COPD
Conditions
Keywords
COPD
Brief 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.
Detailed description
No further details
Interventions
DEVICELung Flute
8 weeks home use, twice daily
DEVICEAcapella
8 weeks home use, twice daily
Sponsors
Medical Acoustics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of over 40 with COPD
Exclusion criteria
* Children, * New mothers; and * Women intending to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | 8 weeks | In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 - Baseline and Device Comparisons | 8 weeks | Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8. |
| Quality of Life Questionnaire/Daily Diary | 8 weeks | St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation) |
| Change in CCQ Score | 8 weeks | The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms. |
Countries
United States
Participant flow
Recruitment details
We recruited 45 subjects, of which 5 subjects either did not meet the initial inclusion/exclusion criteria (n=3) or did not meet the compliance criteria between the recruitment and randomization visit (n=2).
Pre-assignment details
Of the 40 subjects who were randomized, 20 each were randomized to the 2 devices. Of these 40 subjects, 37 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Acapella Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella® | 20 |
| Lung Flute Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella® | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | musculoskeletal chest discomfort with us | 1 | 2 |
Baseline characteristics
| Characteristic | Lung Flute | Acapella | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Continuous | 64.0 years STANDARD_DEVIATION 2.4 | 60.9 years STANDARD_DEVIATION 1.6 | 62.5 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
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
In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.
Time frame: 8 weeks
Population: All patient data included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acapella | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Sreening Event | 11.9 g | Standard Deviation 2.8 |
| Acapella | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week1 | 14.4 g | Standard Deviation 3.1 |
| Acapella | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week 2 | 14.5 g | Standard Deviation 3.3 |
| Acapella | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week 4 | 11.8 g | Standard Deviation 2.8 |
| Acapella | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week 6 | 11.7 g | Standard Deviation 2.8 |
| Acapella | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week 8 | 11.6 g | Standard Deviation 2.7 |
| Lung Flute | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week 6 | 12.0 g | Standard Deviation 2.8 |
| Lung Flute | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Sreening Event | 14.5 g | Standard Deviation 3.3 |
| Lung Flute | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week 4 | 15.2 g | Standard Deviation 3.4 |
| Lung Flute | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week1 | 14.3 g | Standard Deviation 3.2 |
| Lung Flute | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week 8 | 12.1 g | Standard Deviation 2.8 |
| Lung Flute | Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | Week 2 | 14.2 g | Standard Deviation 3.2 |
Secondary
Change in CCQ Score
The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.
Time frame: 8 weeks
Population: A patient population included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acapella | Change in CCQ Score | Screening | 2.53 units on a scale | Standard Deviation 0.2 |
| Acapella | Change in CCQ Score | Week 8 | 2.29 units on a scale | Standard Deviation 0.25 |
| Lung Flute | Change in CCQ Score | Screening | 3.24 units on a scale | Standard Deviation 0.3 |
| Lung Flute | Change in CCQ Score | Week 8 | 2.82 units on a scale | Standard Deviation 0.26 |
Secondary
FEV1 - Baseline and Device Comparisons
Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.
Time frame: 8 weeks
Population: A data collected included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acapella | FEV1 - Baseline and Device Comparisons | Week 8 FEV1 | 1.49 liter | Standard Deviation 0.14 |
| Acapella | FEV1 - Baseline and Device Comparisons | Screening FEV1 | 1.43 liter | Standard Deviation 0.13 |
| Lung Flute | FEV1 - Baseline and Device Comparisons | Screening FEV1 | 1.38 liter | Standard Deviation 0.14 |
| Lung Flute | FEV1 - Baseline and Device Comparisons | Week 8 FEV1 | 1.44 liter | Standard Deviation 0.19 |
Secondary
Quality of Life Questionnaire/Daily Diary
St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)
Time frame: 8 weeks
Population: All patient data included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acapella | Quality of Life Questionnaire/Daily Diary | Screening | 45.5 units on a scale | Standard Deviation 3.6 |
| Acapella | Quality of Life Questionnaire/Daily Diary | Week 8 | 45.0 units on a scale | Standard Deviation 4.2 |
| Lung Flute | Quality of Life Questionnaire/Daily Diary | Screening | 51.9 units on a scale | Standard Deviation 3.1 |
| Lung Flute | Quality of Life Questionnaire/Daily Diary | Week 8 | 47.2 units on a scale | Standard Deviation 4.1 |