A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients

NCT ID: NCT01095016

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-10-31

Brief Summary

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

Conditions

Asthma

Study Design

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

Study Groups

Meptin swinghaler

Group Type: EXPERIMENTAL

Meptin swinghaler

Intervention Type: DRUG

• Dose: 10ug/puff, 2 puffs daily
• Frequency: QD (total 20ug/day)
• Treatment duration: 2 days

Berotec

Group Type: ACTIVE_COMPARATOR

Berotec

Intervention Type: DRUG

• Dose: 100ug/puff, 2 puffs daily
• Frequency: QD (total 200ug/day)
• Treatment duration: 2 days

Interventions

Meptin swinghaler

• Dose: 10ug/puff, 2 puffs daily
• Frequency: QD (total 20ug/day)
• Treatment duration: 2 days

Intervention Type: DRUG

Berotec

• Dose: 100ug/puff, 2 puffs daily
• Frequency: QD (total 200ug/day)
• Treatment duration: 2 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or females outpatients aged ≥18 years old with uncontrolled or partly controlled asthma; Stability was assessed during the past 14 days the patients remained in the same severity class by 2006 GINA guideline (uncontrolled, partly controlled) and had no acute exacerbations by investigator judgment;
• Pulmonary function test: Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ; Positive result of Brocho-provocation test;

Exclusion Criteria

• Hypersensitivity to β2-agonist or lactose;
• Hospitalization due to asthma during the previous 3 months;
• Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
• Oral or systemic corticosteroids in the previous 4 weeks;
• Inadequately controlled hyperthyroidism;
• Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system or respiratory disease other than asthma(e.g. COPD), or any other disorder which may interfere wth the study evaluations or affect subject safety;
• Patients receive an investigational drug within 30 days prior to admission to the study;
• Patients with significant alcohol, drug or medication abuse as judged by the investigator;
• 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);
• Subjects who are heavy smoker (more than 10 packs year) or who are smoking within previous 6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiwan Otsuka Pharm. Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Hsiu Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Cung Memorial Hospital

Locations

Chang Cung Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

002-TWB-0901

Identifier Type: -

Identifier Source: org_study_id