A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients
This study has been completed.
Sponsor:
Taiwan Otsuka Pharm. Co., Ltd
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
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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:
MedlinePlus related topics:
Asthma
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
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®
Other Names:
Drug: Ventolin® MDI
Ventolin® MDI
|
|
Experimental: Treatment-B sequence
Ventolin® MDI / Meptin® Swinghaler
|
Drug: Meptin® Swinghaler
Meptin® Swinghaler®
Other Names:
Drug: Ventolin® MDI
Ventolin® MDI
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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;
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).
Contacts and Locations
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 Procaterol Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Sympathomimetics |
ClinicalTrials.gov processed this record on June 17, 2013