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

Primary Purpose

Moderate Acute Asthma

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Procaterol, Salbultamol
Sponsored by
PT Otsuka Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Acute Asthma

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Indonesia/ Persahabatan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Procaterol

Salbultamol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference 5% from baseline in peak expiratory flow rate (PEFR)

Secondary Outcome Measures

Difference 5% from baseline in asthma score

Full Information

First Posted
October 5, 2009
Last Updated
October 6, 2009
Sponsor
PT Otsuka Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT00990847
Brief Title
Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma
Official Title
The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PT Otsuka Indonesia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Acute Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procaterol
Arm Type
Experimental
Arm Description
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.
Arm Title
Salbultamol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Procaterol, Salbultamol
Primary Outcome Measure Information:
Title
Difference 5% from baseline in peak expiratory flow rate (PEFR)
Time Frame
3 times every 20 minutes (at 0, 20 and 40 minutes)
Secondary Outcome Measure Information:
Title
Difference 5% from baseline in asthma score
Time Frame
3 times every 20 minutes (at 0, 20 and 40 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Patients of both gender aged 15 to 60 years Patients still have the ability to undergo examinations and give written informed consent Exclusion Criteria: Pregnant and lactating women Smokers Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases Patients with signs of severe infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadiarto Mangunnegoro, MD
Organizational Affiliation
Department of Pulmonology and Respiratory Medicine, Faculty of Medicine University of Indonesia/ Persahabatan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Indonesia/ Persahabatan Hospital
City
Jakarta
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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