Text Size

Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

This study has been completed.
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01370187
First received: June 6, 2011
Last updated: June 13, 2011
Last verified: June 2010
History of Changes
  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 Intervention
Bronchiolitis
Wheezing
Cough
 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:

MedlinePlus related topics: Cough
U.S. FDA Resources

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
Other Name: Montelukast

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.

  Eligibility

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370187

Locations
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
Investigators
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)
ClinicalTrials.gov 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:
Bronchiolitis
Postbronchiolitis wheezing
Montelukast

Additional relevant MeSH terms:
Bronchiolitis
Respiratory Sounds
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013