by Harry Rossiter PhD
Despite the obvious impact of COVID-19 on the progression of new research developments in COPD, there’s plenty to look forward to in 2021.
Here I highlight two bronchoscopy-based treatments for chronic bronchitis or COPD that are currently underway in the US:
- The Gala Airway Treatment System RheOx clinical trial is a phase 2 trial (the phase to test whether a treatment is safe and works as expected, in a small study of targeted individuals) investigating a device for the treatment of chronic bronchitis. The treatment is delivered during bronchoscopy with the patient under general anesthesia, in 2 sessions of treatment 1 month apart. This system delivers a short burst of high-frequency electric energy to the lining of the airways, targeting abnormal, mucus-producing cells. The system aims to promote the airway lining to regenerate fewer mucus-producing cells, therefore resulting in reductions in mucus, cough, airway obstruction, and shortness-of-breath. [ClinicalTrails.gov registration number NCT03631472].
- The AIRFLOW 3 clinical trial is a phase 3 trial (the final phase of research to test whether a treatment is safe works in a wide population, prior to regulatory approval for clinical use) investigating a procedure for the treatment of COPD, called Targeted Lung Denervation (TLD). The goal of TLD treatment is to disconnect many of the airway nerves at the point where they enter the lungs. The treatment is delivered during bronchoscopy with the patient under general anesthesia. Because COPD flare-ups are, in part, driven by over-active airway nerves in the lungs that cause mucus and airway tightening, in a previous trial of 82 COPD patients this treatment was successful in reducing the number and severity of COPD flare-ups. Most patients are able to return home the same day of the procedure. This study is still recruiting participants; using this link you can find out whether there is a study center near you. [NCT03639051].
Another study’s approach posits that a good nights’ sleep is a primary pillar of good health (others being nutrition and exercise). A hypnotic drug designed to promote sleep with minimal negative effects on next-day functioning is being trialed in moderate COPD patients in Germany. The study employs a dual orexin receptor blocker. Nighttime respiratory function, oxygen levels, and total sleep time will be measured. [NCT03646864].
Readers of this blog will know that pulmonary rehabilitation is the most effective treatment to reduce shortness-of-breath in COPD. Indeed, PERF Chairman, Professor Richard Casaburi was recently awarded the President’s Medal from the European Respiratory Society for his vital role in improving the scientific basis of pulmonary rehabilitation for COPD patients. COVID-19 has devastated the uptake and access for COPD patients to pulmonary rehabilitation. Therefore, it is not surprising that there are many studies underway to investigate the effectiveness of delivering pulmonary rehabilitation using virtual, or telehealth, approaches in people’s homes. Programs that deliver virtual pulmonary rehabilitation without sacrificing increases in muscle strength and endurance are likely to be the most successful. If you would like to join a trial of home-based exercise therapy for COPD patients, here is a list of some of the trials currently registered and enrolling in North America:
- Zuckerberg San Francisco General Hospital: NCT03287440
- Mayo Clinic (Florida and Minnesota): NCT03480386
- University of Kansas Medical Center: NCT03489642
- VA Boston Healthcare System: NCT03794921
- Carolinas Health Care System: NCT03801330
- Mount Sinai Hospital New York: NCT03981783
- VA Pittsburg Healthcare System: NCT03997513
- Québec Institute of Cardiology and Pulmonology: NCT04658979
- VA Medical Center Houston: NCT04306588
Adjuncts to pulmonary rehabilitation, such as muscle building drugs (anabolic), have been the focus of COPD research for many years. A new class of anabolic drugs called SARMs (selective androgen receptor modulators) is an oral pill that is designed to promote the growth of muscle and bone, without the negative side effects of anabolic steroids. A new phase 2 study in 98 male and female COPD patients will report in 2021. Data on ClinicalTrials.gov shows significant increases in lean body mass and leg strength with SARM treatment and combined home exercise, compared with home exercise alone. [NCT03359473].
PERF is proud that several PERF board members and their colleagues at the Lundquist Institute in Torrance, CA are involved in many of these clinical studies, which aim to improve the lives of patients with COPD.
Combined with COVID-19 vaccine trials, there is much for COPD patients to look forward to in 2021!