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Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

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. Identifier: NCT01370187
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : June 14, 2011
Information provided by:
Hormozgan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Wheezing Cough Drug: Montelukast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
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
Study Start Date : July 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Montelukast

Arm Intervention/treatment
No Intervention: Control
Control group
Experimental: Montelukast
4mg Montelukast daily for 2 months
Drug: Montelukast
Montelukast 4mg daily for 2 months

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Wheezing severity in the physical examination by physician [ Time Frame: 6 Months ]
    None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01370187

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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
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Principal Investigator: Ali Asghar Parhiz, Resident Hormzgan University of Medical Sciences (HUMS)

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Responsible Party: Ali Asghar Parhiz, Hormozgan University of Medical Sciences (HUMS) Identifier: NCT01370187    
Other Study ID Numbers: Montelukast for bronchiolitis
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: June 2010
Keywords provided by Hormozgan University of Medical Sciences:
Postbronchiolitis wheezing
Additional relevant MeSH terms:
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Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms
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