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. 2020 Feb 13;20:41. doi: 10.1186/s12890-020-1058-5

Table 2.

Inclusion Criteria

1 Participants aged ≥40 and ≤ 75 years at the time of consent.
2 Women of childbearing potential must have a negative pregnancy test (blood or urine) pre-treatment and agree not to become pregnant for the duration of the study.
3 Smoking history of at least 10 pack years.
4 Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the study. Negative nicotine test required, if participant is taking smoking cessation medication, patch, gum, etc., a quantitative test should be performed to assess if measured level of nicotine or cotinine is below study threshold(s).
5 Received a flu vaccination within the 12 months prior to consent and agrees to annual vaccinations for the duration of the study.
6 SpO2 ≥ 89% on room air at the time of screening.
7 CAT score ≥ 10 at the time of screening.
8 Diagnosis of COPD with 30% ≤ FEV1 < = 60% of predicted and FEV1/FVC < 70% (post-bronchodilator).
9 Documented history of ≥2 moderate COPD exacerbations or ≥ 1 severe COPD exacerbation leading to hospitalization in the 12 months prior to consent.
10 Documented history of taking at least LAMA and a LABA as regular respiratory maintenance medication for ≥12 months at the time of consent. Participants who have documented intolerance to LAMA and/or LABA but are taking a minimum of two regular respiratory maintenance medications (e.g., ICS/LABA) are eligible for participation. Participants who do not respond to LABA and LAMA maintenance inhaler therapy will be allowed to use nebulized bronchodilator therapy.
11 Recent participation in a formal pulmonary rehabilitation program should have occurred ≥3 months prior to consent; if participant is currently enrolled in a maintenance program, they agree to continue their current program through their 12-month follow-up visit.
12 Candidate for bronchoscopy in the opinion of the physician or per hospital guidelines. Examples of suitability of participant for bronchoscopy include, but are not limited to: cardiovascular fitness, ability of participant to be intubated, ability to oxygenate patient, absence of previously diagnosed high-grade tracheal obstruction, absence of uncorrectable coagulopathy (i.e. participant is unable to stop taking blood thinning medication, with the exception of aspirin, 7 days before and not restart until 7 days after the study procedure).
13 Willing, able, and agrees to complete all protocol required baseline and follow-up testing assessments including taking certain medications (e.g., azithromycin, prednisolone / prednisone).
14 Provided written informed consent using a form reviewed and approved by the IRB/EC.

Abbreviations: CAT COPD assessment test; FEV1 forced expiratory volume in 1 s; FVC forced vital capacity; ICS inhaled corticosteroids; IRB/EC Institutional review board/ethics committee; LABA long-acting beta agonists; LAMA long-acting muscarinic antagonists