The Effect of Montelukast Treatment in Wheezy Infants
Overview[ - collapse ][ - ]
| 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 | Lung Disease, Obstructive Signs and Symptoms, Respiratory |
| Intervention | Drug: montelukast |
| Phase | Phase 4 |
| Sponsor | Helsinki University |
| Responsible Party | Helsinki University |
| ClinicalTrials.gov Identifier | NCT00934713 |
| First Received | July 7, 2009 |
| Last Updated | July 7, 2009 |
| Last verified | October 2003 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 7, 2009 |
|---|---|
| Last Updated Date | July 7, 2009 |
| Start Date | September 2004 |
| Estimated Primary Completion Date | April 2008 |
| Current Primary Outcome Measures | symptom free days [Time Frame: 2 weeks runin and 8 weeks treatment] [Designated as safety issue: Yes] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| 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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: montelukast montelukast 4mg once per day for 8 weeks period Other Names: singulair |
| Study Arm (s) | Active Comparator: montelukast montelukast 4 mg once per day for 8 weeks |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 112 |
| Estimated Completion Date | April 2008 |
| Estimated Primary Completion Date | April 2008 |
| 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. |
| Gender | Both |
| Ages | 6 Months |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Finland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00934713 |
|---|---|
| Other Study ID Numbers | 33902 |
| Has Data Monitoring Committee | No |
| Information Provided By | Helsinki University |
| Study Sponsor | Helsinki University |
| Collaborators | Merck Sharp & Dohme Corp. |
| Investigators | Study Chair: Anna S Pelkonen, MD Helsinki University Central Hospital |
| Verification Date | October 2003 |
Locations[ + expand ][ + ]
| Skin and Allergy Hospital, Helsinki University Central Hospital | Helsinki, P.O.Box 160, Finland, FIN-00029 HUS |
|---|