Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

This study has been completed.
Information provided by:
Hormozgan University of Medical Sciences Identifier:
First received: June 6, 2011
Last updated: June 13, 2011
Last verified: June 2010
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 Intervention
Drug: Montelukast

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital

Resource links provided by NLM:

Further study details as provided by Hormozgan University of Medical Sciences:

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

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

Enrollment: 146
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Control group
Experimental: Montelukast
4mg Montelukast daily for 2 months
Drug: Montelukast
Montelukast 4mg daily for 2 months

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.

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01370187

Iran, Islamic Republic of
Hormozgan University of Medical Sciences (HUMS)
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79145-3388
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Principal Investigator: Ali Asghar Parhiz, Resident Hormzgan University of Medical Sciences (HUMS)
  More Information

No publications provided

Responsible Party: Ali Asghar Parhiz, Hormozgan University of Medical Sciences (HUMS) Identifier: NCT01370187     History of Changes
Other Study ID Numbers: Montelukast for bronchiolitis 
Study First Received: June 6, 2011
Last Updated: June 13, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Postbronchiolitis wheezing

Additional relevant MeSH terms:
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on February 04, 2016