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Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.

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ClinicalTrials.gov Identifier: NCT01304901
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : December 20, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.

Condition or disease Intervention/treatment Phase
Asthma Acute Asthma Drug: montelukast 4 mg granule Drug: Montelukast placebo granüle Phase 4

Detailed Description:

Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.

The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.
Study Start Date : April 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1-Montelukast
Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
Drug: montelukast 4 mg granule
Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
Placebo Comparator: 2- Placebo
Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
Drug: Montelukast placebo granüle
Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
Other Name: Montelukast placebo granule


Outcome Measures

Primary Outcome Measures :
  1. Difference of pulmonary index score from baseline to 120 minutes. [ Time Frame: 0 to 120 minutes ]
    İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.


Secondary Outcome Measures :
  1. Proportion of discharge from emergency department. [ Time Frame: 120, 180 and 240. minutes ]
    Proportion of subjects who were discharged from emergency department at 120,180 and 240. minutes were compared between the montelukast and placebo groups.


Eligibility Criteria

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months to 6 years of age
  • With at least three episodes of wheezing in the previous 12 months
  • Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score [PIS] of 7 to 13

Exclusion Criteria:

  • Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
  • Who had any change in their dose of ICSs in the past 2 months
  • Who had taken systemic corticosteroid within 1 months
  • Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01304901


Locations
Turkey
Kecioren Education and Training Hospital
Ankara, Keçiören, Turkey, 06290
Sponsors and Collaborators
Kecioren Education and Training Hospital
Investigators
Study Director: CEM H RAZİ, M.D. Kecioren Education and Training Hospital
Principal Investigator: ELİF YAĞLI ÇOLAKOĞLU, M.D. Kecioren Education and Training Hospital
More Information

Responsible Party: Cem Hasan Razi, MD, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier: NCT01304901     History of Changes
Other Study ID Numbers: B.10.0.İEG-0.15-00-01/5181
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by Cem Hasan Razi, Kecioren Education and Training Hospital:
Acute asthma
Children
Montelukast
Emergency room

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Albuterol
Glucocorticoids
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents