A Study of the Safety and Effectiveness of Tiotropium and Olodaterol in a Fixed Dose Combination for Treatment of Chronic Obstructive Pulmonary Disease

Overview

About this study

The overall objective of this study is to assess the effectiveness and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol  (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Diagnosis of chronic obstructive pulmonary disease.
  • Relatively stable airway obstruction with post FEV1 < 80% predicted normal and post FEV1/FVC <70%
  • Male or female patients
  • Age 40 years or older
  • Smoking history of more than 10 pack years

Exclusion Criteria

  • Significant disease other than COPD
  • Clinically relevant abnormal lab values.
  • History of asthma.
  • Diagnosis of thyrotoxicosis
  • Diagnosis of paroxysmal tachycardia
  • History of myocardial infarction within 1 year of screening visit
  • Unstable or life-threatening cardiac arrhythmia
  • Hospitalization for heart failure within the past year
  • Known active tuberculosis.
  • Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
  • History of life-threatening pulmonary obstruction.
  • History of cystic fibrosis
  • Clinically evident bronchiectasis
  • History of significant alcohol or drug abuse
  • Thoracotomy with pulmonary resection
  • Oral ß-adrenergics
  • Oral corticosteroid medication at unstable doses
  • Regular use of daytime oxygen therapy for more than one hour per day
  • Pulmonary rehabilitation program in the six weeks prior to the screening visit
  • Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
  • Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
  • Pregnant or nursing
  • Women of childbearing potential not using a highly effective method of birth control
  • Patients who are unable to comply with pulmonary medication restrictions

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul Scanlon, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20311338

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