Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Long-term High-flow Nasal Cannula Therapy in Patients With Stable COPD: a Prospective, Randomized Crossover Study
Brief Summary: This is a prospective, randomized crossover study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and hypercapnia who require home oxygen therapy (HOT). The total duration of subject participation will be 52 weeks, consisting of 12-week treatment period and 40-week continuation period. Subjects who satisfy all inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy plus HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current HOT. After treatment period, the willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment. The end of the study is defined as the treatment period or continuation period end date of the last participant, whichever is later. Subjects will primarily be assessed by the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24 and 52.


Options:
A: Arm Label: Treatment sequence I; Type: ACTIVE_COMPARATOR; Interventions: Drug: QVA149, Drug: Placebo | Arm Label: Treatment sequence II; Type: ACTIVE_COMPARATOR; Interventions: Drug: QVA149, Drug: Placebo | Intervention Type: DRUG; Name: QVA149; Assigned to Arm(s): Treatment sequence I, Treatment sequence II | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Treatment sequence I, Treatment sequence II
B: Arm Label: Indacaterol 300 μg followed by placebo; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 300 μg, Drug: Placebo | Arm Label: Placebo followed by indacaterol 300 μg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 300 μg, Drug: Placebo | Intervention Type: DRUG; Name: Indacaterol 300 μg; Assigned to Arm(s): Indacaterol 300 μg followed by placebo, Placebo followed by indacaterol 300 μg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Indacaterol 300 μg followed by placebo, Placebo followed by indacaterol 300 μg
C: Arm Label: Exercise intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Exercise intervention
D: Arm Label: Arm A (myAIRVO2® + HOT, HOT); Type: EXPERIMENTAL; Interventions: Device: High-flow nasal cannula therapy, Device: Home oxygen therapy (HOT) | Arm Label: Arm B (HOT, myAIRVO2® + HOT); Type: EXPERIMENTAL; Interventions: Device: High-flow nasal cannula therapy, Device: Home oxygen therapy (HOT) | Intervention Type: DEVICE; Name: High-flow nasal cannula therapy; Assigned to Arm(s): Arm A (myAIRVO2® + HOT, HOT), Arm B (HOT, myAIRVO2® + HOT) | Intervention Type: DEVICE; Name: Home oxygen therapy (HOT); Assigned to Arm(s): Arm A (myAIRVO2® + HOT, HOT), Arm B (HOT, myAIRVO2® + HOT)

Answer: D