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Montelukast in Children With Wheezing

Primary Purpose

Wheezing

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Montelukast

About this trial

This is an interventional treatment trial for Wheezing focused on measuring wheezing, children, montelukast, bronchodilators, lung function, Rint

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept 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

Sites / Locations

Clinica Pediatrica Universita' di Verona Policlinico GB Rossi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Montelukast

Arm Description

the single arm will receive montelukast

Outcomes

Primary Outcome Measures

Lung function test (flow and resistance)

Secondary Outcome Measures

Bronchodilator use Dairy symptoms

Full Information

NCT ID

NCT00775697

First Posted

October 17, 2008

Last Updated

June 18, 2013

Sponsor

Universita di Verona

Collaborators

Azienda Ospedaliera Universitaria Policlinico

1. Study Identification

Unique Protocol Identification Number

NCT00775697

Brief Title

Montelukast in Children With Wheezing

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universita di Verona

Collaborators

Azienda Ospedaliera Universitaria Policlinico

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wheezing

Keywords

wheezing, children, montelukast, bronchodilators, lung function, Rint

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Montelukast

Arm Type

Experimental

Arm Description

the single arm will receive montelukast

Intervention Type

Drug

Intervention Name(s)

Montelukast

Other Intervention Name(s)

antileukotrienes

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Montelukast

Other Intervention Name(s)

antileukotrienes

Intervention Description

montelukast 4 mg day for 4 weeks

Primary Outcome Measure Information:

Title

Lung function test (flow and resistance)

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Bronchodilator use Dairy symptoms

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Attilio L Boner, MD

Organizational Affiliation

Universita di Verona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinica Pediatrica Universita' di Verona Policlinico GB Rossi

City

Verona

ZIP/Postal Code

37134

Country

Italy

12. IPD Sharing Statement

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Montelukast in Children With Wheezing

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