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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Bronchial Obstruction, Asthma

Intervention: Formoterol fumerate (Drug); fenoterol/ipratropium bromide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis de Venezuela, Study Chair, Affiliation: Novartis de Venezuela

Summary

To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-<12 years) with acute bronchial obstruction attending emergency services

Clinical Details

Official title: Randomized, Double Blind, Double Dummy, Placebo Controlled Trial to Compare the Effectiveness of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Asthmatic Children (5-<12 Years) With Acute Bronchial Obstruction Attending Emergency Services

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation

Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation

Mean Change in Pulse Oxymetry From Baseline to Final Evaluation

Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation

Secondary outcome:

Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events

Pharmacoeconomic Analysis

Eligibility

Minimum age: 5 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial

obstruction mild to moderate determined by functional and clinical evidence 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

Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigator site - five sites in Caracas, Caracas, Venezuela

Novartis Investigator Site, Maracaibo, Venezuela

Additional Information

Starting date: March 2007
Last updated: March 23, 2011

Page last updated: August 23, 2015

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