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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095016
• Other study ID #: 002-TWB-0901
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2010
• Last updated: January 15, 2013
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: Taiwan Otsuka Pharm. Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß2-agonist before the study or ; Positive result of Brocho-provocation test;

Exclusion Criteria:

• Hypersensitivity to ß2-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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Meptin swinghaler
Dose: 10ug/puff, 2 puffs daily Frequency: QD (total 20ug/day) Treatment duration: 2 days
• Berotec
Dose: 100ug/puff, 2 puffs daily Frequency: QD (total 200ug/day) Treatment duration: 2 days

Locations

Country	Name	City	State
Taiwan	Chang Cung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Otsuka Pharm. Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of Forced Expiratory Volume in 1 second (FEV1) value		12 months	No
Secondary	The change of Peak Expiratory Flow Rate (PEFR)		12 months	No
Secondary	The change of Forced Vital Capacity (FVC)		12 months	No
Secondary	Device acceptance	5-point score of evaluation form to test preference on Meptin swinghaler/ Berotec device by investigator or patient	12 months	No