A Study Comparing the Effectiveness of Tiotropium and Olodaterol in Fixed Dose Combination Over Tiotropium Alone in Reducing Moderate to Severe Wosening of Symptoms in Patients with Severe to Very Severe Chronic Obstructive Pulmonary Disease

Overview

About this study

The overall purpose of this study is to assess the effect of once daily tiotropium and olodaterol in a fixed dose combination compared to tiotropium alone on worsening symptoms in patients with severe to very severe COPD (chronic obstructive pulmonary disease ).

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

  • Male or female patients, 40 years of age or older
  • Diagnosis of COPD with a documented post-bronchodilator forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/FVC (Forced vital capacity) <70% at visit 1
  • Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization
  • Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1
  • Current or ex-smokers with a smoking history of more than 10 pack years

Exclusion Criteria

  • Significant disease other than COPD
  • Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN regardless of clinical condition ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator)
  • Current documented diagnosis of asthma
  • For allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
  • A diagnosis of thyrotoxicosis
  • A history of myocardial infarction within 6 months of screening visit
  • Life-threatening cardiac arrhythmia
  • Known active tuberculosis
  • Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed)
  • A history of cystic fibrosis
  • Clinically relevant bronchiectasis
  • Severe emphysema requiring endobronchial interventions within 6 months prior to screening
  • A history of significant alcohol or drug abuse in the opinion of the investigator
  • Have undergone thoracotomy with pulmonary resection
  • Treated with oral or patch ß-adrenergics
  • Treated with oral corticosteroid medication at unstable doses
  • Treated with antibiotics for any reasons within 4 weeks of screening visit
  • Treated with PDE4 inhibitors within 3 months of screening visit
  • Have taken an investigational drug within one month or six half-lives
  • Pregnant or nursing women
  • Women of childbearing potential not using a highly effective method of birth control

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-20179700

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