A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients

This study has been completed.
Sponsor:
Information provided by:
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT01076322
First received: February 24, 2010
Last updated: August 10, 2010
Last verified: February 2010
  Purpose

This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Ventolin® MDI in stable asthma patients.


Condition Intervention Phase
Asthma
Drug: Meptin® Swinghaler
Drug: Ventolin® MDI
Phase 3

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The change in Forced Expiratory Volume in 1 second (FEV1) value. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in sGaw [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • The changes in IOS parameters (R, X and RF) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • The change in Peak Expiratory Flow Rate (PEFR) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • The change in Forced Vital Capacity (FVC) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • The change in Oxygen Saturation (SpO2) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • The change in Borg scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Device acceptance [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 17
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment-A sequence
Meptin® Swinghaler / Ventolin® MDI
Drug: Meptin® Swinghaler

Meptin® Swinghaler®

  • Ingredient: Procaterol HCL
  • Dosage form: 10g/puff
  • Dose(s): 10g
  • Dosing schedule: 20g (total 20g)
Other Names:
  • Meptin® Swinghaler®
  • Procaterol HCL
  • Ventolin® MDI
  • Salbutamol sulfate
Drug: Ventolin® MDI

Ventolin® MDI

  • Ingredient: Salbutamol sulfate
  • Dosage form: 100g/puff
  • Dose(s): 100g
  • Dosing schedule: 200g (total 200g)
Experimental: Treatment-B sequence
Ventolin® MDI / Meptin® Swinghaler
Drug: Meptin® Swinghaler

Meptin® Swinghaler®

  • Ingredient: Procaterol HCL
  • Dosage form: 10g/puff
  • Dose(s): 10g
  • Dosing schedule: 20g (total 20g)
Other Names:
  • Meptin® Swinghaler®
  • Procaterol HCL
  • Ventolin® MDI
  • Salbutamol sulfate
Drug: Ventolin® MDI

Ventolin® MDI

  • Ingredient: Salbutamol sulfate
  • Dosage form: 100g/puff
  • Dose(s): 100g
  • Dosing schedule: 200g (total 200g)

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or females outpatients aged ≥ 16 years old with stable mild to moderate persistent asthma; Stability was assessed the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days;
  2. Pulmonary function test:

    • Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ;
    • Positive result of Broncho-provocation test (PC20 ≤ 32 mg/ml) before the study.
  3. Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;

Exclusion Criteria:

  1. Hypersensitivity to β2-agonist or lactose;
  2. Hospitalization due to asthma during the previous 3months;
  3. Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
  4. Oral or systemic corticosteroids in the previous 4weeks;
  5. Inadequately controlled hyperthyroidism;
  6. Severe hepatic or renal or cardiovascular disease as judged by the investigator;
  7. Patients receive an investigational drug within 30 days prior to admission to the study;
  8. Patients with significant alcohol, drug or medication abuse as judged by the investigator;
  9. 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).
  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: NCT01076322

Locations
Taiwan
Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taiwan Otsuka Pharm. Co., Ltd
Investigators
Principal Investigator: Ping-Hung Kuo, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Edward C.Y. Peng, Taiwan Otsuka Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01076322     History of Changes
Other Study ID Numbers: 002-TWB-0801
Study First Received: February 24, 2010
Last Updated: August 10, 2010
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
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 September 18, 2014