Montelukast in Children With Wheezing

University of Verona

Status and phase: Unknown; Phase 4

Conditions: Wheezing

Treatments: Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT00775697

AABB1948

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Montelukast

Experimental group

Description:

the single arm will receive montelukast

Treatment:

Drug: Montelukast

Drug: Montelukast