Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT02030535
Eligibility Criteria:
Inclusion criteria:
* 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).
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02030535
Study Brief:
Protocol Section:
NCT02030535