A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients
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ClinicalTrials.gov Identifier: NCT01076322 |
Recruitment Status :
Completed
First Posted : February 26, 2010
Last Update Posted : August 12, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Meptin® Swinghaler Drug: Ventolin® MDI | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment-A sequence
Meptin® Swinghaler / Ventolin® MDI
|
Drug: Meptin® Swinghaler
Meptin® Swinghaler®
Other Names:
Drug: Ventolin® MDI Ventolin® MDI
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Experimental: Treatment-B sequence
Ventolin® MDI / Meptin® Swinghaler
|
Drug: Meptin® Swinghaler
Meptin® Swinghaler®
Other Names:
Drug: Ventolin® MDI Ventolin® MDI
|
- The change in Forced Expiratory Volume in 1 second (FEV1) value. [ Time Frame: 2 days ]
- The change in sGaw [ Time Frame: 2 days ]
- The changes in IOS parameters (R, X and RF) [ Time Frame: 2 days ]
- The change in Peak Expiratory Flow Rate (PEFR) [ Time Frame: 2 days ]
- The change in Forced Vital Capacity (FVC) [ Time Frame: 2 days ]
- The change in Oxygen Saturation (SpO2) [ Time Frame: 2 days ]
- The change in Borg scale [ Time Frame: 2 days ]
- Device acceptance [ Time Frame: 2 days ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
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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.
- Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;
Exclusion Criteria:
- Hypersensitivity to β2-agonist or lactose;
- Hospitalization due to asthma during the previous 3months;
- Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- Oral or systemic corticosteroids in the previous 4weeks;
- Inadequately controlled hyperthyroidism;
- Severe hepatic or renal or cardiovascular disease as judged by the investigator;
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076322
Taiwan | |
Taiwan University Hospital | |
Taipei, Taiwan |
Principal Investigator: | Ping-Hung Kuo, MD | National Taiwan University Hospital |
Responsible Party: | Edward C.Y. Peng, Taiwan Otsuka Pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT01076322 |
Other Study ID Numbers: |
002-TWB-0801 |
First Posted: | February 26, 2010 Key Record Dates |
Last Update Posted: | August 12, 2010 |
Last Verified: | February 2010 |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Procaterol Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics |