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The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh | Experimental | Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh |
|
| Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh | Experimental | Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh |
|
| Symbicort Turbuhaler 320/9 ug/inhalation 4 inh | Experimental | Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh |
|
| Symbicort Turbuhaler 320/9 ug/inhalation 1 inh | Experimental | Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh | Drug |
| ||
| Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh |
| Measure | Description | Time Frame |
|---|---|---|
| Average FEV1 | FEV1 determined from serial spirometry and calculated on the basis of area under the curve | 12 h |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum FEV1 | Maximum FEV1 over the 12-hour serial assessments | 12 h |
| FEV1 at 12 h | FEV1 at 12 hours post-dose | 12 h |
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Main inclusion criteria:
Main exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hristo Metev, MD | Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD | Rousse | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27817813 | Derived | Lahelma S, Vahteristo M, Metev H, Taseva M, Stamatova N, Bartha A, Schlezak J, Sairanen U. Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma. Respir Med. 2016 Nov;120:31-35. doi: 10.1016/j.rmed.2016.09.016. Epub 2016 Sep 25. |
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| Drug |
|
| Symbicort Turbuhaler 320/9 ug/inhalation 4 inh | Drug |
|
| Symbicort Turbuhaler 320/9 ug/inhalation 1inh | Drug |
|
| Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh | Drug |
|
| Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh | Drug |
|
| Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh | Drug |
|
| Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh | Drug |
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System 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 | 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 |
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