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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Moderate Acute Asthma

Treatments: Drug: Procaterol, Salbultamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990847

002-IOA-0601

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups

Procaterol

Experimental group

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.

Treatment:

Drug: Procaterol, Salbultamol

Salbultamol

Active Comparator group

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.

Treatment:

Drug: Procaterol, Salbultamol