Montelukast in Children With Wheezing

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Azienda Ospedaliera Universitaria Policlinico
Information provided by (Responsible Party):
Boner Attilio, Universita di Verona
ClinicalTrials.gov Identifier:
NCT00775697
First received: October 17, 2008
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Wheezing
Drug: Montelukast
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Lung function test (flow and resistance) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bronchodilator use Dairy symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast
the single arm will receive montelukast
Drug: Montelukast
the arm will be treated with Montelukast 4 mg die for 4 weeks
Other Name: antileukotrienes
Drug: Montelukast
montelukast 4 mg day for 4 weeks
Other Name: antileukotrienes

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

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775697

Locations
Italy
Clinica Pediatrica Universita' di Verona Policlinico GB Rossi
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
Azienda Ospedaliera Universitaria Policlinico
Investigators
Principal Investigator: Attilio L Boner, MD Universita di Verona
  More Information

No publications provided

Responsible Party: Boner Attilio, Prof, Universita di Verona
ClinicalTrials.gov Identifier: NCT00775697     History of Changes
Other Study ID Numbers: AABB1948
Study First Received: October 17, 2008
Last Updated: June 18, 2013
Health Authority: Italy: National Bioethics Committee

Keywords provided by Universita di Verona:
wheezing
children
montelukast
bronchodilators
lung function
Rint

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014