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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract2007-003169-42 |
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This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium+salmeterol+fluticasone | Experimental |
| |
| Tiotropium+salmeterol+ciclesonide low | Experimental |
| |
| Tiotropium+salmeterol+ciclesonide high | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | Oral inhalation by HandiHaler® device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 response at the end of each 4 week period of randomised treatment | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment | after 4 weeks of each blinded treatment | |
| All adverse events | 24 weeks | |
| Pulse rate and blood pressure (seated) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1249.1.32003 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||||
| 1249.1.32001 Boehringer Ingelheim Investigational Site |
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| Salmeterol | Drug | Oral inhalation from Diskus® |
|
| Fluticasone | Drug | Oral inhalation from metered dose inhaler (MDI) |
|
| Ciclesonide low | Drug | Oral inhalation from MDI |
|
| Ciclesonide high | Drug | Oral inhalation from MDI |
|
| Placebo | Drug | Oral inhalation from MDI |
|
| 24 weeks |
| FEV1 and FVC morning peak response | day 1 and day 28 of each blinded treatment |
| FEV1 and FVC evening peak response | day 1 and day 28 of each blinded treatment |
| FEV1 AUC (0-3h), after 4 weeks of each blinded treatment | after 4 weeks of each blinded treatment |
| FEV1 AUC (12-15h) after 4 weeks of each blinded treatment | after 4 weeks of each blinded treatment |
| FVC AUC (0-3h) after 4 weeks of each blinded treatment | after 4 weeks of each blinded treatment |
| FVC AUC (12-15h) after 4 weeks of each blinded treatment | after 4 weeks of each blinded treatment |
| Trough and peak inspiratory capacity (IC) and vital capacity (VC) response in the morning of day 1 and at day 28 of each treatment period | day 1 and day 28 of each blinded treatment |
| Weekly mean pre-dose morning and evening peak expiratory flow (PEF) | 28 weeks |
| Weekly mean number of occasions of rescue therapy used per day | 28 weeks |
| Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period | 28 weeks |
| Fractional exhaled nitric oxide after 4 weeks of each blinded treatment | after 4 weeks of each blinded treatment |
| Ghent |
| Belgium |
| 1249.1.32002 Boehringer Ingelheim Investigational Site | Hasselt | Belgium |
| 1249.1.32004 Boehringer Ingelheim Investigational Site | Ostend | Belgium |
| 1249.1.45001 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark |
| 1249.1.49001 Boehringer Ingelheim Investigational Site | Großhansdorf | Germany |
| 1249.1.49002 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
| 1249.1.49003 Boehringer Ingelheim Investigational Site | Weinheim | Germany |
| 1249.1.31002 Boehringer Ingelheim Investigational Site | Eindhoven | Netherlands |
| 1249.1.31003 Boehringer Ingelheim Investigational Site | Harderwijk | Netherlands |
| 1249.1.31001 Boehringer Ingelheim Investigational Site | Heerlen | Netherlands |
| 1249.1.31004 Boehringer Ingelheim Investigational Site | Veldhoven | Netherlands |
| 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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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| D000068299 | Salmeterol Xinafoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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