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| ID | Type | Description | Link |
|---|---|---|---|
| INTB012 | Other Identifier | Taiwan FDA |
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The objective of the study is to evaluate the dose response of SYN006 HFA MDI, which is a combination drug product of budesonide and procaterol hydrochloride, in asthma patients. Patients with mild to moderate asthma will be recruited. There will be two study medication administered in this study. The investigational medication is SYN006 (Budesonide/Procaterol hydrochloride, 180 mcg/10 mcg per inhalation) and the active comparative medication is Ventolin (Salbutamol sulfate 100 mcg per inhalation). The study medication will be administered by oral inhalation with the supervision of the investigator or a qualified staff.
Three treatments will be administered in a patient:
Patients will be received the study treatment according to one of the six treatment sequences according to the randomization schedule:
The efficacy endpoint is
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide/procaterol 180/10mcg X1 | Experimental | HFA MDI, oral inhalation, 180/10mcg, one puff |
|
| Budesonide/Procaterol, 180/10mcg X2 | Experimental | HFA MDI, oral inhalation, two puffs |
|
| Albuterol HFA MDI 100 mcg X2 | Active Comparator | HFA MDI, oral inhalation, 100mcg, two puffs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Procaterol, 180/10mcg X1 | Drug | one puff |
|
| Measure | Description | Time Frame |
|---|---|---|
| The variation of study medications by the area under curve of FEV1 from 0 to 120 minutes (AUC0-120min ) after inhalation. | 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| The change in Forced Expiratory Volume in 1 second (FEV1) of study medication. | 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation | |
| The change in Peak Expiratory Flow Rate (PEFR) of study medication. | 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, vital signs, abnormal ECG outcome. | 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation |
Inclusion Criteria:
Mild Persistent:
Moderate Persistent:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | Taiwan | ||||
| National Taiwan University Hospital |
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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 |
|---|---|
| D019819 | Budesonide |
| D017265 | Procaterol |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide/procaterol 180/10 mcg X 2 | Drug | 2 puffs |
|
|
| Albuterol HFA MDI 100mcg X2 | Drug | HFA MDI, 100mcg, 2 puffs |
|
|
| The change in Forced Vital Capacity (FVC) of study medication. | 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation |
| The variation of study medications by the area under curve of PEFR from 0 to 120 minutes (AUC0-120min ) after inhalation. | 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation |
| The variation of study medications by the area under curve of FVC from 0 to 120 minutes (AUC0-120min ) after inhalation. | 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation |
| Taipei |
| Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |