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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-15-07-013749 | Other Identifier | EUDAMED No |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.
The aim of the study is to measure inspiratory profiles of patients with non-Cystic fibrosis bronchiectasis using the breath activated T-326 Inhaler.
The following parameters will be derived from the inspiratory profiles:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-326 | Experimental | Non Cystic fibrosis bronchiectasis patients will be enrolled for determination of peak inspiratory flow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-326 Inhaler | Device | No drug dosing,three test inhalations through the inhaler device filled with an empty capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak inspiratory flow (L/min) | Visit 2 (1-14 days after screening visit 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory volumes (V in L) | Visit 2 (1-14 days after screening visit 1) | |
| Inspiratory time (t in s) | Visit 2 (1-14 days after screening visit 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gauting | Bavaria | 82131 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30848695 | Derived | Stass H, Nagelschmitz J, Kappeler D, Sommerer K, Patzlaff A, Weimann B. Ciprofloxacin Dry Powder for Inhalation: Inspiratory Flow in Patients with Non-cystic Fibrosis Bronchiectasis. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):156-163. doi: 10.1089/jamp.2018.1464. Epub 2019 Mar 8. |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| Landsberg am Lech |
| Bavaria |
| 86899 |
| Germany |
| München | Bavaria | 80336 | Germany |
| München | Bavaria | 80539 | Germany |
| München | Bavaria | 81241 | Germany |
| Frankfurt am Main | Hesse | 60389 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Neu-Isenburg | Hesse | 63263 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Großhansdorf | 22927 | Germany |