NCT01370187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
Last Updated

June 14, 2011

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

June 6, 2011

Last Update Submit

June 13, 2011

Conditions

BronchiolitisWheezingCough

Keywords

BronchiolitisPostbronchiolitis wheezingMontelukast

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • average number of cough daily= as expressed parents during visits

    6 months

  • Wheezing severity in the physical examination by physician

    6 Months

Study Arms (2)

Control

NO INTERVENTION

Control group

Montelukast

EXPERIMENTAL

4mg Montelukast daily for 2 months

Drug: Montelukast

Interventions

MontelukastDRUG

Montelukast 4mg daily for 2 months

Montelukast

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infant in 3-12 months of age with first episode of wheezing or bronchiolitis
  • written informed consent by parents

You may not qualify if:

  • Previous wheezing episode or confirmed asthma or bronchiolitis
  • recent bronchodilator use
  • immune deficient
  • immunosuppressive drug use
  • croup or pneumonia diagnosis
  • loss of follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, 79145-3388, Iran

Location

MeSH Terms

Conditions

BronchiolitisRespiratory SoundsCough

Interventions

montelukast

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration Disorders

Study Officials

  • Ali Asghar Parhiz, Resident

    Hormzgan University of Medical Sciences (HUMS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 9, 2011

Study Start

July 1, 2010

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

June 14, 2011

Record last verified: 2010-06

Locations

IR(1)