Montelukast in Children With Wheezing

Wheezing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00775697
• Other study ID #: AABB1948
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 17, 2008
• Last updated: June 18, 2013
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: June 2013
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wheezing

Intervention

Drug:
• Montelukast
the arm will be treated with Montelukast 4 mg die for 4 weeks
• Montelukast
montelukast 4 mg day for 4 weeks

Locations

Country	Name	City	State
Italy	Clinica Pediatrica Universita' di Verona Policlinico GB Rossi	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Universita di Verona	Azienda Ospedaliera Universitaria Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function test (flow and resistance)		4 weeks	Yes
Secondary	Bronchodilator use Dairy symptoms		4 weeks	Yes