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Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370187
First Posted: June 9, 2011
Last Update Posted: June 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hormozgan University of Medical Sciences
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    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 ]
    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 ]
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 6, 2011
First Posted: June 9, 2011
Last Update Posted: June 14, 2011
Last Verified: June 2010

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
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action