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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Asthma	Drug: Meptin® Swinghaler; Drug: Ventolin® MDI	Phase 3

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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)

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The change in Forced Expiratory Volume in 1 second (FEV1) value. [ Time Frame: 2 days ]

Secondary Outcome Measures :

1. The change in sGaw [ Time Frame: 2 days ]
2. The changes in IOS parameters (R, X and RF) [ Time Frame: 2 days ]
3. The change in Peak Expiratory Flow Rate (PEFR) [ Time Frame: 2 days ]
4. The change in Forced Vital Capacity (FVC) [ Time Frame: 2 days ]
5. The change in Oxygen Saturation (SpO2) [ Time Frame: 2 days ]
6. The change in Borg scale [ Time Frame: 2 days ]
7. Device acceptance [ Time Frame: 2 days ]

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	February 26, 2010
Last Update Posted:	August 12, 2010
Last Verified:	February 2010

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; 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