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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03369119
Other study ID # B.10.0.IEG.0.11.00.01/003247
Secondary ID
Status Completed
Phase Phase 4
First received November 30, 2017
Last updated December 5, 2017
Start date August 2011
Est. completion date December 2012

Study information

Verified date December 2017
Source Kecioren Education and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group 6 Months to 60 Months
Eligibility 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)

Study Design


Intervention

Drug:
Montelukast 4 Mg Oral Granule

Placebos


Locations

Country Name City State
Turkey Kecioren Education and Training Hospital Ankara Keçiören

Sponsors (1)

Lead Sponsor Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Difference in clinical asthma score Improvement of clinical asthma scores between the 2 groups within 72 hours Within 72 hours from hospitalization
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