Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstructio

Phase 1

• Conditions: Acute Bronchial Obstruction, Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-004464-11-Outside-EU/EEA
• Lead Sponsor: ovartis de Venezuela S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with severe acute bronchial obstruction determined by functional and clinical evidence
• Patients unable to use the inhaling device at time of treatment
• Patients who received a bronchodilator drug within the last 12 hours
• Patients who received inhaled steroids within the last 72 hours
• Patients who received systemic steroids within the last 7 days
• Patients with near fatal asthma history
• Patients with fever (>38.5°C axillar temp)
• Patients with any clinical significance condition

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified