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

Trial Summary

What is the purpose of this trial?

The goal of this non-pharmacologic interventional study is to learn if Oscillatory Positive Expiratory Pressure (OPEP) therapy can improve disease impact and respiratory system dynamics in patients with COPD. The main questions it aims to answer are: Is OPEP therapy able to improve the impact of cough symptoms as measured on a validated symptom score? Is OPEP therapy able to improve the properties of the lung (called reactance) as measured by oscillometry? Researchers will compare the results of the same tests performed before and after 4 weeks of OPEP treatment to see if OPEP treatment improves cough symptoms and lung mechanics. * Participants with COPD will complete in-person baseline tests and will then receive the smart OPEP device. * These participants will then use the smart OPEP device at home, at least twice a day, for 4 consecutive weeks. * Finally, these participants will return to complete in-person end-of-study tests.

Research Team

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

Principal Investigator

RI-MUHC/MUHC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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