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OpenTrials
Completed

NCT Number: NCT01095016

A 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chang Cung Memorial Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meptin swinghaler

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

Berotec

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

Primary outcomes

  1. The change of Forced Expiratory Volume in 1 second (FEV1) value

    Time frame: 12 months

Secondary outcomes

  1. The change of Peak Expiratory Flow Rate (PEFR)

    Time frame: 12 months

  2. The change of Forced Vital Capacity (FVC)

    Time frame: 12 months

  3. Device acceptance

    Time frame: 12 months

    5-point score of evaluation form to test preference on Meptin swinghaler/ Berotec device by investigator or patient

Sponsors and collaborators

Lead sponsor

Taiwan Otsuka Pharm. Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2010
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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