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Trial Outcomes & Findings for Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (NCT NCT00181207)

NCT ID: NCT00181207

Last Updated: 2018-10-19

Results Overview

count of exacerbations per group per 12 weeks. An exacerbation was defined based on three major symptoms: increasing dyspnea, increasing sputum purulence and increasing sputum volume. Exacerbations were counted if there were at least 2 of these 3 symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-10-19

Participant Flow

Participant milestones

Participant milestones
Measure
Sham
Placebo Comparator: Sham Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating
Active
Experimental: Active Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks
Overall Study
STARTED
24
26
Overall Study
COMPLETED
24
26
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sham
n=24 Participants
received sham version of VEST
Active
n=26 Participants
received functional version of VEST
Total
n=50 Participants
Total of all reporting groups
Age, Continuous
62.8 years
STANDARD_DEVIATION 9.0 • n=5 Participants
62.5 years
STANDARD_DEVIATION 7.4 • n=7 Participants
62.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
10 Participants
n=7 Participants
18 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
16 Participants
n=7 Participants
32 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=5 Participants
2 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
White
17 Participants
n=5 Participants
23 Participants
n=7 Participants
40 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
24 Participants
n=5 Participants
26 Participants
n=7 Participants
50 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

count of exacerbations per group per 12 weeks. An exacerbation was defined based on three major symptoms: increasing dyspnea, increasing sputum purulence and increasing sputum volume. Exacerbations were counted if there were at least 2 of these 3 symptoms.

Outcome measures

Outcome measures
Measure
Sham
n=24 Participants
received sham version of VEST
Active
n=26 Participants
received functional version of VEST
The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.
5.5 exacerbations per 12 weeks
Interval 3.0 to 8.0
4 exacerbations per 12 weeks
Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

The SF-36 is used to measure health related quality of life. It assesses eight health concepts and provides physical and mental health summary scores. The summary scores range from 0 to 100, with 0 representing the worst and 100 the best quality of life.

Outcome measures

Outcome measures
Measure
Sham
n=24 Participants
received sham version of VEST
Active
n=26 Participants
received functional version of VEST
Quality of Life
5 units on a scale
Interval -5.0 to 10.0
0 units on a scale
Interval -12.5 to 5.0

Adverse Events

Sham

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gregory Diette

Johns Hopkins University

Phone: 410-955-3497

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place