Clareo Health | Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers
Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
Patients must have a diagnosis of COPD and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1\>30% and \< 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC \<70% at Visit 1
Male or female patients, 40 years of age or older.
Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Patients who have never smoked cigarettes must be excluded.
Patients must be able to perform technically acceptable pulmonary function tests according to ATS/ERS guidelines and maintain records in a paper diary
Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
You may not be if
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 and patients with chronic respiratory failure
History of cystic fibrosis
Clinically evident bronchiectasis
History of significant alcohol or drug abuse
Thoracotomy with pulmonary resection
Patients treated with oral or patch ß-adrenergics
Patients treated with oral corticosteroid medication at unstable doses or at doses in excess of 10mg prednisolone per day or equivalent
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 or patients currently in a pulmonary rehabilitation program
Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA
Pregnant or nursing women
Women of childbearing potential not using a highly effective method of birth control
Patient who have previously been randomized in this study or are currently participating in another study
Patients who are unable to comply with pulmonary medication restrictions prior to randomization
