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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2011-004641-41 |
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This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.
A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 in patients with chronic obstructive pulmonary disease (COPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of AZD2115 25 µg | Experimental |
| |
| Single dose of AZD2115 80 µg | Experimental |
| |
| Single dose of AZD2115 240 µg | Experimental |
| |
| Single doses of placebo | Placebo Comparator |
| |
| Single dose of indacaterol 150 µg | Active Comparator |
| |
| Single dose of indacaterol 150 µg + tiotropium 18 µg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2115 | Drug | AZD2115 administered via inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments | During the first 24 hours following administration | |
| Trough FEV1defined as the average FEV1 from the spirometry assessments | During 22 to 26 hours following administration |
| Measure | Description | Time Frame |
|---|---|---|
| Average FEV1 | FEV1 0-24h post-dose | |
| Peak, average and trough Forced Vital Capacity (FVC) | FVC peak and average 0-24h post-dose and trough 22-26h post-dose | |
| Systemic effect by assessment of blood pressure (BP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carin Jorup, MD | AstraZeneca R&D Molndal, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bialystok | Poland | ||||
| Research Site |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C510790 | indacaterol |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Placebo | Drug | Placebo administered via inhalation |
|
| Indacaterol | Drug | Indacaterol administered via inhalation |
|
| Indacaterol + Tiotropium | Drug | Indacaterol + Tiotropium administered inhalation |
|
| Peak and average 0-4 h post dose |
| Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF) | Peak and average 0-4 h post dose |
| Systemic effect by assessment of Potassium and Glucose | Peak and average 0-4 h post dose |
| Safety and tolerability of 3 different single doses of AZD2115 | At screening, during 0-26 h post-dose and at follow-up |
| Plasma concentrations of AZD2115 after 3 different single doses measured as area under the curve over the time (AUC) and maximum concentration (Cmax), and time to maximum concentration (tmax) | 0-24h post dose |
| Lodz |
| Poland |
| Research Site | Proszowice | Poland |
| Research Site | Łęczna | Poland |
| Research Site | Gothenburg | Sweden |
| Research Site | Lund | Sweden |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |