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

NCT ID: NCT02282202

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-09-30

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.

Detailed Description

Cough and sputum production are common in Bronchiectasis and 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 Positive Expiratory Pressure maneuvers over three weeks in individuals with bronchiectasis and COPD with chronic sputum production. The oPEP device (Aerobika ®) 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 oPEP use will significantly improve dyspnea, movement of mucus, SGRQ score, and 6MWD after three weeks of four times daily administration.

This is a randomized cross-over unblinded study in 30 subjects: ten with bronchiectasis and 20 with COPD (with chronic bronchitis and chronic mucus production identified). Five subjects from the Bronchiectasis group and ten from the COPD group will start with oPEP and use for three weeks. All subjects will crossover at Visit Two after three weeks of oPEP therapy or three weeks of no therapy. Each subject will visit the centre on three occasions: Baseline, Crossover Visit, and Final Visit for approximately one hour each and will perform: 1) spirometry and plethysmography, 2) 6MWT, and 3) health status evaluation using a self-administered 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 (±five minutes) post-salbutamol. Vital signs will be documented and subjects will rest for approximately 15 minutes before 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.

Conditions

Chronic Obstructive Pulmonary Disease; Bronchiectasis

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: OTHER

Oscillating Positive Expiratory Pressure (Aerobika ®)

Intervention Type: 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.

Interventions

Oscillating Positive Expiratory Pressure (Aerobika ®)

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.

Intervention Type: DEVICE

Other Intervention Names

oPEP (Aerobika ®)

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Dr. Grace Parraga

PhD, Scientist. Robarts Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace E Parraga, PhD

Role: PRINCIPAL_INVESTIGATOR

Robarts Research Institute, The University of Western Ontario

David G McCormack, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 589074 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7550205 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3543830 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33289613 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26430763 (View on PubMed)

Other Identifiers

ROB0038

Identifier Type: -

Identifier Source: org_study_id