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| Name | Class |
|---|---|
| Azienda Ospedaliera Universitaria Policlinico | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Experimental | the single arm will receive montelukast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | the arm will be treated with Montelukast 4 mg die for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung function test (flow and resistance) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchodilator use Dairy symptoms | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Attilio L Boner, MD | Universita di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Pediatrica Universita' di Verona Policlinico GB Rossi | Verona | 37134 | Italy |
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| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D020024 | Leukotriene Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Montelukast | Drug | montelukast 4 mg day for 4 weeks |
|
|
| D020164 | Chemical Actions and Uses |