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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005107-17 | EudraCT Number | EudraCT |
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The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium/Salmeterol QD | Experimental | Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule |
|
| Tiotropium QD | Active Comparator | Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®) |
|
| Salmeterol BID | Active Comparator | Salmeterol Inhalation Powder, hard PE capsule |
|
| Tiotropium/Salmeterol QD + Salmeterol | Active Comparator | Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule |
|
| Placebo | Placebo Comparator | Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium/Salmeterol | Drug | Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 response | 12 Weeks, 24 Weeks and 48 Weeks | |
| FEV1AUC 0 8hr response | 12 Weeks, 24 Weeks and 48 Weeks | |
| Mahler TDI focal score | 12 Weeks, 24 Weeks and 48 Weeks | |
| SGRQ total score | 12 Weeks, 24 Weeks and 48 Weeks | |
| Time to first moderate to severe COPD exacerbation | 12 Weeks, 24 Weeks and 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 response | 4, 36 and 48 weeks | |
| FEV1 AUC0-8h response | 4, 36 and 48 weeks | |
| Peak FEV1 response |
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Inclusion criteria:
Main:
Diagnosis of COPD Post-bronchodilator FEV1<80% predicted and FEV1/FVC<70% predicted
Exclusion criteria:
Main:
Significant other diseases then COPD Recent MI Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year Hospitalisation for cardiac failure during the past year History of asthma
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1184.15.01069 Boehringer Ingelheim Investigational Site | Anniston | Alabama | United States | |||
| 1184.15.01071 Boehringer Ingelheim Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 15, 2024 | |
| Reset | Nov 4, 2024 | |
| Release | Nov 29, 2024 |
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| Tiotropium/Salmeterol QD + Salmeterol | Drug | Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule |
|
| Placebo | Drug | Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule |
|
| Salmeterol | Drug | Salmeterol Inhalation Powder, hard PE capsule |
|
| Tiotropium | Drug | Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®) |
|
| 12, 24, 36 and 48 weeks |
| Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time) | 24 hours |
| Weekly mean number of COPD related night time awakenings | 1 week |
| FVC (forced vital capacity) AUC0-8h and trough FVC response | 48 weeks |
| Individual FEV1, FVC and PEF measurements | 48 weeks |
| Weekly mean morning pre-dose and evening pre-dose PEFs (peak expiratory flow) and FEV1 (recorded by AM2+); PEFs determined by spirometry ] | 48 weeks |
| Mahler TDI focal score | 4, 36 and 48 weeks |
| Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort) | 4, 12, 24, 36 and 48 weeks |
| SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ | 4, 12, 36 and 48 weeks |
| All adverse events | 48 weeks |
| Vital signs: pulse rate and blood pressure | Baseline and 4 weeks |
| Routine blood chemistry, haematology and urinalysis | Baseline and 48 weeks |
| Vital status of randomised patients | 48 weeks |
| Number of days in hospital (including ambulance transportation | 48 weeks |
| Number of unscheduled health care provider visits | 48 weeks |
| Number of visits in emergency room (including ambulance transportation) | 48 weeks |
| Number of days in intensive care unit | 48 weeks |
| Concomitant medications (for instance antibiotics and systemic steroids) | 48 weeks |
| Mobile |
| Alabama |
| United States |
| 1184.15.01054 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States |
| 1184.15.01063 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| 1184.15.01064 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| 1184.15.01065 Boehringer Ingelheim Investigational Site | Savannah | Georgia | United States |
| 1184.15.01052 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States |
| 1184.15.01055 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1184.15.01058 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1184.15.01062 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1184.15.01072 Boehringer Ingelheim Investigational Site | Summit | New Jersey | United States |
