Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name used to refer to a number of progressive devastating and debilitating lung diseases, which includes chronic bronchitis, emphysema and chronic obstructive airways disease. People that have COPD typically feel breathless after physical activity, have a persistent cough with phlegm and suffer frequently from chest infections. Feeling short of breath can lead to inactivity and muscle deconditioning in patients with COPD. Positive airway pressure (PAP) can relieve shortness of breath and improve exercise tolerance (the amount of exercise that they are able to do). This study examines the effect of PAP delivered by a battery powered handheld device to COPD patients after exercise to relieve shortness of breath.
Who can participate?
Aged at least 18 with diagnosed COPD but able to do mild exercise.
What does the study involve?
Participants are randomly allocated into one of three groups. They are all then asked to do some mild exercise. Those in group 1 are then provided with the portable PAP device to use after the exercise to ease breathlessness. Those in group 2 are provided with what looks like a portable PAP device, but it is nonfunctional (a SHAM device) to use after the exercise. Those in group 3 are asked to perform lip breathing after exercise. The time it takes to return to the shortness of breath experienced prior to exercise for each participant is determined. We anticipate that the time after exercise to return to baseline shortness of breath using the hand held device is shorter than that while using a SHAM device and pursed-lip breathing (PLB) after exercise. As a secondary outcome, we will evaluate the distance walked during exercise.
What are the possible benefits and risks of participating?
Other than possibly gaining a better understanding of their ability to exercise and contributing to general knowledge of strategies to address shortness of breath, participants will not benefit directly from enrolling in the study. Risks of study participation include breathing and general discomfort while exercising. Lung damage from the portable positive airway pressure device is a remote possibility. Participants will be closely monitored during exercise and may request that the exercise activity be terminated. Patients with a history of lung damage from positive pressure devices are not eligible to participate.
Where is the study run from?
Pittsburgh Pulmonary Associates Ltd (USA)
When is the study starting and how long is it expected to run for?
April 2014 to October 2015
Who is funding the study?
Philips Respironics (USA)
Who is the main contact?
Mr William Hardy
bill.hardy@philips.com
Trial website
Contact information
Type
Public
Primary contact
Mr William Hardy
ORCID ID
Contact details
Philips Respironics
1740 Golden Mile Highway
Monroeville
PA 15146
United States of America
+ 724 387 4169
bill.hardy@philips.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HRC-1510-ENGVB-SS
Study information
Scientific title
Effect of intermittent positive air pressure in relieve of shortness of breath in COPD patients after exertion.
Acronym
Study hypothesis
To determine whether intermittent positive airway pressure given after exercise to patients with COPD can shorten their shortness of breath recovery period
Ethics approval
Allendale Institutional Review Board (AIRB), 26/03/2015
Study design
Prospective, interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Chronic obstructive pulmonary disease
Intervention
Participants are asked to undergo exercise session and then use one of the following to alleviate shortness of breath:
1. Portable battery powered positive airway pressure (PAP) device
2. Portable sham positive airway pressure device
3. Pursed lip breathing
Intervention type
Device
Phase
Drug names
Primary outcome measures
Time to return to baseline shortness of breath rating after exercise
Secondary outcome measures
Distance walked during exercise
Overall trial start date
06/04/2014
Overall trial end date
30/10/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age ≥ 18
2. Ability to provide consent
3. COPD diagnosis with FEV1 < 55 and > 25 of predicted value
4. Perceived Shortness of Breath via the Modified Medical Research Counsel Dyspnea questionnaire (rating of 2 or greater)
5. Able to follow directions
6. Able to tolerate mild physical activity
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Subjects who are acutely ill, medically complicated or who are medically unstable as determined by the investigator
2. Suffering from COPD Exacerbation at time of data collection
Recruitment start date
06/04/2015
Recruitment end date
30/10/2015
Locations
Countries of recruitment
United States of America
Trial participating centre
Pittsburgh Pulmonary Associates, Ltd
-
United States of America
Sponsor information
Organisation
Philips Respironics
Sponsor details
1740 Golden Mile Highway
Monroeville
15146
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Philips Respironics (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submitted late breaking abstract to the 2015 European Respiratory Society meeting. Upon completing recruitment of approximatlely thirty (30) participants, a peer reviewed publication is anticipated.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary