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

NCT01304901 | Completed Phase 4

• 1 other identifier: B.10.0.İEG-0.15-00-01/5181
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Acute Asthma

Keywords

Acute asthma; Children; Montelukast; Emergency room

Outcome Measures

Primary Outcomes (1)

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

  İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.

  0 to 120 minutes

Secondary Outcomes (1)

• Proportion of discharge from emergency department.

  120, 180 and 240. minutes

Study Arms (2)

1-Montelukast

ACTIVE COMPARATOR

Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.

Drug: montelukast 4 mg granule

2- Placebo

PLACEBO COMPARATOR

Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.

Drug: Montelukast placebo granüle

Interventions

montelukast 4 mg granule DRUG

Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.

1-Montelukast

Montelukast placebo granüle DRUG

Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.

Also known as: Montelukast placebo granule

2- Placebo

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kecioren Education and Training Hospital: lead

Study Sites (1)

Kecioren Education and Training Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma; Emergencies

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CEM H RAZİ, M.D.

  Kecioren Education and Training Hospital

  STUDY DIRECTOR

• ELİF YAĞLI ÇOLAKOĞLU, M.D.

  Kecioren Education and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 20, 2011

Record last verified: 2011-12

Locations

TU (1)