PURPOSE: Chronic mucous hypersecretion is common in moderate-severe COPD and is associated with respiratory infections and AE-COPD. HFCWO is accomplished using a pneumatic vest to facilitate mucous clearance. We hypothesized that patients using HFCWO therapy would have fewer AE-COPD.
METHODS: We conducted a sham-controlled, double-masked parallel group trial (N=50) of HFCWO (30 minutes daily for 12 weeks). Subjects had doctor diagnosed COPD, FEV1/FVC ≤; 70%, ≥ 20 pk-yrs tobacco, age ≥ 45yrs, daily mucous production, ≥ 1 AE-COPD in past 6 mos. The primary outcome was rate of AE-COPD, (modified Winnipeg criteria assessed by weekly interview).
RESULTS: Subjects wer64% male, 80% white and means age 63 years. 26 received active HFCWO (A) and 24 received a sham device (S). AE-COPD were common during the12-week follow-up (92% A vs. 95% S, p=.65). The rate of AE-COPD was lower in A than S ( 4 vs. 5.5/12wks, p<.02 by Poisson regression). By 12-weeks, the % of subjects with daily phlegm production decreased in A (75 to 52%), but increased in S (54 to 67%)(p=.35 for difference). Coughing up phlegm was more likely to become easy or mild in A than S (29 vs. 20%, p=.71). Quality of life (St. George's) improved in both S (p=.02) and A (p=.04), though there were no significant differences between groups (−6 vs. −3, p=.38). Self-reported adherence (daily use) was somewhat lower for A than S (57 vs. 80 %, p=.28).
CONCLUSION: This pilot study of active HFCWO therapy showed a significant reduction in the rate of AE-COPD compared with use of a sham device. Although no significant differences were found for symptoms and quality of life, the direction of change suggests a potential treatment effect.
CLINICAL IMPLICATIONS: HFCWO is a promising therapy to prevent AE-COPD. A larger and/or longer trial is needed to confirm the efficacy of HFCWO to prevent AE-COPD.
DISCLOSURE: Gregory Diette, No Product/Research Disclosure Information; University grant monies none; Grant monies (from sources other than industry) The Centers for Medicare and Medicaid Services provided grant support for this study; Grant monies (from industry related sources) Hill-Rom, Inc. provided financial support for this study.; Shareholder n/a; Employee n/a; Fiduciary position (of any organization, association, society, etc, other than ACCP n/a; Consultant fee, speaker bureau, advisory committee, etc. none; Other none