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

NCT02282189 | Completed

• 1 other identifier: ROB0036
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Sputum; Airway clearance therapy; Oscillatory Positive Expiratory Pressure; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change in Sputum Production

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

  Weekly for eight weeks

Secondary Outcomes (4)

• Six Minute Walk Distance (6MWD)

  Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks

• Pulmonary function measurements

  Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks

• St. George's Respiratory Questionnaire (SGRQ)

  Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks

• Dyspnea (Patient Evaluation Questionnaire)

  Completed weekly for 8 weeks

Study Arms (1)

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

OTHER

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

Device: Oscillating Positive Expiratory Pressure (Aerobika ®)

Interventions

Oscillating Positive Expiratory Pressure (Aerobika ®) DEVICE

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.

Also known as: oPEP

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

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre

London, Ontario, N6A 5B7, Canada

Location

Related Publications (1)

• 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.

  PMID: 26430763 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grace E Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

• David G McCormack, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Scientist. Robarts Research Institute

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: November 4, 2014
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

CA (1)