A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Meptin swinghaler
* Drug: Berotec


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meptin swinghaler<br> | Drug: Meptin swinghaler<br>* Dose: 10ug/puff, 2 puffs daily Frequency: QD (total 20ug/day) Treatment duration: 2 days<br>|
| Active Comparator: Berotec<br> | Drug: Berotec<br>* Dose: 100ug/puff, 2 puffs daily Frequency: QD (total 200ug/day) Treatment duration: 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Forced Expiratory Volume in 1 second (FEV1) value |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Peak Expiratory Flow Rate (PEFR) |  | 12 months | 
| The change of Forced Vital Capacity (FVC) |  | 12 months | 
| Device acceptance | 5-point score of evaluation form to test preference on Meptin swinghaler/ Berotec device by investigator or patient | 12 months |