Montelukast in Children With Wheezing
Information source: Universita di Verona
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Wheezing
Intervention: Montelukast (Drug); Montelukast (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Universita di Verona Official(s) and/or principal investigator(s):
Attilio L Boner, MD, Principal Investigator, Affiliation: Universita di Verona
Overall contact:
Attilio L Boner, MD, Phone: -390458124615, Email: attilio.boner@univr.it
Summary
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.
Clinical Details
Official title: Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Lung function test (flow and resistance)
Secondary outcome: Bronchodilator use
Dairy symptoms
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
Minimum age: 6 Months.
Maximum age: 24 Months.
Gender(s): Both.
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
Locations and Contacts
Attilio L Boner, MD, Phone: -390458124615, Email: attilio.boner@univr.it
Clinica Pediatrica Universita' di Verona Policlinico GB Rossi, Verona 37134, Italy
Additional Information
Starting date: September 2009
Ending date: March 2011
Last updated: August 3, 2009
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