A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in 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 Ventolin® MDI in stable asthma patients.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Meptin® Swinghaler
* Drug: Ventolin® MDI


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 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: Treatment-A sequence<br>Meptin® Swinghaler / Ventolin® MDI | Drug: Meptin® Swinghaler<br>* Meptin® Swinghaler® Ingredient: Procaterol HCL Dosage form: 10g/puff Dose(s): 10g Dosing schedule: 20g (total 20g)<br>* Other names: Salbutamol sulfate;Drug: Ventolin® MDI<br>* Ventolin® MDI Ingredient: Salbutamol sulfate Dosage form: 100g/puff Dose(s): 100g Dosing schedule: 200g (total 200g)<br>|
| Experimental: Treatment-B sequence<br>Ventolin® MDI / Meptin® Swinghaler | Drug: Meptin® Swinghaler<br>* Meptin® Swinghaler® Ingredient: Procaterol HCL Dosage form: 10g/puff Dose(s): 10g Dosing schedule: 20g (total 20g)<br>* Other names: Salbutamol sulfate;Drug: Ventolin® MDI<br>* Ventolin® MDI Ingredient: Salbutamol sulfate Dosage form: 100g/puff Dose(s): 100g Dosing schedule: 200g (total 200g)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Forced Expiratory Volume in 1 second (FEV1) value. |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in sGaw |  | 2 days | 
| The changes in IOS parameters (R, X and RF) |  | 2 days | 
| The change in Peak Expiratory Flow Rate (PEFR) |  | 2 days | 
| The change in Forced Vital Capacity (FVC) |  | 2 days | 
| The change in Oxygen Saturation (SpO2) |  | 2 days | 
| The change in Borg scale |  | 2 days | 
| Device acceptance |  | 2 days |