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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Meptin swinghaler; Drug: Berotec

• Registration Number: NCT01095016
• Lead Sponsor: Taiwan Otsuka Pharm. Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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;

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meptin swinghaler	Meptin swinghaler	-
Berotec	Berotec	-

Primary Outcome Measures

Name	Time	Method
The change of Forced Expiratory Volume in 1 second (FEV1) value	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chang Cung Memorial Hospital; 🇨🇳 Taipei, Taiwan