsinki University Central Hospital, P.O.Box 160, FIN-00029, Finland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Helsinki
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE
Study Chair: Anna S Pelkonen, MD Helsinki University Central Hospital
PRS Account University of Helsinki
Verification Date October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP