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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Paul Scanlon, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
.
CLS-20311338

Mayo Clinic Footer