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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cem Hasan Razi, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:
NCT01304901
First received: February 25, 2011
Last updated: December 17, 2011
Last verified: December 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014