NCT03369119

Brief Summary

Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations. The purpose of this study is to determine if adding oral montelukast to the maximal standard treatment in children hospitalized for acute asthma has any additive benefit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

November 30, 2017

Last Update Submit

December 5, 2017

Conditions

Acute AsthmaAcute Wheezy Bronchitis

Keywords

Acute asthmaMontelukastHospitalized childrenPreschool children

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.

    within the 5 days from hospitalization

Secondary Outcomes (1)

  • Difference in clinical asthma score

    Within 72 hours from hospitalization

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

Children received 4 mg oral montelukast granule daily until discharge.

Drug: Montelukast 4 Mg Oral Granule

Placebo

PLACEBO COMPARATOR

Children receive 4 mg oral placebo montelukast granule daily until discharge

Drug: Placebos

Interventions

Montelukast 4 Mg Oral GranuleDRUG
Also known as: Montelukast sodium
Montelukast
PlacebosDRUG
Placebo

Eligibility Criteria

Age6 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Medical history of at least 4 wheezing attacks
  • Children with the ages of 6-60 months
  • Children whose parents accept to give written informed consent

You may not qualify if:

  • Chronic diseases (e.g. malnutrition, anatomic malformation of the respiratory tract, chronic lung or heart disease, gastroesophageal reflux disease and cystic fibrosis)
  • Children with a history of chronic drug use (e.g. antiepileptics and immune suppressives)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kecioren Education and Training Hospital

Ankara, Keçiören, 06380, Turkey (Türkiye)

Location

MeSH Terms

Interventions

montelukast

Study Officials

  • Cem H. Razi, M.D.

    Pediatric Allergy Specialist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Allergy Specialist

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 11, 2017

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

December 11, 2017

Record last verified: 2017-12

Locations

TU(1)