This randomized controlled trial enrolled 113 patients with moderate to severe COPD (FEV1/forced vital capacity <0.70 and FEV1 ≤60% predicted) and disabling breathlessness (mMRC score ≥2) at the Westmead Breathlessness Service. Participants were assigned to an 8-week intervention involving breathing techniques, handheld fan use, exercise, energy conservation, and dietetic advice, or to an 8-week wait-list control group.
The primary outcome was change in the Chronic Respiratory Questionnaire (CRQ) Mastery of breathlessness subscale. The intervention group showed a clinically meaningful improvement, with an effect size of 0.5 units (95% CI 0.2 to 0.8; p=0.0262) compared to control. Secondary outcomes also improved: CRQ-Dyspnoea (0.4 units, 95% CI 0.1 to 0.7; p=0.005), CRQ-Fatigue (0.4 units, 95% CI 0.1 to 0.7; p=0.014), exertional breathlessness intensity (-0.8 units, 95% CI -1.4 to -0.2; p=0.013), and breathlessness unpleasantness (-1.2 units, 95% CI -1.7 to -0.6; p=0.001).
Safety and tolerability data were not reported. The study had an 8-week follow-up period. Key limitations include the lack of reported adverse events, the specific population (moderate to severe COPD with disabling breathlessness), and the setting at a single breathlessness service, which may limit generalizability.
Practice relevance is restrained; the intervention is non-pharmacologic and may be considered as an adjunct to standard care, but the evidence is from a single trial with short-term follow-up. Causality is supported by the randomized design, but the certainty is limited by the unreported safety data and single-center setting.
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BACKGROUND: Chronic obstructive pulmonary disease (COPD) is an often-progressive respiratory disease associated with disabling breathlessness. Breathlessness intervention services (BIS), which coach patients to self-manage breathlessness using non-pharmacological strategies, are effective in a variety of populations, including those with cancer and serious respiratory disease. This study aimed to compare the impact of the Westmead Breathlessness Service in people with moderate to severe COPD.
METHODS: We analysed 113 participants randomised (1:1) with moderate/severe COPD (forced expiratory volume in 1 s (FEV)/forced vital capacity <0.70 and FEV ≤60% predicted) and disabling breathlessness (modified Medical Research Council (mMRC) Breathlessness Score ≥2) to either an 8-week intervention involving breathing techniques, handheld fan use, exercise, energy conservation, dietetic advice (n=54) or 8-week wait-list control group (n=59). The primary outcome was change in Chronic Respiratory Questionnaire (CRQ) Mastery of breathlessness subscale. Secondary outcomes included change in other CRQ subscales (Fatigue, Emotion and Dyspnoea), exertional breathlessness intensity/unpleasantness (0-10 Numerical Rating Scale Score), anxiety and depression. Difference in change over 8 weeks between groups was compared using ANCOVA; p<0.05 statistically significant.
FINDINGS: Participants were aged 70.9 (±8.5) years, 50% female, mean FEV =0.8 L (±0.3 L; 34% predicted), mMRC Breathlessness Score 3 (IQR 3-4). CRQ-Mastery improved following intervention compared with control (between-group difference 0.5 units; 95% CI 0.2 to 0.8; p=0.0262) using modified intention-to-treat analysis. Better CRQ-Dyspnoea and CRQ-Fatigue were seen in the intervention group (between-group difference-CRQ-Dyspnoea 0.4 units; CI 0.1 to 0.7; p=0.005, and CRQ-Fatigue 0.4 units; CI 0.1 to 0.7; p=0.014). Exertional breathlessness intensity (difference -0.8 units; CI -1.4 to -0.2; p=0.013) and breathlessness unpleasantness (difference -1.2 units; CI -1.7 to -0.6; p=0.001) also improved.
INTERPRETATION: An 8-week BIS improved CRQ-Mastery, Dyspnoea and Fatigue, exertional breathlessness intensity and unpleasantness in people with severe COPD.