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Completed

NCT Number: NCT01370187

Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Cough Infections Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Wheezing

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, 79145-3388, Iran

About this study

All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

Montelukast 4mg daily for 2 months

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Official study title

Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2011
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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