Skip to main content
Clinical Trials/NCT00775697
NCT00775697UnknownPhase 4

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

Universita di Verona1 site in 1 country40 target enrollmentStarted: September 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Lung function test (flow and resistance)

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Months to 24 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Montelukast

Experimental

the single arm will receive montelukast

Intervention: Montelukast (Drug)

Outcomes

Primary Outcomes

Lung function test (flow and resistance)

Time Frame: 4 weeks

Secondary Outcomes

  • Bronchodilator use Dairy symptoms(4 weeks)

Investigators

Sponsor
Universita di Verona
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Boner Attilio

Prof

Universita di Verona

Study Sites (1)

Loading locations...

Similar Trials