Table 5.

Future Steps in the Design and Conduct of Intervention Studies of Young Patients with COPD or Those at Risk with Pre-COPD

	Young Patients with COPD	Pre-COPD
Potential outcomes to explore	• Rate of FEV1 decline • Time to first COPD exacerbation	• Time to onset of COPD • Time to worsening in CAT (1 point) or SGRQ (4 points)
Study duration	• 3 yr	• 3–5 yr
Interim analysis at 6–12 mo (to assess dropping therapy arms and/or extending trial duration/increase sample size)	• Rate of FEV1 decline • Time to first COPD exacerbation • CAT change • Composite outcomes*	• Rate of FEV1 decline • CAT change • E-RS: COPD • Others (impulse oscillometry and/or lung imaging: airways disease parameters; HCRU events; CompEx COPD) • Composite outcomes*
Potential intervention arms	Currently approved medications for COPD	Currently approved medications for COPD as well as novel agents capable of modifying disease progression
Placebo control	No (as these are currently approved medications for airflow limitation with no age limits)	Yes (as these medications are not approved for this indication)
Study population as per the definition in the text (plus some other potential characteristics to consider in the study design to enrich the population studied)	• CAT score >10 • A respiratory HCRU event in 2 of the past 3 yr • Biomarker enrichment†	• Individuals with NOCB symptoms as defined using the CAT or SGRQ • A respiratory HCRU event in the past 24 mo • Subjects with rapid FEV1 decline • Biomarker enrichment†

Definition of abbreviations: CAT = COPD Assessment Test; COPD = chronic obstructive pulmonary disease; E-RS = Evaluating Respiratory Symptoms in COPD tool; HCRU = health care resource utilization; NOCB = nonobstructive chronic bronchitis; SGRQ = St. George’s Respiratory Questionnaire.

^*Such as clinically important deterioration examining time to FEV₁ decline, exacerbation, or symptom worsening.

^† Circulating eosinophils and microbial assessments (see the main text).