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Table 1 Primary and Secondary Endpoints

From: Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3)

 

Time Point

Primary endpoint

 Time-to-first event:

Through 12 months

  Moderate or Severe COPD Exacerbations

Secondary endpoints

 Time-to-first event

Through 12 months

  Severe COPD exacerbations

  Respiratory-related hospitalizations

 Changes in quality of life

Through 12 months

  SGRQ-C

  CAT Responders

  SF-36 Change

 

 Changes in dyspnea

Through 12 months

  Transition Dyspnea Index (TDI)

 Changes in lung functiona

Through 12 months

  FEV1

  FVC

  RV

  1. aChanges in lung function are measured using spirometry (FEV1 and FVC) and plethysmography (RV). Abbreviations: CAT COPD assessment test; FEV1 forced expiratory volume in 1 s; FVC forced vital capacity; IC inspiratory capacity; SF-36 short form health survey; SGRQ-C St. George’s Respiratory Questionnaire COPD version; TLC total lung capacity; TDI transition dyspnea indexes; RV residual volume