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The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma
This study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measures at different timepoints in adult patient with Asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg | Experimental | Inhalation Aerosol, 2 actuations orally inhaled twice daily |
|
| Symbicort® | Active Comparator | Inhalation Aerosol, 2 actuations orally inhaled twice daily |
|
| Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg | Placebo Comparator | Inhalation Aerosol, 2 actuations orally inhaled twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg | Drug | Inhalation aerosol, 2 actuations orally inhaled twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serial Force Expiration volume1 | Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment | From time 0 to 12 hours |
| Change in FEV1 from baseline | FEV1 measured in the morning prior to the dosing of inhaled medication on the last day of the 6 weeks treatment | 6 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Severity of Adverse Events and Serious Adverse Events | Assessment of No. of AEs, its severity, and relatedness and SAE., | 6 weeks treatment |
| Assessment of vital signs: Pulse rate | Assessment of vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orlando Rivero, MD | Global Research Solution | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research | Medford | Oregon | 97504 | United States |
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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 |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol | Drug | Inhalation aerosol, 2 actuations orally inhaled twice daily |
|
|
| Placebo | Drug | Inhalation aerosol, 2 actuations orally inhaled twice daily |
|
|
| 6 weeks treatment |
| Number of participants with suspected oral infection performed with an oropharyngeal examination | Assessment of physical examination including oropharyngeal examination | 6 weeks treatment |
| Assessment of vital signs: Systolic and diastolic Blood Pressures | Assessment of vital signs: Systolic and diastolic Blood Pressures | 6 weeks treatment |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |