Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
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| First Received Date ICMJE | July 17, 2006 | ||||||||
| Last Updated Date | February 23, 2010 | ||||||||
| Start Date ICMJE | September 2001 | ||||||||
| Primary Completion Date | October 2004 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Forced Expiratory Volume in One Second (FEV1) | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00353184 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years | ||||||||
| Official Title ICMJE | Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years | ||||||||
| Brief Summary | Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours. |
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| Detailed Description | We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12% greater FEV1 improvement in three hours than those receiving standard therapy alone. In this randomized double-blind placebo-controlled study, we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations (initial PEFR 40-70% predicted). Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol, nebulized ipratropium bromide, and oral corticosteroids. We measured FEV1 before study medication administration and hourly for three hours. We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Asthma | ||||||||
| Intervention ICMJE | Drug: Montelukast 5-mg orally added to standard therapy | ||||||||
| Study Arm (s) | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 27 | ||||||||
| Completion Date | February 2005 | ||||||||
| Primary Completion Date | October 2004 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Years to 14 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00353184 | ||||||||
| Other Study ID Numbers ICMJE | WUSM HSC #01-0464 | ||||||||
| Has Data Monitoring Committee | |||||||||
| Responsible Party | Kyle Nelson, Washington University | ||||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | February 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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