Oscillatory Positive Expiratory Pressure Therapy for COPD

Overseen By Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Bronchiectasis, Cystic fibrosis, Recent exacerbation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a device called Oscillatory Positive Expiratory Pressure (OPEP) can assist people with COPD, a lung disease that makes breathing difficult, by easing cough symptoms and improving lung function. Participants will use the device at home twice daily for four weeks. The trial focuses on individuals diagnosed with COPD who have a history of smoking and experience regular sputum production or a productive cough. Tests conducted before and after using the device will reveal any improvements. As an unphased trial, this study allows participants to contribute to valuable research that could enhance COPD management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a device for therapy, so it's best to ask the study team for guidance.

What prior data suggests that Oscillatory Positive Expiratory Pressure therapy is safe for COPD patients?

Research has shown that Oscillatory Positive Expiratory Pressure (OPEP) therapy is safe for people with COPD. In one study, participants reported no side effects, even after two weeks of follow-up, indicating the therapy is generally well-tolerated. Another study found that using OPEP therapy four times a day was effective and did not raise any safety concerns. Additionally, patients using OPEP therapy have experienced better breathing and improved lung function. These findings suggest that OPEP therapy is a safe option for managing COPD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Oscillatory Positive Expiratory Pressure (OPEP) therapy is unique because it uses a smart device to help clear mucus from the airways, which can be particularly beneficial for people with COPD. Unlike traditional inhalers or nebulizers, which deliver medication to open airways, OPEP therapy involves breathing out against resistance to create vibrations that loosen mucus and make it easier to expel. Researchers are excited about this treatment because it offers a non-drug approach that patients can use at home, potentially improving their breathing and quality of life without the side effects associated with medication.

What evidence suggests that Oscillatory Positive Expiratory Pressure therapy is effective for COPD?

Research has shown that Oscillatory Positive Expiratory Pressure (OPEP) therapy can benefit people with COPD. Studies have found that regular use of OPEP devices, such as the Acapella or Aerobika, improves symptoms and quality of life for those who cough up mucus daily. One study found that OPEP therapy significantly reduces shortness of breath. Additionally, these devices help clear mucus from the lungs more easily. Overall, incorporating OPEP therapy into a treatment plan can effectively manage COPD symptoms. Participants in this trial will use the smart OPEP device at least twice a day at home for four consecutive weeks. ^{1 2 3 6 7}

Who Is on the Research Team?

Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)

Principal Investigator

RI-MUHC/MUHC

Are You a Good Fit for This Trial?

This trial is for adults over 40 who smoke or used to smoke a lot, have COPD confirmed by lung function tests, and often cough up phlegm. They must be able to do breathing tests without extra oxygen and agree to participate.

Inclusion Criteria

I am 40 years old or older.

Ability to provide informed consent

I have smoked for 10 or more years.

Exclusion Criteria

My main lung condition is not chronic lung disease like bronchiectasis or cystic fibrosis.

I have not been diagnosed with COPD.

I was diagnosed with a lung problem or hospitalized for it in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants complete in-person baseline tests and receive the smart OPEP device

1 week

1 visit (in-person)

Treatment

Participants use the smart OPEP device at home, at least twice a day, for 4 consecutive weeks

4 weeks

End-of-Study Assessment

Participants return to complete in-person end-of-study tests

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oscillatory Positive Expiratory Pressure (OPEP) Therapy

Trial Overview Researchers are testing if OPEP therapy can lessen the impact of coughing and improve lung function in COPD patients. Participants will use an OPEP device at home twice daily for four weeks, with before-and-after tests to measure changes.

How Is the Trial Designed?

Group I: Oscillatory Positive Expiratory Pressure (OPEP) therapy arm Experimental Treatment 1 Intervention

Participants will receive and use the smart OPEP device at least twice a day in the home environment for 4 consecutive weeks.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Trudell Medical International

Collaborator

Trials

4

Recruited

330+

Trudell Medical International

Industry Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35948418/

Oscillatory positive expiratory pressure therapy in COPD (O ... Regular use of an Acapella device improves symptoms and quality of life in people with COPD who produce sputum daily or most days.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9623861/

Therapeutic efficacy of oscillating positive expiratory ... The present study showed a beneficial effect of OPEP in the management of COPD patients. The results suggest incorporation of OPEP device as an add-on ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02282202

Evaluation of Oscillatory Positive Expiratory Pressure ... The purpose of this study is to evaluate the safety and efficacy of four times daily Positive Expiratory Pressure (oPEP) (Aerobika ®) maneuvers over three ...

4. tandfonline.com tandfonline.com/doi/full/10.3109/15412555.2015.1043523

Oscillatory Positive Expiratory Pressure in Chronic ... The objective of this crossover study was to evaluate daily use of an oscillatory positive expiratory pressure (oPEP) device for 21–28 days in COPD patients.

5. journal.chestnet.org journal.chestnet.org/article/S0012-3692(16)43376-3/fulltext

Oscillatory Positive Expiratory Pressure (oPEP) Treatment in ... For all subjects, dyspnea was significantly reduced after oPEP therapy (p=0.03). For six subjects with improved VDP, the ease in bringing up ...

6. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-021-01689-y

An initial evaluation of the safety of a disposable oscillating ... The results indicate that the UL-OPEP is safe to use in patients with COPD. No adverse events were recorded during the study or in the follow-up period of 2 ...

7. tandfonline.com tandfonline.com/doi/full/10.2147/COPD.S256866

Impact of Oscillating Positive Expiratory Pressure Device ... Oscillating positive expiratory pressure (OPEP) devices have been shown to improve clinical outcomes when added to COPD standard of care.