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The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.
This study will assess and compare the safety and tolerability of inhaled TPI 1020 versus budesonide. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will also be studied in a sub-group of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaler | Experimental | TPI 1020 |
|
| Inhaler cortico. | Active Comparator | Budesonide inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPI-1020 | Drug | 600 mcg BID x 14 days followed by 1200 mcg BID x 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22 | 22 days | |
| To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14 | 22 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Renzi, MD | Syntara | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University Hospital | Hamilton | Ontario | L8N 3Z5 | Canada | ||
| Kingston General 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 |
|---|---|
| C492926 | NCX 1020 |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| budesonide |
| Drug |
400 mcg BID x 14 days then 800 mcg/day x 7 more days |
|
| To compare pre-dose FEV1 measurements on multiple days throughout the study | 22 days |
| To compare peak flow measurements throughout the study | 22 days |
| To compare the use of daily rescue medication (salbutamol) throughout the study | 22 days |
| To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period | 22 days |
| Kingston |
| Ontario |
| K7L 106 |
| Canada |
| CARL | Laval | Quebec | H7V 3Y7 | Canada |
| Montreal Chest Institute | Montreal | Quebec | H2X 2P4 | Canada |
| Hopital Sacre Coeur | Montreal | Quebec | H4J 1G5 | Canada |
| Centre Hospitalier St-Sacrement | Ste-Foy | Quebec | G1S 4L8 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval | Ste-Foy | Quebec | G1V 4G5 | Canada |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |