Condition category
Respiratory
Date applied
22/06/2015
Date assigned
06/07/2015
Last edited
15/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.respironics.com

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

Publication citations

Additional files

Editorial Notes

13/10/2016: Internal review