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Completed

NCT Number: NCT00673478

Tiotropium and Salmeterol PK Study in COPD Patients

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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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1184.24.32001 Boehringer Ingelheim Investigational Site, Genk, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium+Salmeterol

Drug

Salmeterol

Drug

Tiotropium

Drug

Primary outcomes

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

    Time frame: 16 weeks

  2. Maximum measured concentration of tiotropium in plasma (Cmax)

    Time frame: 16 weeks

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

    Time frame: 16 weeks

  4. AUC0-∞ of salmeterol in plasma

    Time frame: 16 weeks

  5. Cmax salmeterol in plasma

    Time frame: 16 weeks

Secondary outcomes

  1. 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

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

    Time frame: 16 weeks

  3. Terminal rate constant in plasma (λz)

    Time frame: 16 weeks

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

    Time frame: 16 weeks

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

    Time frame: 16 weeks

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

    Time frame: 16 weeks

  7. Apparent volume of distribution (Vz/F) during the terminal phase (λz) following an extravascular dose)

    Time frame: 16 weeks

  8. 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)

    Time frame: 16 weeks

  9. Fraction of tiotropium eliminated in urine from time point t1 to time point t2 (fet1-t2) (fe0-2, fe2-4, fe4-8, fe0-8)

    Time frame: 16 weeks

  10. 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)

    Time frame: 16 weeks

  11. All adverse events

    Time frame: 20 weeks

  12. Blood pressure (seated) recorded in conjunction with 12-lead ECG recordings pre-dose and following the morning dose of randomized treatment

    Time frame: 20 weeks

  13. Number of patients with abnormalities in routine blood chemistry, haematology and urinalysis

    Time frame: 16 weeks

  14. Trough forced expiratory volume in one second (FEV1)

    Time frame: 16 weeks

  15. Trough forced vital capacity (FVC)

    Time frame: 16 weeks

  16. FEV1 area under the curve 0 to 8 hours (FEV1 AUC0-8h)

    Time frame: 16 weeks

  17. FVC area under the curve 0 to 8 hours (FVC AUC0-8h)

    Time frame: 16 weeks

  18. Individual FEV1and FVC measurements at each time point at the end of each 4-week treatment period.

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Open-label, 4-way Crossover Study to Characterize the Pharmacokinetics, Safety and Efficacy of FDC Tiotropium/Salmeterol, Tiotropium, Salmeterol and a Free Combination of Tiotropium Plus Salmeterol Following 4-week Treatment Periods in Patients With COPD.

Important dates

Study start
2008
Primary completion
2009
First posted
May 7, 2008
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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