Text Size

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
History of Changes

October 17, 2008
June 18, 2013
September 2009
December 2013   (final data collection date for primary outcome measure)
Lung function test (flow and resistance) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00775697 on ClinicalTrials.gov Archive Site
Bronchodilator use Dairy symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Montelukast in Children With Wheezing
Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years

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.

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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Wheezing
  • 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
Experimental: Montelukast
the single arm will receive montelukast
Interventions:
  • Drug: Montelukast
  • Drug: Montelukast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
6 Months to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00775697
AABB1948
Yes
Boner Attilio, Universita di Verona
Universita di Verona
Azienda Ospedaliera Universitaria Policlinico
Principal Investigator: Attilio L Boner, MD Universita di Verona
Universita di Verona
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP