Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis

Authors


  • This research was coordinated through the University of Colorado Denver and The Children's Hospital, Aurora Colorado. Participating institutions are presented in the Appendix.

Abstract

Rationale

Airway secretion clearance therapies are a cornerstone of cystic fibrosis care, however longitudinal comparative studies are rare. Our objectives were to compare three therapies [postural drainage and percussion: (postural drainage), flutter device (FD), and high frequency chest wall oscillation: (vest)], by studying (1) change in pulmonary function; (2) time to need for intravenous (IV) antibiotics, (3) use of pulmonary therapies, (4) adherence to treatment, (5) treatment satisfaction, and (6) quality of life.

Methods

Participants were randomly assigned to one of three therapies twice daily. Clinical outcomes were assessed quarterly over 3 years.

Results

Enrollment goals were not met, and withdrawal rates were high, especially in postural drainage (51%) and FD (26%), compared to vest (9%), resulting in early termination. FEV1 decline, time to need IV antibiotics, and other pulmonary therapies were not different. The annual FEF25–75% predicted rate of decline was greater in those using vest (P = 0.02). Adherence was not significantly different (P = 0.09). Overall treatment satisfaction was higher in vest and FD than in postural drainage (P < 0.05). Health-related quality of life was not different. The rate of FEV1 decline was 1.23% predicted/year.

Conclusions

The study was ended early due to dropout and smaller than expected decline in FEV1. Patients were more satisfied with vest and FD. The longitudinal decline in FEF25–75% was faster in vest; we found no other difference in lung function decline, taken together this warrants further study. The slow decline in FEV1 illustrates the difficulty with FEV1 decline as a clinical trial outcome. Pediatr Pulmonol. 2010; 45:291–300. © 2010 Wiley-Liss, Inc.

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