Baseline Eligibility Criteria. Any study candidate who meets the screening eligibility criteria and has successfully completed a supervised pulmonary rehabilitation program may have clinical testing to support assessment of the baseline eligibility criteria (Appendix 7). The baseline eligibility determination must be made < 120 days following the screening eligibility determination. It is recommended that baseline eligibility testing be conducted sequentially in the order listed in Section 14.0. Study candidates who meet the screening and baseline eligibility criteria may be considered for study enrollment. Study candidates meeting the screening and baseline eligibility criteria will be required to have signed the Study Informed Consent Form (Appendix 8) or similar prior to undergoing the bronchoscopy procedure to assess study procedure eligibility. Study candidates who have met the screening and baseline eligibility criteria but who are no longer interested in participating in the study or who do not sign the Study Informed Consent Form will be recorded on the screening log. Study-related testing should not be conducted if the study participant is having an active COPD exacerbation at the time of baseline testing. If a study participant has a COPD exacerbation, the baseline testing should be postponed until the exacerbation is resolved as determined by the site principal investigator.
Baseline Eligibility Criteria. Baseline Inclusion Criteria 1 Completed a supervised pulmonary rehabilitation program less than equal to 6 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 6 months prior 2 Baseline evaluation occurred ≤ 120 days after screening exam 3 Signed written informed consent to participate in study using a form that was reviewed and approved by the IRB 4 Continued nonsmoking between initial screening and baseline exams 5 Willing and able to complete protocol required study follow-up assessments and procedures 6 FEV1 between 15% and 45% of predicted value at baseline exam 7 Post-rehabilitation 6-minute walk distance between 100 meters and 500 meters at baseline exam 8 Current Pneumococcus vaccination 9 Current Influenza vaccination Baseline Exclusion Criteria 10 Myocardial infarction or diagnosis of congestive heart failure between screening and baseline exams 11 Fever or other clinical evidence of active infection at baseline exam 12 Two or more COPD exacerbation episodes between screening and baseline exams 13 Two or more pneumonia episodes between screening and baseline exams Investigator Name: Institution: Site ID# Participant ID: Telephone: Dear Patient: You are being invited to participate in a clinical study involving research. This Informed Consent Letter describes the study and your role as a participant. If you choose to consider taking part in the study you must read this form carefully. You are urged to discuss any questions you have about the study with your physician and/or the hospital’s research staff. Persons who participate in a research study are entitled to certain rights. These rights include, but are not limited to, your right to: • Be informed of the nature and purpose of the medical experiment (ie. study); • Be given an explanation of the procedures to be followed in the study, and information about the drugs or devices to be used; • Be given a description of any discomforts and risks that are reasonable to expect; • Be given an explanation of any benefits that are reasonable to expect; • Be given information about other appropriate treatments that might be given to you and information about their risks and benefits; • Be informed of the medical treatments, if any, that are available to you if complications should arise after the investigational (ie. study) procedure; • Be given an opportunity to ask questions concerning the study or the pr...
