Montelukast in Children With Wheezing
|ClinicalTrials.gov Identifier: NCT00775697|
Recruitment Status : Unknown
Verified June 2013 by Boner Attilio, Universita di Verona.
Recruitment status was: Enrolling by invitation
First Posted : October 20, 2008
Last Update Posted : June 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Wheezing||Drug: Montelukast||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
the single arm will receive montelukast
the arm will be treated with Montelukast 4 mg die for 4 weeks
Other Name: antileukotrienesDrug: Montelukast
montelukast 4 mg day for 4 weeks
Other Name: antileukotrienes
- Lung function test (flow and resistance) [ Time Frame: 4 weeks ]
- Bronchodilator use Dairy symptoms [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775697
|Clinica Pediatrica Universita' di Verona Policlinico GB Rossi|
|Verona, Italy, 37134|
|Principal Investigator:||Attilio L Boner, MD||Universita di Verona|