The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

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/ forced vital capacity (FVC) \<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.

Criterios de exclusión

Significant disease other than COPD.
Clinically relevant abnormal baseline haematology, blood chemistry or creatinine \> x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.)
Current documented diagnosis of asthma. For patients with 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.
Patients with 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.
Patients who have undergone thoracotomy with pulmonary resection
Patients being treated with oral or patch ß-adrenergics.
Patients being treated with oral corticosteroid medication at unstable doses
Patients being treated with antibiotics for any reasons within 4 weeks of screening visit
Patients being treated with PDE4 inhibitors within 3 months of screening visit
Patients who 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.

Ubicaciones

1237.19.54015 Boehringer Ingelheim Investigational Site

Bahía Blanca, Argentina

1237.19.54014 Boehringer Ingelheim Investigational Site

Berazategui, Argentina

1237.19.54003 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1237.19.54004 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1237.19.54007 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1237.19.54011 Boehringer Ingelheim Investigational Site

Ciudad de Buenos Aires, Argentina

1237.19.54018 Boehringer Ingelheim Investigational Site

Ciudad de Buenos Aires, Argentina

1237.19.54010 Boehringer Ingelheim Investigational Site

La Plata, Argentina

1237.19.54012 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1237.19.54017 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1237.19.54019 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1237.19.54005 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

1237.19.54006 Boehringer Ingelheim Investigational Site

Quilmes, Argentina

1237.19.54013 Boehringer Ingelheim Investigational Site

Rosario, Argentina

1237.19.54016 Boehringer Ingelheim Investigational Site

San Isidro, Argentina

1237.19.54001 Boehringer Ingelheim Investigational Site

San Miguel de Tucumán, Argentina

1237.19.54002 Boehringer Ingelheim Investigational Site

San Miguel de Tucumán, Argentina

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

olodaterol

tiotropium

tiotropium

Ubicaciones

1237.19.54015 Boehringer Ingelheim Investigational Site

1237.19.54014 Boehringer Ingelheim Investigational Site

1237.19.54003 Boehringer Ingelheim Investigational Site

1237.19.54004 Boehringer Ingelheim Investigational Site

1237.19.54007 Boehringer Ingelheim Investigational Site

1237.19.54011 Boehringer Ingelheim Investigational Site

1237.19.54018 Boehringer Ingelheim Investigational Site

1237.19.54010 Boehringer Ingelheim Investigational Site

1237.19.54012 Boehringer Ingelheim Investigational Site

1237.19.54017 Boehringer Ingelheim Investigational Site

1237.19.54019 Boehringer Ingelheim Investigational Site

1237.19.54005 Boehringer Ingelheim Investigational Site

1237.19.54006 Boehringer Ingelheim Investigational Site

1237.19.54013 Boehringer Ingelheim Investigational Site

1237.19.54016 Boehringer Ingelheim Investigational Site

1237.19.54001 Boehringer Ingelheim Investigational Site

1237.19.54002 Boehringer Ingelheim Investigational Site

Patrocinadores