Montelukast in Children With Wheezing
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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 |
- Lung function test (flow and resistance) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- 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: | March 2011 |
| Estimated Primary Completion Date: | November 2010 (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 |
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| Italy | |
| Clinica Pediatrica Universita' di Verona Policlinico GB Rossi | |
| Verona, Italy, 37134 | |
| Principal Investigator: | Attilio L Boner, MD | Universita di Verona |
More Information
No publications provided
| Responsible Party: | Attilio Boner, Univerita di Verona |
| ClinicalTrials.gov Identifier: | NCT00775697 History of Changes |
| Other Study ID Numbers: | AABB1948 |
| Study First Received: | October 17, 2008 |
| Last Updated: | July 1, 2010 |
| 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 Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013