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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014