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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304901
• Other study ID #: B.10.0.IEG-0.15-00-01/5181
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2011
• Last updated: December 17, 2011
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Kecioren Education and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Asthma
• Asthma

Intervention

Drug:
• montelukast 4 mg granule
Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
• Montelukast placebo granüle
Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.

Locations

Country	Name	City	State
Turkey	Kecioren Education and Training Hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of pulmonary index score from baseline to 120 minutes.	Improvment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.	0 to 120 minutes	No
Secondary	Proportion of discharge from emergency department.	Proportion of subjects who were discharged from emergency department at 120,180 and 240. minutes were compared between the montelukast and placebo groups.	120, 180 and 240. minutes	No