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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-000207-15 |
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The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium+Salmeterol | Drug | |||
| Salmeterol | Drug | |||
| Tiotropium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC0-∞ ) of tiotropium in plasma | 16 weeks | |
| Maximum measured concentration of tiotropium in plasma (Cmax) | 16 weeks | |
| Amount of tiotropium that was eliminated in urine (Ae0-8) from time point 0 to 8 hours post-inhalation | 16 weeks | |
| AUC0-∞ of salmeterol in plasma | 16 weeks | |
| Cmax salmeterol in plasma | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve (AUCt1-t2) of tiotropium and salmeterol in plasma over the time interval t1 to t2 for time intervals 0 to 4, 0 to 6, and 0 to 8 hours after inhalation (AUC0-4, AUC0-6, and AUC0-8) | 16 weeks | |
| Time from dosing to the maximum concentration of tiotropium and salmeterol in plasma (tmax) |
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Inclusion Criteria:
COPD patients of >= 40 years old with moderate to severe COPD who are current or ex-smokers with a smoking history of at least 10 pack-years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1184.24.32001 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||||
| 1184.24.32002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41134080 | Derived | Parigi TL, Nardone OM, Lisa M, Massimino L, Gabbiadini R, Innocenti T, Bertani L, Del Gaudio A, Florez P, Bertin L, Barberio B, Hupe M, Lopetuso L, Allocca M, D'Amico F, Furfaro F, Zilli A, Fiorino G, Ungaro F, Castiglione F, Savarino E, Dragoni G, Scaldaferri F, Armuzzi A, Peyrin-Biroulet L, Jairath V, Pizarro TT, Danese S. The Impact of E-Cigarettes and Heat-Not-Burn Tobacco on Postoperative Recurrence of Crohn's Disease: A Multicenter International Study. Am J Gastroenterol. 2025 Oct 24. doi: 10.14309/ajg.0000000000003810. Online ahead of print. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 |
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| 16 weeks |
| Terminal rate constant in plasma (λz) | 16 weeks |
| Terminal half-life (t½) of tiotropium and salmeterol in plasma) | 16 weeks |
| Mean residence time (MRTih) of tiotropium and salmeterol in the body after inhalational administration | 16 weeks |
| Apparent clearance (CL/F) of tiotropium and salmeterol in plasma after extravascular administration) | 16 weeks |
| Apparent volume of distribution (Vz/F) during the terminal phase (λz) following an extravascular dose) | 16 weeks |
| Amount of tiotropium that is eliminated in urine from the time point t1 to time point t2 (Aet1-t2) (Ae0-2, Ae2-4, Ae4-8, Ae0-8) | 16 weeks |
| Fraction of tiotropium eliminated in urine from time point t1 to time point t2 (fet1-t2) (fe0-2, fe2-4, fe4-8, fe0-8) | 16 weeks |
| Renal clearance of tiotropium from the time point t1 until the time point t2 (CLR,t1-t2) (CLR,0-2, CLR, 2-4, CLR,4-8, CLR,0-8) | 16 weeks |
| All adverse events | 20 weeks |
| Blood pressure (seated) recorded in conjunction with 12-lead ECG recordings pre-dose and following the morning dose of randomized treatment | 20 weeks |
| Number of patients with abnormalities in routine blood chemistry, haematology and urinalysis | 16 weeks |
| Trough forced expiratory volume in one second (FEV1) | 16 weeks |
| Trough forced vital capacity (FVC) | 16 weeks |
| FEV1 area under the curve 0 to 8 hours (FEV1 AUC0-8h) | 16 weeks |
| FVC area under the curve 0 to 8 hours (FVC AUC0-8h) | 16 weeks |
| Individual FEV1and FVC measurements at each time point at the end of each 4-week treatment period. | 16 weeks |
| Hasselt |
| Belgium |
| 1184.24.31001 Boehringer Ingelheim Investigational Site | Heerlen | Netherlands |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |