Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing | RxWiki

Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

Overview[ - collapse ][ - ]

Purpose	The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.
Condition	Bronchiolitis Wheezing Cough
Intervention	Drug: Montelukast
Phase	N/A
Sponsor	Hormozgan University of Medical Sciences
Responsible Party	Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier	NCT01370187
First Received	June 6, 2011
Last Updated	June 13, 2011
Last verified	June 2010

Tracking Information[ + expand ][ + ]

First Received Date	June 6, 2011
Last Updated Date	June 13, 2011
Start Date	July 2010
Estimated Primary Completion Date	June 2011
Current Primary Outcome Measures	Respiratory Distress Severity Score (RDSS) [Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days] [Designated as safety issue: No]RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores
Current Secondary Outcome Measures	average number of cough daily= as expressed parents during visits [Time Frame: 6 months] [Designated as safety issue: No]none= No cough, Mild=less than 10 daily, Severe=More than 10 daily Wheezing severity in the physical examination by physician [Time Frame: 6 Months] [Designated as safety issue: No]None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory

Descriptive Information[ + expand ][ + ]

Brief Title	Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
Official Title	Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital
Brief Summary	The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.
Detailed Description	All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Condition	Bronchiolitis Wheezing Cough
Intervention	Drug: Montelukast Montelukast 4mg daily for 2 months Other Names: Montelukast
Study Arm (s)	No Intervention: Control Control group Experimental: Montelukast 4mg Montelukast daily for 2 months

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	146
Estimated Completion Date	June 2011
Estimated Primary Completion Date	April 2011
Eligibility Criteria	Inclusion Criteria: - infant in 3-12 months of age with first episode of wheezing or bronchiolitis - written informed consent by parents Exclusion Criteria: - Previous wheezing episode or confirmed asthma or bronchiolitis - recent bronchodilator use - immune deficient - immunosuppressive drug use - croup or pneumonia diagnosis - loss of follow up
Gender	Both
Ages	3 Months
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Iran, Islamic Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01370187
Other Study ID Numbers	Montelukast for bronchiolitis
Has Data Monitoring Committee	Yes
Information Provided By	Hormozgan University of Medical Sciences
Study Sponsor	Hormozgan University of Medical Sciences
Collaborators	Not Provided
Investigators	Principal Investigator: Ali Asghar Parhiz, Resident Hormzgan University of Medical Sciences (HUMS)
Verification Date	June 2010

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