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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2009-015645-23 |
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Study stopped since it was considered that one of the pre-defined stopping criterion was met.
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The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled AZD9164 following administration of multiple ascending doses in healthy male and female subjects and COPD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | AZD9164 |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9164 Turbuhaler® | Drug | Dry powder for inhalation via Turbuhaler, MAD. Starting dose in healthy volunteers is 400 µg with up to two dose escalations not exceeding AstraZeneca pre-defined exposure limits. The COPD patients will receive a dose of 1000 µg. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events) | Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics samples for AZD9164 | PK sampling during the residential period and intense PK sampling day 1 and 15 in healthy and day 13 in COPD patients | |
| Investigation of PD effects | Spirometry at screening and during the residential stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carin Jorup | AstraZeneca R&D, Lund, Sweden | Study Director |
| Aslak Rautio | Quintiles Hermelinen AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Linköping | Sweden | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24669829 | Derived | Jorup C, Bengtsson T, Strandgarden K, Sjobring U. Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. BMC Pulm Med. 2014 Mar 27;14:52. doi: 10.1186/1471-2466-14-52. |
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| Placebo Turbuhaler® | Drug | Dry powder for inhalation via Turbuhaler, MAD |
|
| Luleå |
| Sweden |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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