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

Marci K. Sontag, Alexandra Quittner, Avani C. Modi, Joni M. Koenig, Don Giles, Christopher M. Oermann, Michael W. Konstan, Robert Castile, Frank J. Accurso

Research output: Contribution to journalArticle

31 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)291-300
Number of pages10
JournalPediatric Pulmonology
Volume45
Issue number3
DOIs
StatePublished - Mar 1 2010

Fingerprint

Cystic Fibrosis
Postural Drainage
Equipment and Supplies
Lung
Therapeutics
Chest Wall Oscillation
Quality of Life
Anti-Bacterial Agents
Percussion
Longitudinal Studies
Clinical Trials

Keywords

  • Chest wall oscillation
  • Cystic fibrosis
  • Drainage
  • Medication adherence
  • Patient dropouts
  • Postural

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Pulmonary and Respiratory Medicine

Cite this

Sontag, M. K., Quittner, A., Modi, A. C., Koenig, J. M., Giles, D., Oermann, C. M., ... Accurso, F. J. (2010). Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis. Pediatric Pulmonology, 45(3), 291-300. https://doi.org/10.1002/ppul.21179

Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis. / Sontag, Marci K.; Quittner, Alexandra; Modi, Avani C.; Koenig, Joni M.; Giles, Don; Oermann, Christopher M.; Konstan, Michael W.; Castile, Robert; Accurso, Frank J.

In: Pediatric Pulmonology, Vol. 45, No. 3, 01.03.2010, p. 291-300.

Research output: Contribution to journalArticle

Sontag, MK, Quittner, A, Modi, AC, Koenig, JM, Giles, D, Oermann, CM, Konstan, MW, Castile, R & Accurso, FJ 2010, 'Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis', Pediatric Pulmonology, vol. 45, no. 3, pp. 291-300. https://doi.org/10.1002/ppul.21179
Sontag, Marci K. ; Quittner, Alexandra ; Modi, Avani C. ; Koenig, Joni M. ; Giles, Don ; Oermann, Christopher M. ; Konstan, Michael W. ; Castile, Robert ; Accurso, Frank J. / Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis. In: Pediatric Pulmonology. 2010 ; Vol. 45, No. 3. pp. 291-300.
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