The Effect of Montelukast Treatment in Wheezy Infants (Montelukast)

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

Tracking Information

• First Submitted Date: July 7, 2009
• First Posted Date: July 8, 2009
• Last Update Posted Date: July 8, 2009
• Study Start Date: September 2004
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 7, 2009): symptom free days [ Time Frame: 2 weeks runin and 8 weeks treatment ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Montelukast Treatment in Wheezy Infants
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Lung Disease, Obstructive
• Signs and Symptoms, Respiratory

Intervention

Drug: montelukast

montelukast 4mg once per day for 8 weeks period

Other Name: singulair

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 7, 2009): 112
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2008
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 24 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT00934713
• Other Study ID Numbers: 33902
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: University of Helsinki
• Original Study Sponsor: Same as current
• Collaborators: Merck Sharp & Dohme LLC

Investigators

• Study Chair: Anna S Pelkonen, MD; Helsinki University Central Hospital

• PRS Account: University of Helsinki
• Verification Date: October 2003