Chronic Obstructive Pulmonary DiseaseNCT02282189
Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
A study testing Oscillating Positive Expiratory Pressure (Aerobika ®) in people with Chronic Obstructive Pulmonary Disease, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Oscillating Positive Expiratory Pressure (Aerobika ®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, N6A 5B7
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Oscillating Positive Expiratory Pressure (Aerobika ®)
- Keywords
- Sputum, Airway clearance therapy, Oscillatory Positive Expiratory Pressure, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillating Positive Expiratory Pressure (Aerobika ®)Device
Also called oPEP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oscillating Positive Expiratory Pressure (Aerobika ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sputum Production
Change in sputum production from subject self-reported questionnaires performed weekly
Measured: Weekly for eight weeks
Secondary outcomes (4)
Six Minute Walk Distance (6MWD)
Measured: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks
Pulmonary function measurements
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)
Measured: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks
St. George's Respiratory Questionnaire (SGRQ)
Measured: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks
Dyspnea (Patient Evaluation Questionnaire)
Measured: Completed weekly for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Principal investigator, Dr. Grace Parraga, Western University, Canada
- Investigators
- Grace E Parraga, PhD, Principal investigator, Robarts Research Institute, The University of Western OntarioDavid G McCormack, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282189
- Sponsor's protocol ID
- ROB0036
- Status last verified
- Jun 2018
- First submitted
- 24 Oct 2014
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26430763
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
- ClinicalTrials.gov ID
- NCT02282189
- Acronym / sponsor ID
- ROB0036
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Sputum, Airway clearance therapy, Oscillatory Positive Expiratory Pressure, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Off/on for 4 weeks followed by on/off for 4 weeks | Other | Device: Oscillating Positive Expiratory Pressure (Aerobika ®)Subjects are randomized to either Oscillating Positive Expiratory Pressure device or no device for four weeks, then crossover for the following four weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oscillating Positive Expiratory Pressure (Aerobika ®)Also: oPEPThe 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. | Device | Off/on for 4 weeks followed by on/off for 4 weeks |
Primary outcome
Change in Sputum Production
Time frame: Weekly for eight weeks
Change in sputum production from subject self-reported questionnaires performed weekly
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Derived from this study: PubMed 26430763Svenningsen 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.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace E Parraga, PhD principal investigator
Robarts Research Institute, The University of Western Ontario
David G McCormack, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oscillating Positive Expiratory Pressure (Aerobika ®) in people with Chronic Obstructive Pulmonary Disease, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sputum Production (time frame: Weekly for eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02282189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.