Phase 2
Completed N=154
Tiotropium Respimat Pharmacokinetic Study in COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01222533 ↗
Enrolled (actual)
154
Serious AEs
1.4%
Results posted
Dec 2012
Primary outcomePrimary: Maximum Plasma Concentration at Steady-state (Cmax,ss) — 2.81; 5.07; 10.5; 12.9 pg/ml — p=0.4423
Summary
The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration at Steady-state (Cmax,ss) |
2.81; 5.07; 10.5; 12.9 | 0.4423 |
| PRIMARY Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss) |
10.0; 12.8; 22.1; 28.4 | 0.8683 |
| SECONDARY Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period |
1.345; 1.432; 1.446; 1.466; 1.473 | <0.0001 sig |
| SECONDARY FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period |
1.371; 1.535; 1.556; 1.562; 1.567 | <0.0001 sig |
| SECONDARY FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period |
1.366; 1.521; 1.546; 1.553; 1.558 | <0.0001 sig |
| SECONDARY Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period |
3.116; 3.254; 3.304; 3.352; 3.351 | <0.0001 sig |
| SECONDARY FVC AUC0-6h at the End of Each Treatment Period |
3.153; 3.436; 3.472; 3.488; 3.483 | <0.0001 sig |
| SECONDARY FVC AUC0-3h at the End of Each Treatment Period |
3.140; 3.421; 3.465; 3.479; 3.480 | <0.0001 sig |
| SECONDARY FEV1 at Each Planned Time at the End of Each Treatment Period |
1.349; 1.436; 1.450; 1.470; 1.477; 1.366 | — |
| SECONDARY FVC at Each Planned Time at the End of Each Treatment Period |
3.118; 3.255; 3.307; 3.356; 3.351; 3.131 | — |
| SECONDARY Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss) |
2.08; 3.16; 6.13; 7.79 | — |
| SECONDARY Time to Maximum Plasma Concentration at Steady-state (Tmax,ss) |
0.100; 0.0830; 0.117; 0.117 | — |
| SECONDARY Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss) |
88.7; 177; 387; 522 | — |
| SECONDARY Pre-dose Plasma Concentration at Steady-state (Cpre,ss) |
1.57; 1.39; 1.60; 1.71 | — |
| SECONDARY Renal Clearance at Steady-state (CL R,0-6h,ss) |
256; 277; 307; 310 | — |
| SECONDARY Minimum Plasma Concentration at Steady-state (Cmin,ss) |
1.16; 1.25; 1.57; 1.76 | — |
Eligibility Criteria
Inclusion criteria
- All patient must sign an informed consent consistent with IInternational Conference on Harmonisation- Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to any study-related procedures, including medication washout and restrictions.
- Relatively stable, moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)
- Current or ex-smokers (smoking history of at least 10 pack years)
- Able to perform lung function tests
- Able to use study inhalers
Exclusion criteria
- Significant diseases other than COPD
- Recent myocardial infarction, unstable or life-threatening cardiac arrhythmia, hospitalisation for cardiac failure.
- Malignancy requiring resection, radiation therapy or chemotherapy within the last 5 years
- History of asthma, life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis 5 Active tuberculosis
- History of alcohol or drug abuse 7. Pulmonary resection 8. Recent completion of a pulmonary rehabilitation program or current participation which will not be continued 9. Daytime oxygen therapy for more than 1 hour per day. 10. Use of other investigational drugs, restrictions on the use of some respiratory medications during the study period.
- Current participation in another clinical trial 12. Pregnant or nursing women 13. Women of childbearing potential not using a highly effective method of contraception (e.g: implants, injectable, oral contraceptives)
Data sourced from ClinicalTrials.gov (NCT01222533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.