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

An Open-label, Randomized, Cross-over, Active-controlled Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Meptin swinghaler; Drug: Berotec

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Chang Cung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meptin swinghaler	Drug: Meptin swinghaler; Dose: 10ug/puff, 2 puffs daily; Frequency: QD (total 20ug/day); Treatment duration: 2 days
Active Comparator: Berotec	Drug: Berotec; Dose: 100ug/puff, 2 puffs daily; Frequency: QD (total 200ug/day); Treatment duration: 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of Forced Expiratory Volume in 1 second (FEV1) value	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Peak Expiratory Flow Rate (PEFR)		12 months
The change of Forced Vital Capacity (FVC)		12 months
Device acceptance	5-point score of evaluation form to test preference on Meptin swinghaler/ Berotec device by investigator or patient	12 months

Collaborators and Investigators

• Sponsor: Taiwan Otsuka Pharm. Co., Ltd
• Investigators: Principal Investigator: Yu-Hsiu Chung, MD, Chang Cung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 26, 2010
• First Posted (Estimate): March 29, 2010

Study Record Updates

• Last Update Posted (Estimate): January 16, 2013
• Last Update Submitted That Met QC Criteria: January 15, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Fenoterol
• Other Study ID Numbers: 002-TWB-0901