ASPIRE 2015.
| Methods | Randomized clinical trial. 3:2 block randomizations stratified by study site. Allocation concealment not mentioned. Follow‐up until 6 months. | |
| Participants | Baseline Age: treatment 65 years versus control 64 years Participants: treatment n = 61 versus control n = 34 % female: 41% Disease distribution: heterogeneous Baseline score on outcomes: Median FEV1 % predicted (IQR): treatment 29% (23 to 35) versus control 30% (27 to 38) Median QoL in units total score SGRQ (IQR): treatment 54 units (46 to 65) versus control 58 units (45 to 74) Median RV % predicted (IQR): treatment 200% (168 to 231) versus control 179% (168 to 215) Median TLC % predicted (IQR): treatment 124% (115 to 139) versus control 120% (108 to 133) Median DLCO % predicted (IQR): treatment 33% (26 to 39) versus control 36% (18 to 46) Median PaO2 in mm Hg (IQR): treatment 70 mm Hg (64 to 78) versus control 71 mm Hg (63 to 78) Median PaCO2 in mm Hg (IQR): treatment 41 mm Hg (37 to 45) versus control 41 mm Hg (37 to 44) Median 6MWD in meters (IQR): treatment 313 m (236 to 363) versus control 293 m (247 to 420) |
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| Interventions | Intervention: AeriSeal + optimal medical care. Control: optimal medical care All participants were on or completed optimal medical care |
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| Outcomes | ‐ Forced expiratory volume in one second (FEV1) ‐ St. George Respiratory Questionnaire (SGRQ) ‐ Medical Research Council Dyspnea score (mMRC) ‐ 6‐minute walk test (6MWT) | |
| Notes | Aeris Therapeutics funded the study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomisation sequence was computer‐generated in blocks of five, stratified by site" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As per the FDA mandate, a sham procedure was not used. Open‐label study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Those conducting pulmonary function tests, 6MWD and questionnaires were blinded" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported: balanced between groups |
| Selective reporting (reporting bias) | Low risk | Protocol available as supplementary material |
| Other bias | High risk | High: study terminated early due to 'business reasons' |