Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370187
• Other study ID #: Montelukast for bronchiolitis
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: June 13, 2011
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2010
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Cough
• Wheezing

Intervention

Drug:
• Montelukast
Montelukast 4mg daily for 2 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hormozgan University of Medical Sciences (HUMS)	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Distress Severity Score (RDSS)	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	participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	average number of cough daily= as expressed parents during visits	none= No cough, Mild=less than 10 daily, Severe=More than 10 daily	6 months	No
Secondary	Wheezing severity in the physical examination by physician	None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory	6 Months	No