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

NCT ID: NCT01076322

Last Updated: 2010-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-06-30

Brief 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment-A sequence

Meptin® Swinghaler / Ventolin® MDI

Group Type: EXPERIMENTAL

Meptin® Swinghaler

Intervention Type: DRUG

Meptin® Swinghaler®

• Ingredient: Procaterol HCL
• Dosage form: 10g/puff
• Dose(s): 10g
• Dosing schedule: 20g (total 20g)

Ventolin® MDI

Intervention Type: DRUG

Ventolin® MDI

• Ingredient: Salbutamol sulfate
• Dosage form: 100g/puff
• Dose(s): 100g
• Dosing schedule: 200g (total 200g)

Treatment-B sequence

Ventolin® MDI / Meptin® Swinghaler

Group Type: EXPERIMENTAL

Meptin® Swinghaler

Intervention Type: DRUG

Meptin® Swinghaler®

• Ingredient: Procaterol HCL
• Dosage form: 10g/puff
• Dose(s): 10g
• Dosing schedule: 20g (total 20g)

Ventolin® MDI

Intervention Type: DRUG

Ventolin® MDI

• Ingredient: Salbutamol sulfate
• Dosage form: 100g/puff
• Dose(s): 100g
• Dosing schedule: 200g (total 200g)

Interventions

Meptin® Swinghaler

Meptin® Swinghaler®

• Ingredient: Procaterol HCL
• Dosage form: 10g/puff
• Dose(s): 10g
• Dosing schedule: 20g (total 20g)

Intervention Type: DRUG

Ventolin® MDI

Ventolin® MDI

• Ingredient: Salbutamol sulfate
• Dosage form: 100g/puff
• Dose(s): 100g
• Dosing schedule: 200g (total 200g)

Intervention Type: DRUG

Other Intervention Names

Meptin® Swinghaler®; Procaterol HCL; Ventolin® MDI; Salbutamol sulfate

Eligibility 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).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiwan Otsuka Pharm. Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Taiwan Otsuka Pharmaceutical Co., Ltd

Principal Investigators

Ping-Hung Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

002-TWB-0801

Identifier Type: -

Identifier Source: org_study_id