Table 3 The STEP-UP trial exclusion criteria

1.

Any condition that would interfere with the completion of the study follow-up assessments, bronchoscopy, or that would adversely affect study outcome.

2.

FEV1 < 20% predicted

3.

DLCO < 20% predicted

4.

Body mass index (BMI) < 18 kg/m2 or > 32 kg/m2

5.

Pulmonary hypertension:

a) Peak systolic PAP > 45 mm Hg or Mean PAP > 35 mm Hg

b) Right heart catheter measurements will be considered definitive over echocardiogram measurements

6.

Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medical management and prescribed rehabilitation

7.

Homogeneous disease and/or with highly diseased lower lobes (Density - tissue to air ratio of <11%)

8.

Clinical significant bronchiectasis

9.

Pneumothorax or pleural effusions within previous 6 months

10.

Heart and/or lung conditions, stroke, heart failure, transplant, lung volume reduction or resection, bullectomy, or implantable cardiac defibrillator implant

11.

Recent COPD exacerbation in preceding 6 weeks, or > 3 COPD related hospitalizations requiring antibiotics in past 12 months

12.

Daily use of systemic steroids, > 5 mg prednisolone

13.

Single large bulla (defined as > 1/3 volume of the lobe) in upper lobe

14.

Coagulopathy or current use of anticoagulants