Clinical trial NCT02282202: Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD
Official title: Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Bronchiectasis
Keywords: Sputum
Bronchiectasis
Chronic Obstructive Pulmonary Disease
Airway clearance therapy
Oscillatory Positive Expiratory Pressure
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2014-11-04
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in sputum production
timeFrame: weekly for six weeks
Secondary outcomes:
measure: Six Minute Walk Distance (6MWD)
timeFrame: Baseline, 3-weeks (cross-over), 6-weeks
measure: Pulmonary function measurements
timeFrame: Baseline, 3-weeks (cross-over), 6-weeks
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline, 3-weeks (cross-over), 6-weeks
measure: Dyspnea (Patient Evaluation Questionnaire)
timeFrame: Completed weekly for 6 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Robarts Research Institute, The University of Western Ontario
name: Grace E Parraga, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre
name: David G McCormack, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.