|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Universita di Verona |
|---|---|
| Collaborator: |
Azienda Ospedaliera Universitaria Policlinico |
| Information provided by: | Universita di Verona |
| ClinicalTrials.gov Identifier: | NCT00775697 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Montelukast: Experimental
the single arm will receive montelukast
|
Drug: Montelukast
the arm will be treated with Montelukast 4 mg die for 4 weeks
Drug: Montelukast
montelukast 4 mg day for 4 weeks
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Attilio L Boner, MD | -390458124615 | attilio.boner@univr.it |
| Italy | |
| Clinica Pediatrica Universita' di Verona Policlinico GB Rossi | |
| Verona, Italy, 37134 | |
| Principal Investigator: | Attilio L Boner, MD | Universita di Verona |
More Information
| Responsible Party: | Univerita di Verona ( Attilio Boner ) |
| Study ID Numbers: | AABB1948 |
| Study First Received: | October 17, 2008 |
| Last Updated: | August 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00775697 History of Changes |
| Health Authority: | Italy: National Bioethics Committee |
|
wheezing children montelukast |
bronchodilators lung function Rint |
|
Montelukast Respiratory System Agents Signs and Symptoms Respiratory Sounds Therapeutic Uses Hormone Antagonists |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Signs and Symptoms, Respiratory Pharmacologic Actions Leukotriene Antagonists |
