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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00990847
Enrollment
140
Registered
2009-10-07
Start date
2007-06-30
Completion date
2008-08-31
Last updated
2009-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Acute Asthma

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.

Interventions

DRUGProcaterol, Salbultamol

Sponsors

PT Otsuka Indonesia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Difference 5% from baseline in asthma score3 times every 20 minutes (at 0, 20 and 40 minutes)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026