Montelukast in Children With Wheezing

NCT ID: NCT00775697

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

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

Conditions

Wheezing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Montelukast

the single arm will receive montelukast

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

the arm will be treated with Montelukast 4 mg die for 4 weeks

Montelukast

Intervention Type: DRUG

montelukast 4 mg day for 4 weeks

Interventions

Montelukast

the arm will be treated with Montelukast 4 mg die for 4 weeks

Intervention Type: DRUG

Montelukast

montelukast 4 mg day for 4 weeks

Intervention Type: DRUG

Other Intervention Names

antileukotrienes; antileukotrienes

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Policlinico

OTHER

Sponsor Role: collaborator

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Boner Attilio

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Attilio L Boner, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

Clinica Pediatrica Universita' di Verona Policlinico GB Rossi

Verona, , Italy

Countries

Italy

Other Identifiers

AABB1948

Identifier Type: -

Identifier Source: org_study_id