Tiotropium and Salmeterol PK Study in COPD Patients
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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) [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]
Eligibility Criteria
Criteria
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:
-
Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
-
History of asthma
-
Malignancy requiring treatment within past 5 years
-
Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
-
Known active tuberculosis
-
Pregnant or nusing women
-
Known hypersensitivity to components of the study medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1184.24.32001 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||
| 2 | 1184.24.32002 Boehringer Ingelheim Investigational Site | Hasselt | Belgium | ||
| 3 | 1184.24.31001 Boehringer Ingelheim Investigational Site | Heerlen | Netherlands |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1184.24
- EudraCT 2007-000207-15