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Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children

Primary Purpose

Acute Asthma, Acute Wheezy Bronchitis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Montelukast 4 Mg Oral Granule
Placebos
Sponsored by
Kecioren Education and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Asthma focused on measuring Acute asthma, Montelukast, Hospitalized children, Preschool children

Eligibility Criteria

6 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Kecioren Education and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Montelukast

Placebo

Arm Description

Children received 4 mg oral montelukast granule daily until discharge.

Children receive 4 mg oral placebo montelukast granule daily until discharge

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in clinical asthma score
Improvement of clinical asthma scores between the 2 groups within 72 hours

Full Information

First Posted
November 30, 2017
Last Updated
December 5, 2017
Sponsor
Kecioren Education and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03369119
Brief Title
Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children
Official Title
Phase 4 Study of Oral Montelukast Hospitalized Preschool Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kecioren Education and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action. Objective: To evaluate the effect of the addition of a single dose of oral montelukast to standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel group trial. Setting: Pediatric service of Education and training Hospital Patients: Children with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical asthma score was recorded before administering study medication and thereafter, 4 hourly until discharge. Main outcome measure: The primary outcome was discharge rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Asthma, Acute Wheezy Bronchitis
Keywords
Acute asthma, Montelukast, Hospitalized children, Preschool children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montelukast
Arm Type
Active Comparator
Arm Description
Children received 4 mg oral montelukast granule daily until discharge.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Children receive 4 mg oral placebo montelukast granule daily until discharge
Intervention Type
Drug
Intervention Name(s)
Montelukast 4 Mg Oral Granule
Other Intervention Name(s)
Montelukast sodium
Intervention Type
Drug
Intervention Name(s)
Placebos
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.
Time Frame
within the 5 days from hospitalization
Secondary Outcome Measure Information:
Title
Difference in clinical asthma score
Description
Improvement of clinical asthma scores between the 2 groups within 72 hours
Time Frame
Within 72 hours from hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cem H. Razi, M.D.
Organizational Affiliation
Pediatric Allergy Specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kecioren Education and Training Hospital
City
Ankara
State/Province
Keçiören
ZIP/Postal Code
06380
Country
Turkey

12. IPD Sharing Statement

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Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children

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