Clinical trial NCT01304901: Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Acute Asthma
Keywords: Acute asthma
Children
Montelukast
Emergency room
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Difference of pulmonary index score from baseline to 120 minutes.
timeFrame: 0 to 120 minutes
Secondary outcomes:
measure: Proportion of discharge from emergency department.
timeFrame: 120, 180 and 240. minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kecioren Education and Training Hospital
state: Keçiören
Study officials:
affiliation: Kecioren Education and Training Hospital
name: CEM H RAZİ, M.D.
role: STUDY_DIRECTOR
affiliation: Kecioren Education and Training Hospital
name: ELİF YAĞLI ÇOLAKOĞLU, M.D.
role: PRINCIPAL_INVESTIGATOR
References: