A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Ventolin® MDI in stable asthma patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Otsuka Pharm. Co., Ltd
• Treatments: Albuterol; Procaterol

Criteria

Inclusion Criteria:

1. Male or females outpatients aged ≥ 16 years old with stable mild to moderate persistent asthma; Stability was assessed the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days;

2. Pulmonary function test:

• Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ;

• Positive result of Broncho-provocation test (PC20 ≤ 32 mg/ml) before the study.

3. Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;

Exclusion Criteria:

1. Hypersensitivity to β2-agonist or lactose;

2. Hospitalization due to asthma during the previous 3months;

3. Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;

4. Oral or systemic corticosteroids in the previous 4weeks;

5. Inadequately controlled hyperthyroidism;

6. Severe hepatic or renal or cardiovascular disease as judged by the investigator;

7. Patients receive an investigational drug within 30 days prior to admission to the study;

8. Patients with significant alcohol, drug or medication abuse as judged by the investigator;

9. Females who are pregnant or breast-feeding; (exception: Females of child-bearing age might be included, if in the opinion of the investigator, they are using adequate contraceptive precautions).