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Completed

NCT Number: NCT00460577

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

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

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Key information

Conditions

Acute Bronchial Obstruction, Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formoterol fumerate

Drug

12 micrograms stat (twice if necessary). Inhaled via aerolizer

fenoterol/ipratropium bromide

Drug

0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.

Primary outcomes

  1. Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation

    Time frame: Baseline,4 hours

    Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.

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

    Time frame: Baseline,4 hours

    Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.

  3. Mean Change in Pulse Oxymetry From Baseline to Final Evaluation

    Time frame: Baseline, 4 hours

    Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.

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

    Time frame: Baseline,4 hours

    Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.

Secondary outcomes

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

    Time frame: 4 hours

    Not posted: see comment in Limitations and Caveats.

  2. Pharmacoeconomic Analysis

    Time frame: 4 hours

    Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 16, 2007
Registry last updated
Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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