N/A
Completed N=40
Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute
Source: ClinicalTrials.gov NCT00560105 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight — 11.9; 14.5; 14.4; 14.3 g
Summary
This is an eight-week, randomized, controlled, two arm parallel study. The study consists of, a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0, 1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum samples will be collected and weighed at each clinic visit. In addition to clinic visits, subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation will include adverse event surveillance, and St. Georges Respiratory questionnaire.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight |
11.9; 14.5; 14.4; 14.3; 14.5; 14.2 | — |
| SECONDARY FEV1 - Baseline and Device Comparisons |
1.43; 1.38; 1.49; 1.44 | — |
| SECONDARY Quality of Life Questionnaire/Daily Diary |
45.5; 51.9; 45.0; 47.2 | — |
| SECONDARY Change in CCQ Score |
2.53; 3.24; 2.29; 2.82 | — |
Eligibility Criteria
Inclusion Criteria
- Age of over 40 with COPD
Exclusion Criteria
- Children,
- New mothers; and
- Women intending to become pregnant
Data sourced from ClinicalTrials.gov (NCT00560105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.