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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03369119
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Information provided by (Responsible Party):
Cem Hasan Razi, Kecioren Education and Training Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Asthma Acute Wheezy Bronchitis Drug: Montelukast 4 Mg Oral Granule Drug: Placebos Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Oral Montelukast Hospitalized Preschool Children
Actual Study Start Date : August 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arm Intervention/treatment
Active Comparator: Montelukast
Children received 4 mg oral montelukast granule daily until discharge.
Drug: Montelukast 4 Mg Oral Granule
Other Name: Montelukast sodium

Placebo Comparator: Placebo
Children receive 4 mg oral placebo montelukast granule daily until discharge
Drug: Placebos

Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: within the 5 days from hospitalization ]
    The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.

Secondary Outcome Measures :
  1. Difference in clinical asthma score [ Time Frame: Within 72 hours from hospitalization ]
    Improvement of clinical asthma scores between the 2 groups within 72 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03369119

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Kecioren Education and Training Hospital
Ankara, Keçiören, Turkey, 06380
Sponsors and Collaborators
Kecioren Education and Training Hospital
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Principal Investigator: Cem H. Razi, M.D. Pediatric Allergy Specialist

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Responsible Party: Cem Hasan Razi, Pediatric Allergy Specialist, Kecioren Education and Training Hospital Identifier: NCT03369119    
Other Study ID Numbers: B.10.0.İEG.
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cem Hasan Razi, Kecioren Education and Training Hospital:
Acute asthma
Hospitalized children
Preschool children
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Tract Infections
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action