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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT03031769
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged 40 years or older.
2. Patient has diagnosis of COPD for 1 year or more.
3. Patient has at least one spirometry with COPD criteria, fixed ratio \<0.70 post BD, in previous 12 months
4. Patient is a current smoker or an ex-smoker with a smoking history of ≥ 10 pack- years.
5. Stable patients, as stated in medical records or patient reports during visit, defined as: without exacerbation treatment at study visit neither in the previous 2 months, and without changes in maintenance COPD treatment regimen over the preceding 2 months (avoid first consult patient)
6. Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
7. After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
1. Patient has diagnosis of sleep apnea syndrome or other chronic respiratory disease different from chronic obstructive diseases. (except for non-idiopathic pulmonary fibrosis and ACOS, only if the main diagnosis is COPD)
2. An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study
3. Patient is participating in an ongoing clinical trial that might, in the investigator's opinion, influence the assessment for SPACE study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
130 Years
Study:
NCT03031769
Study Brief:
Protocol Section:
NCT03031769