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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02683668
Eligibility Criteria:
Inclusion Criteria:
1. COPD patients with FEV1/FVC \<70% predicted.
2. Mild (GOLD stage I: FEV1 \>80% pred.) to moderate (GOLD stage II: FEV1 50-80% pred.)
3. Aged 30 years onwards - there is no upper age limit as we do not want to exclude elderly patients as COPD is primarily a disease in the elderly population.
4. Have on-going symptoms or exercise limitation (determined by CAT score)
5. Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 2 months).
6. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
1. Subjects who lack the capacity to consent will not be recruited.
2. Current or past diagnosis of asthma.
3. Patients on concurrent oral bronchodilators (theophylline, PDE4 inhibitors) will not be included.
4. Patients on other LAMAs will not be included
5. History of any chronic respiratory diseases other than COPD.
6. History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study.
7. Clinical evidence of heart failure (NYHA class III-IV).
8. Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a lower respiratory tract infection in the previous four weeks).
9. Evidence of a respiratory exacerbation requiring emergency room treatment and/or hospitalisation within four weeks before screening.
10. Use of systemic (oral or intravenous) steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 12 months.
11. Participants with a known or suspected allergy, sensitivity or intolerance to the study drugs (this will be asked directly at the screening visit) or patients with a history of another drug allergy which, in the opinion of the Unit Physician, contraindicates his/her participation in the study.
12. Patients with known or suspected cardiac rhythm disorders
13. Patients treated with beta-blockers in the week preceding the screening visit and during the study period.
14. Females who are pregnant or lactating or are likely to become pregnant during the trial. (a urine pregnancy test will be performed. Women of childbearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions.
15. Patients who have evidence of alcohol or substance abuse.
16. Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT02683668
Study Brief:
Protocol Section:
NCT02683668