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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
Montelukast
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
October 17, 2008
Last Updated
June 18, 2013
Sponsor
Universita di Verona
Collaborators
Azienda Ospedaliera Universitaria Policlinico
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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
No
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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