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

Phase 3

Completed

• Conditions: Moderate Acute Asthma
• Interventions: Drug: Procaterol, Salbultamol

• Registration Number: NCT00990847
• Lead Sponsor: PT Otsuka Indonesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-04
• Study Completion: 2008-08
• Status Verified: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-06
• Last Update Submitted: 2009-10-06
• Study First Posted: 2009-10-07
• Last Update Posted: 2009-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salbultamol	Procaterol, 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.
Procaterol	Procaterol, Salbultamol	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference 5% from baseline in asthma score	3 times every 20 minutes (at 0, 20 and 40 minutes)

Trial Locations

Locations (1)

University of Indonesia/ Persahabatan Hospital; 🇮🇩 Jakarta, Indonesia