Tiotropium and Salmeterol PK Study in COPD Patients

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Registration Number: NCT00673478

Lead Sponsor: Boehringer Ingelheim

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Trough forced vital capacity (FVC)	16 weeks

Trial Locations

Locations (3): 1184.24.32001 Boehringer Ingelheim Investigational Site
🇧🇪
Genk, Belgium
1184.24.32002 Boehringer Ingelheim Investigational Site
🇧🇪
Hasselt, Belgium
1184.24.31001 Boehringer Ingelheim Investigational Site
🇳🇱
Heerlen, Netherlands