OBJECTIVES

: Patient-reported outcomes (PRO) are essential in chronic obstructive pulmonary disease (COPD) to evaluate symptoms, impact on daily life and treatment response. This review aims to summarize PRO endpoints from main COPD trials, and inform on existing gaps.

METHODS

: A search was conducted in clinicaltrials.gov to identify COPD clinical trials and related PRO endpoints. It was restricted to completed phase III and IV of main COPD drugs (Indacaterol, roflumilast, aclidinium, umeclidinium, fluticasone, glycopyrronium, olodaterol, tiotropium, vilanterol, salmeterol, formoterol, budesonide, beclomethasone) and/or their combinations.

RESULTS

: Results (n=88) presented are mutually inclusive. Health-related quality of life (HRQoL) measured mainly by St. George’s respiratory questionnaire (SGRQ; n=65), followed by COPD Assessment Test (CAT; n=7), Capacity of Daily Living during Morning (CDLM; n=2), Cough and Sputum Assessment Questionnaire (CASA-Q; n=2), Leicester Cough Questionnaire (LCQ; n=1) and Clinical COPD questionnaire (CCQ; n=1).

Symptom-based measures like Exacerbation of Chronic Pulmonary Disease Tool (EXACT-PRO; n=3); its respiratory subscale (ERS; n=4), Shortness of Breath Questionnaire (SOBQ; n=2), Shortness of Breath with Daily Activities (SOBDA; n=4), Chronic Respiratory Questionnaire Self-Administered Standardized (CRQ-SAS; n=4) were reported. Early Morning and Nighttime (EMSCI and NISCI) Symptoms of COPD Instrument and Global Chest Symptoms Questionnaire were utilized in one study each. Basal/transitional dyspnea Indexes (BDI/TDI) used (n=53) to determine severity and impact of dyspnea. Non-validated (Likert scale-based) symptom measures reported in 25 studies

CONCLUSIONS

: There is an acceptable coverage of overall HRQoL and symptoms. Despite availability of measures covering affected areas like sleep, fatigue, treatment burden etc., a gap exists owing to lack of their use. It is difficult to capture improvement/deterioration in such domains by total or subscale scores of routine COPD instruments. While, it is important to measure overall HRQoL and symptoms, instruments addressing directly the impact of symptoms on HRQoL should also be considered. This will contribute to comprehensive patient centered assessment in trials.