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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-A sequence | Experimental | Meptin® Swinghaler / Ventolin® MDI |
|
| Treatment-B sequence | Experimental | Ventolin® MDI / Meptin® Swinghaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meptin® Swinghaler | Drug | Meptin® Swinghaler®
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in Forced Expiratory Volume in 1 second (FEV1) value. | 2 days |
| 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) |
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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:
Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping-Hung Kuo, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taiwan University Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Ventolin® MDI | Drug | Ventolin® MDI
|
|
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |