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

Sponsor

Kecioren Education and Training Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01304901

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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

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 :

Apr 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

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 Names: Montelukast placebo granule

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 Names:

Montelukast placebo granule

Outcome Measures

Primary Outcome Measures

Difference of pulmonary index score from baseline to 120 minutes. [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

Proportion of discharge from emergency department. [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

Criteria

Ages Eligible for Study:

6 Months to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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