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

Moderate Acute Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990847
• Other study ID #: 002-IOA-0601
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2009
• Last updated: October 6, 2009
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: October 2009
• Source: PT Otsuka Indonesia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Asthma
• Moderate Acute Asthma

Intervention

Drug:
• Procaterol, Salbultamol

Locations

Country	Name	City	State
Indonesia	University of Indonesia/ Persahabatan Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT Otsuka Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference 5% from baseline in peak expiratory flow rate (PEFR)		3 times every 20 minutes (at 0, 20 and 40 minutes)	No
Secondary	Difference 5% from baseline in asthma score		3 times every 20 minutes (at 0, 20 and 40 minutes)	No