| 1184.15.01053 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States |
| 1184.15.01070 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 1184.15.01057 Boehringer Ingelheim Investigational Site | Elizabeth City | North Carolina | United States |
| 1184.15.01059 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 1184.15.01051 Boehringer Ingelheim Investigational Site | Morgantown | West Virginia | United States |
| 1184.15.43052 Boehringer Ingelheim Investigational Site | Gänserndorf | Austria |
| 1184.15.43053 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1184.15.02057 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1184.15.02059 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1184.15.02055 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1184.15.02058 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada |
| 1184.15.02051 Boehringer Ingelheim Investigational Site | Scarborough Village | Ontario | Canada |
| 1184.15.02053 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1184.15.02060 Boehringer Ingelheim Investigational Site | Longueuil | Quebec | Canada |
| 1184.15.02056 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1184.15.45054 Boehringer Ingelheim Investigational Site | Aalborg | Denmark |
| 1184.15.45052 Boehringer Ingelheim Investigational Site | Kolding | Denmark |
| 1184.15.45051 Boehringer Ingelheim Investigational Site | Odense C | Denmark |
| 1184.15.45053 Boehringer Ingelheim Investigational Site | Silkeborg | Denmark |
| 1184.15.37252 Boehringer Ingelheim Investigational Site | Kohtla-Järve | Estonia |
| 1184.15.37251 Boehringer Ingelheim Investigational Site | Tallinn | Estonia |
| 1184.15.35852 Boehringer Ingelheim Investigational Site | Oulu | Finland |
| 1184.15.35851 Boehringer Ingelheim Investigational Site | Tampere | Finland |
| 1184.15.3350A Boehringer Ingelheim Investigational Site | Marseille | France |
| 1184.15.3351A Boehringer Ingelheim Investigational Site | Nantes | France |
| 1184.15.3352A Boehringer Ingelheim Investigational Site | Paris | France |
| 1184.15.49056 Boehringer Ingelheim Investigational Site | Aschaffenburg | Germany |
| 1184.15.49053 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 1184.15.49057 Boehringer Ingelheim Investigational Site | Gelnhausen | Germany |
| 1184.15.49052 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1184.15.49058 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1184.15.36055 Boehringer Ingelheim Investigational Site | Deszk | Hungary |
| 1184.15.36053 Boehringer Ingelheim Investigational Site | Érd | Hungary |
| 1184.15.36054 Boehringer Ingelheim Investigational Site | Szarvas | Hungary |
| 1184.15.36052 Boehringer Ingelheim Investigational Site | Szeged | Hungary |
| 1184.15.39051 Boehringer Ingelheim Investigational Site | Florence | Italy |
| 1184.15.37154 Boehringer Ingelheim Investigational Site | Balvi | Latvia |
| 1184.15.37152 Boehringer Ingelheim Investigational Site | Jelgava | Latvia |
| 1184.15.37153 Boehringer Ingelheim Investigational Site | Tukums | Latvia |
| 1184.15.37053 Boehringer Ingelheim Investigational Site | Klaipėda | Lithuania |
| 1184.15.31051 Boehringer Ingelheim Investigational Site | Breda | Netherlands |
| 1184.15.31054 Boehringer Ingelheim Investigational Site | Utrecht | Netherlands |
| 1184.15.31052 Boehringer Ingelheim Investigational Site | Zutphen | Netherlands |
| 1184.15.42153 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1184.15.42154 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1184.15.27051 | Bellville | South Africa |
| 1184.15.27052 | Cape Town | South Africa |
| 1184.15.27053 | Somerset West | South Africa |
| 1184.15.82051 Boehringer Ingelheim Investigational Site | Jeonju | South Korea |
| 1184.15.82052 Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| 1184.15.82053 Boehringer Ingelheim Investigational Site | Wŏnju | South Korea |
| 1184.15.46053 Boehringer Ingelheim Investigational Site | Boden | Sweden |
| 1184.15.46051 Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| Reset | Dec 17, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 15, 2024 | Nov 4, 2024 | |||
| Nov 29, 2024 | Dec 17, 2024 | |||
| Jun 18, 2026 |
| 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 |
| 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 |
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