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

October 6, 2009 updated by: PT Otsuka Indonesia

The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • University of Indonesia/ Persahabatan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference 5% from baseline in peak expiratory flow rate (PEFR)
Time Frame: 3 times every 20 minutes (at 0, 20 and 40 minutes)
3 times every 20 minutes (at 0, 20 and 40 minutes)

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference 5% from baseline in asthma score
Time Frame: 3 times every 20 minutes (at 0, 20 and 40 minutes)
3 times every 20 minutes (at 0, 20 and 40 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Otsuka Indonesia

Investigators

  • Principal Investigator: Hadiarto Mangunnegoro, MD, Department of Pulmonology and Respiratory Medicine, Faculty of Medicine University of Indonesia/ Persahabatan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (Estimate)

October 7, 2009

Study Record Updates

Last Update Posted (Estimate)

October 7, 2009

Last Update Submitted That Met QC Criteria

October 6, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002-IOA-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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