- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282189
Longitudinal Study of Oscillatory Positive Expiratory Pressure (oPEP) in Stable COPD
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5B7
- Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Off/on for 4 weeks followed by on/off for 4 weeks
Subjects are randomized to either Oscillating Positive Expiratory Pressure device or no device for four weeks, then crossover for the following four weeks.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sputum Production
Time Frame: Weekly for eight weeks
|
Change in sputum production from subject self-reported questionnaires performed weekly
|
Weekly for eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six Minute Walk Distance (6MWD)
Time Frame: Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks
|
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
|
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)
|
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
|
Baseline, 2-weeks, 4-weeks (cross-over), 6-weeks, 8-weeks
|
|
Dyspnea (Patient Evaluation Questionnaire)
Time Frame: Completed weekly for 8 weeks
|
Completed weekly for 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David G McCormack, MD, London Health Sciences Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROB0036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Oscillating Positive Expiratory Pressure (Aerobika ®)
-
Western University, CanadaLondon Health Sciences CentreCompletedBronchiectasis | Chronic Obstructive Pulmonary DiseaseCanada
-
Instituto Nacional de Cancerologia de MexicoActive, not recruitingLung Cancer | Mediastinal Tumor | Pleural TumorMexico
-
FLUIDDA nvCompletedPulmonary Disease, Chronic Obstructive | COPDBelgium
-
Western University, CanadaNot yet recruitingSurgery | Surgery--Complications | Pulmonary Complication
-
Poudre Valley Health SystemMonaghan Medical CorporationRecruitingRespiratory Complication | Rib FracturesUnited States
-
Lawson Health Research InstituteUnknownCardiac Surgery | Chronic Obstructive Pulmonary Disease (COPD) | Older Adults | Coronary Artery Bypass Grafting | Postoperative Pulmonary ComplicationsCanada
-
Hill-RomUnknownBronchiectasis | Bronchiectasis With Acute ExacerbationUnited States
-
University of Mississippi Medical CenterRecruitingObesity | Respiratory FailureUnited States
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Gachon University Gil Medical CenterCompletedCerebral IschemiaKorea, Republic of