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Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma

This study has been completed.
Sponsor:
Information provided by:
PT Otsuka Indonesia
ClinicalTrials.gov Identifier:
NCT00990847
First received: October 5, 2009
Last updated: October 6, 2009
Last verified: October 2009
History of Changes
  Purpose

The purpose of this study is to compare the efficacy and safety of nebule procaterol with nebule salbutamol in the treatment of moderate acute asthma.


Condition Intervention Phase
Moderate Acute Asthma
 Drug: Procaterol, Salbultamol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by PT Otsuka Indonesia:

Primary Outcome Measures:
  • Difference 5% from baseline in peak expiratory flow rate (PEFR) [ Time Frame: 3 times every 20 minutes (at 0, 20 and 40 minutes) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference 5% from baseline in asthma score [ Time Frame: 3 times every 20 minutes (at 0, 20 and 40 minutes) ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Procaterol
Procaterol inhalation solution 50 micro g per 0.5 mL diluted in 2mL of NaCl 0.9%, so that the volume of the inhalation solution will be similar to that of the comparator drug. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes.
 Drug: Procaterol, Salbultamol
Active Comparator: Salbultamol
Salbultamol inhalation solution for nebulization containing 2.5 mg in 2.5 mL aqueous solution. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes.
 Drug: Procaterol, Salbultamol

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with moderate acute asthma according to Global Initiative for Asthma (GINA) 1998 (Appendix 1). Patients with moderate acute asthma according to Modified Global Initiative for Asthma (GINA) 1998 (Patients with asthma score 5 - 11; PEFR ≤ 80% predicted)
  2. Patients of both gender aged 15 to 60 years
  3. Patients still have the ability to undergo examinations and give written informed consent

Exclusion Criteria:

  1. Pregnant and lactating women
  2. Smokers
  3. Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases
  4. Patients with signs of severe infections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990847

Locations
Indonesia
University of Indonesia/ Persahabatan Hospital
Jakarta, Indonesia
Sponsors and Collaborators
PT Otsuka Indonesia
Investigators
Principal Investigator: Hadiarto Mangunnegoro, MD Department of Pulmonology and Respiratory Medicine, Faculty of Medicine University of Indonesia/ Persahabatan Hospital
  More Information

No publications provided

Responsible Party: Albertus Widjaja/Medical Director, PT Otsuka Indonesia
ClinicalTrials.gov Identifier: NCT00990847     History of Changes
Other Study ID Numbers: 002-IOA-0601
Study First Received: October 5, 2009
Last Updated: October 6, 2009
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Procaterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics

ClinicalTrials.gov processed this record on June 17, 2013