Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD

NCT02282202 | Completed

• 1 other identifier: ROB0038
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of four times daily Positive Expiratory Pressure (oPEP) (Aerobika ®) maneuvers over three weeks in individuals with bronchiectasis and chronic obstructive pulmonary disease (COPD) with chronic sputum production. The investigators hypothesize that four times daily positive expiratory pressure using the Aerobika ® will significantly improve dyspnea, movement of mucus, St. George's Respiratory Questionnaire (SGRQ) score, and six-minute walk distance (6MWD) after three weeks of four times daily administration.

Conditions

Chronic Obstructive Pulmonary Disease; Bronchiectasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in sputum production

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

  weekly for six weeks

Secondary Outcomes (4)

• Six Minute Walk Distance (6MWD)

  Baseline, 3-weeks (cross-over), 6-weeks

• Pulmonary function measurements

  Baseline, 3-weeks (cross-over), 6-weeks

• St. George's Respiratory Questionnaire (SGRQ)

  Baseline, 3-weeks (cross-over), 6-weeks

• Dyspnea (Patient Evaluation Questionnaire)

  Completed weekly for 6 weeks

Study Arms (1)

Off/on for 3 weeks followed by on/off for 3 weeks

OTHER

Subjects are randomized to either Oscillating Positive Expiratory Pressure device (Aerobika ®) or no device for three weeks, then crossover for the following three weeks.

Device: Oscillating Positive Expiratory Pressure (Aerobika ®)

Interventions

Oscillating Positive Expiratory Pressure (Aerobika ®) DEVICE

The oPEP system (Aerobika ®) combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. oPEP therapy (Aerobika ®) 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. There is only one intervention for this study. Subjects are "on" treatment for three weeks and "off" for the alternate three weeks.

Also known as: oPEP (Aerobika ®)

Off/on for 3 weeks followed by on/off for 3 weeks

Eligibility Criteria

• Age: 40 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 either a clinical diagnosis of bronchiectasis or COPD with chronic bronchitis and chronic mucous production identified
• 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 (5)

• Cochrane GM, Webber BA, Clarke SW. Effects of sputum on pulmonary function. Br Med J. 1977 Nov 5;2(6096):1181-3. doi: 10.1136/bmj.2.6096.1181.

  PMID: 589074 BACKGROUND

• Ambrosino N, Callegari G, Galloni C, Brega S, Pinna G. Clinical evaluation of oscillating positive expiratory pressure for enhancing expectoration in diseases other than cystic fibrosis. Monaldi Arch Chest Dis. 1995 Aug;50(4):269-75.

  PMID: 7550205 BACKGROUND

• Oberwaldner B, Evans JC, Zach MS. Forced expirations against a variable resistance: a new chest physiotherapy method in cystic fibrosis. Pediatr Pulmonol. 1986 Nov-Dec;2(6):358-67. doi: 10.1002/ppul.1950020608.

  PMID: 3543830 BACKGROUND

• Capaldi DPI, Guo F, Xing L, Parraga G. Pulmonary Ventilation Maps Generated with Free-breathing Proton MRI and a Deep Convolutional Neural Network. Radiology. 2021 Feb;298(2):427-438. doi: 10.1148/radiol.2020202861. Epub 2020 Dec 8.

  PMID: 33289613 DERIVED

• 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; Bronchiectasis

Condition Hierarchy (Ancestors)

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

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: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

CA (1)