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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT01095016
First received: March 15, 2010
Last updated: January 15, 2013
Last verified: January 2013
  Purpose
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

Condition Intervention Phase
Asthma Drug: Meptin swinghaler Drug: Berotec Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Taiwan Otsuka Pharm. Co., Ltd:

Primary Outcome Measures:
  • The change of Forced Expiratory Volume in 1 second (FEV1) value [ Time Frame: 12 months ]

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


Estimated Enrollment: 32
Study Start Date: March 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095016

Locations
Taiwan
Chang Cung Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taiwan Otsuka Pharm. Co., Ltd
Investigators
Principal Investigator: Yu-Hsiu Chung, MD Chang Cung Memorial Hospital
  More Information

Responsible Party: Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier: NCT01095016     History of Changes
Other Study ID Numbers: 002-TWB-0901
Study First Received: March 15, 2010
Last Updated: January 15, 2013

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fenoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 25, 2017