Abstract | BACKGROUND: METHODS: Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second. RESULTS: Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes. CONCLUSIONS: HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00181285.
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Authors | Amit K Mahajan, Gregory B Diette, Umur Hatipoğlu, Andrew Bilderback, Alana Ridge, Vanessa Walker Harris, Vijay Dalapathi, Sameer Badlani, Stephanie Lewis, Jeff T Charbeneau, Edward T Naureckas, Jerry A Krishnan |
Journal | Respiratory research
(Respir Res)
Vol. 12
Pg. 120
(Sep 10 2011)
ISSN: 1465-993X [Electronic] England |
PMID | 21906390
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Topics |
- Acute Disease
- Adult
- Asthma
(physiopathology, therapy)
- Chest Wall Oscillation
(methods)
- Cohort Studies
- Disease Progression
- Humans
- Middle Aged
- Pulmonary Disease, Chronic Obstructive
(physiopathology, therapy)
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