Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD

• ClinicalTrials.gov Identifier: NCT02282189
• Recruitment Status: Completed
• First Posted: November 4, 2014
• Last Update Posted: June 27, 2018
• Sponsor: Western University, Canada
• Collaborator: London Health Sciences Centre
• Information provided by (Responsible Party): Dr. Grace Parraga, Western University, Canada

Tracking Information

• First Submitted Date: October 24, 2014
• First Posted Date: November 4, 2014
• Last Update Posted Date: June 27, 2018
• Study Start Date: July 2012
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2014)

Change in Sputum Production [ Time Frame: Weekly for eight weeks ]

Change in sputum production from subject self-reported questionnaires performed weekly

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 9, 2014)

• Six Minute Walk Distance (6MWD) [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]
• Pulmonary function measurements [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]
  Pulmonary function measurements include FEV1 (Forced expiratory volume in 1 second); FVC (forced vital capacity); FEV1/FVC ratio; TLC (total lung capacity); RV (residual volume); DLCO (Diffusing capacity of the lung)
• St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]
• Dyspnea (Patient Evaluation Questionnaire) [ Time Frame: Completed weekly for 8 weeks ]

Original Secondary Outcome Measures (submitted: October 30, 2014)

• Six Minute Walk Distance (6MWD) [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]
• Pulmonary function measurements [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]
• St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks ]
• Dyspnea (Patient Evaluation Questionnaire) [ Time Frame: Completed weekly for 8 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
• Official Title: Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
• Brief Summary: The purpose of this study is to evaluate the safety and efficacy of four times daily oscillatory Positive Expiratory Pressure (oPEP) (Aerobika ®) use over 4 weeks in individuals with stable chronic obstructive pulmonary disease (COPD). The investigators hypothesize that daily oPEP use will significantly improve St. George's Respiratory Questionnaire (SGRQ) score, six-minute walk distance (6MWD) and forced expiratory volume in one second (FEV1) after four weeks of four times daily administration.

Detailed Description

Cough and sputum production is common in chronic obstructive pulmonary disease (COPD), both of which are associated with significant morbidity and other adverse clinical outcomes. Airway clearance techniques (ACTs) such as afforded by oscillatory Positive Expiratory Pressure (oPEP) (Aerobika ®) aim to remove sputum from the lungs, however evidence of their efficacy during stable disease is unclear.

The objective of this study is to evaluate the safety and efficacy of four times daily oPEP use over 4 weeks in individuals with stable COPD. The oPEP device combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. oPEP therapy enforces a resistance to exhalation at the mouth while the airway vibration technology transmits movements upstream during exhalation so that airway walls may become free from mucus. An adjustable dial allows users to adjust the frequency and the flow resistance based on their individual needs. Subjects will take a device home and use four times daily during the active part of the study. We hypothesize that daily (Aerobika ®) use will significantly improve St. George's Respiratory Questionnaire (SGRQ) score, six-minute walk distance (6MWD) and forced expiratory volume in one second (FEV1) after four weeks of four times daily administration.

This is a randomized cross-over unblinded study in 15 subjects with COPD. All subjects will cross-over at four weeks of oPEP therapy or four weeks of no therapy. Each subject will visit the centre on five occasions (baseline, 2 weeks, 4 weeks (cross-over), 6 weeks and 8 weeks) for one hour each and will perform: 1) spirometry and plethysmography, 2) six-minute walk test (6MWT), and 3) health status evaluation using a self-administered St. George's Respiratory Questionnaire (SGRQ). Subjects will first provide written informed consent and will complete: 1) SGRQ after inhaling 2-4 puffs (200-400µg) of the short-acting bronchodilator (eg. Salbutamol), 2) plethysmography and spirometry 35±5 minutes post-salbutamol. Vital signs will be documented and subjects will rest for approximately 15 minutes before completing the six-minute walk test (6MWT) post-salbutamol. Subjects will be given an oPEP therapy system (Aerobika ®) to use at home, four times per day. Instruction and training on the use of the device will be given at the baseline visit. Subjects will be required to return the device upon completion of the study.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease

Intervention

Device: Oscillating Positive Expiratory Pressure (Aerobika ®)

The oPEP system combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. oPEP therapy enforces a resistance to exhalation at the mouth, while the airway vibration technology transmits movements upstream during exhalation so that airway walls may become free from mucous. Subjects will take home the device and use four times daily during the active part of the study.

Other Name: oPEP

Study Arms

Off/on for 4 weeks followed by on/off for 4 weeks

Subjects are randomized to either Oscillating Positive Expiratory Pressure device or no device for four weeks, then crossover for the following four weeks.

Intervention: Device: Oscillating Positive Expiratory Pressure (Aerobika ®)

• Publications *: Svenningsen S, Paulin GA, Sheikh K, Guo F, Hasany A, Kirby M, Rezai RE, McCormack DG, Parraga G. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74. doi: 10.3109/15412555.2015.1043523. Epub 2015 Oct 2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 30, 2014): 17
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects male and female aged 40-85 with a clinical diagnosis of chronic obstructive pulmonary disease (COPD)
• Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
• Subject is judged to be in otherwise stable health on the basis of medical history
• Subject is ambulatory and can perform the 6MWT
• Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater).
• FEV1 >25% predicted
• FVC > 25% predicted and >0.5L

Exclusion Criteria:

• Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material. Capacity to consent will be determined by either Dr. McCormack at the time of the clinic visit or Sandra Blamires, the study coordinator.
• Patient is unable to perform spirometry or plethysmography maneuvers
• Patient is pregnant

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02282189
• Other Study ID Numbers: ROB0036
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Grace Parraga, Western University, Canada
• Study Sponsor: Western University, Canada
• Collaborators: London Health Sciences Centre

Investigators

• Principal Investigator: Grace E Parraga, PhD; Robarts Research Institute, The University of Western Ontario
• Principal Investigator: David G McCormack, MD; London Health Sciences Centre

• PRS Account: Western University, Canada
• Verification Date: June 2018