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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01040793
Eligibility Criteria:
Inclusion criteria:
1. Signed informed consent prior to participation.
2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) \<80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of \< 70% at Visit 1.
3. Male or female between 40 and 75 years of age.
4. Current or ex-smokers with smoking history of more than 10-pack years.
5. Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.
6. Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler.
Exclusion criteria:
1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN.
2. Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
3. Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute).
4. Patients with a 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, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.
5. Patients who have undergone thoracotomy with pulmonary resection.
6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
7. Patients who regularly use daytime oxygen for more than one hour per day.
8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
9. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.
10. Pregnant or nursing women.
11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01040793
Study Brief:
Protocol Section:
NCT01040793