Montelukast in Children With Wheezing

Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years

In this study children with recurrent wheezing (>/= 2 episodes in the last 6 months)and aged less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.

Study Overview

• Status: Unknown
• Conditions: Wheezing
• Intervention / Treatment: Drug: Montelukast; Drug: Montelukast

Detailed Description

Patients aged less than 2 years with recurrent wheezing. At visit 1 patients with symptoms will be enrolled and the study explained. They will return home with bronchodilator therapy.

Within 1 week they will return for visit 2 to start a run-in period with bronchodilators prn and they will fill dairies with symptoms and drug use. Skin prick test will be evaluated at that time.

At visit 3 after 1 week of the run-in period they will start therapy with Montelukast 4 mg for 4 weeks, using bronchodilators prn and filling diaries.

The final visit will be after four weeks with re-evaluation of the lung function

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • Clinica Pediatrica Universita' di Verona Policlinico GB Rossi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 6-24 months
• Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
• Patients with symptoms at enrollment

Exclusion Criteria:

• Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Montelukast; the single arm will receive montelukast	Drug: Montelukast; the arm will be treated with Montelukast 4 mg die for 4 weeks; Other Names: antileukotrienes; Drug: Montelukast; montelukast 4 mg day for 4 weeks; Other Names: antileukotrienes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung function test (flow and resistance)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Bronchodilator use Dairy symptoms	4 weeks

Collaborators and Investigators

• Sponsor: Universita di Verona
• Collaborators: Azienda Ospedaliera Universitaria Policlinico
• Investigators: Principal Investigator: Attilio L Boner, MD, Universita di Verona

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 17, 2008
• First Submitted That Met QC Criteria: October 17, 2008
• First Posted (Estimate): October 20, 2008

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: lung function; children; wheezing; bronchodilators; montelukast; Rint
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast; Leukotriene Antagonists
• Other Study ID Numbers: AABB1948