Tiotropium and Salmeterol PK Study in COPD Patients

Boehringer Ingelheim50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium+SalmeterolDRUG

SalmeterolDRUG

TiotropiumDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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: 1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure 2. History of asthma 3. Malignancy requiring treatment within past 5 years 4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis 5. Known active tuberculosis 6. Pregnant or nusing women 7. Known hypersensitivity to components of the study medication

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

Outcomes

Primary Outcomes

Area under the concentration-time curve (AUC0-∞ ) of tiotropium in plasma

Time frame: 16 weeks

Maximum measured concentration of tiotropium in plasma (Cmax)

Time frame: 16 weeks

Amount of tiotropium that was eliminated in urine (Ae0-8) from time point 0 to 8 hours post-inhalation

Time frame: 16 weeks

AUC0-∞ of salmeterol in plasma

Time frame: 16 weeks

Cmax salmeterol in plasma

Time frame: 16 weeks

Secondary Outcomes

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)

Time frame: 16 weeks

Time from dosing to the maximum concentration of tiotropium and salmeterol in plasma (tmax)

Time frame: 16 weeks

Terminal rate constant in plasma (λz)

Time frame: 16 weeks

Terminal half-life (t½) of tiotropium and salmeterol in plasma)

Time frame: 16 weeks

Mean residence time (MRTih) of tiotropium and salmeterol in the body after inhalational administration

Time frame: 16 weeks

Apparent clearance (CL/F) of tiotropium and salmeterol in plasma after extravascular administration)

Data from ClinicalTrials.gov

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