NCT00775697

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4.3 years

First QC Date

October 17, 2008

Last Update Submit

June 18, 2013

Conditions

Wheezing

Keywords

wheezingchildrenmontelukastbronchodilatorslung functionRint

Outcome Measures

Primary Outcomes (1)

  • Lung function test (flow and resistance)

    4 weeks

Secondary Outcomes (1)

  • Bronchodilator use Dairy symptoms

    4 weeks

Study Arms (1)

Montelukast

EXPERIMENTAL

the single arm will receive montelukast

Drug: Montelukast

Interventions

MontelukastDRUG

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

Also known as: antileukotrienes
Montelukast

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 6-24 months
  • Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
  • Patients with symptoms at enrollment

You may not qualify if:

  • Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Pediatrica Universita' di Verona Policlinico GB Rossi

Verona, 37134, Italy

Location

MeSH Terms

Conditions

Respiratory Sounds

Interventions

montelukastLeukotriene Antagonists

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Attilio L Boner, MD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

IT(1)