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

Purpose

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	Intervention	Phase
Asthma Acute Asthma	Drug: montelukast 4 mg granule Drug: Montelukast placebo granüle	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids Toddler Health

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Kecioren Education and Training Hospital:

Primary Outcome Measures:

Difference of pulmonary index score from baseline to 120 minutes. [ Time Frame: 0 to 120 minutes ] [ Designated as safety issue: No ]
İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.

Secondary Outcome Measures:

Proportion of discharge from emergency department. [ Time Frame: 120, 180 and 240. minutes ] [ Designated as safety issue: No ]
Proportion of subjects who were discharged from emergency department at 120,180 and 240. minutes were compared between the montelukast and placebo groups.

Enrollment:	80
Study Start Date:	April 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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. Other Name: montelukast 4 mg granule
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

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.

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	February 25, 2011
Last Updated:	December 17, 2011
Health Authority:	Turkey: Ethics Committee Turkey: Ministry of Health

Keywords provided by 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
Glucocorticoids

Montelukast
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013