Shortness of breath bothered Julia Sheppard every day. She had no energy and had to use a motorized cart to do her shopping. (Chris Clark | Spectrum Health Beat)
Gustavo Cumbo-Nacheli, MD, chose Julia to become the first participant from western Michigan in a new clinical trial for patients with severe chronic obstructive pulmonary disease, or COPD. (Chris Clark | Spectrum Health Beat)
Spectrum Health is one of about two dozen clinical sites in the United States selected to participate in the Airflow-3 trial, sponsored by Nuvaira Inc. (Chris Clark | Spectrum Health Beat)
A special probe uses high frequency energy to deactivate the nerves in the lungs. These overactive nerves can cause the air ducts to narrow and collapse, making it difficult for patients to breathe. (Chris Clark | Spectrum Health Beat)
“Over time, since the nerves do not disrupt the bronchi, we expect to see fewer and fewer flare-ups of emphysema,” said Dr. Cumbo-Nacheli. (Chris Clark | Spectrum Health Beat)
“Does this procedure have an impact not only on quality of life, but also on life expectancy? This is exactly what we are studying,” said Dr Cumbo-Nacheli. He predicts that the answer will be yes. (Chris Clark | Spectrum Health Beat)
Once the multi-year Airflow-3 study is complete, the U.S. Food and Drug Administration may evaluate the results and decide to make it widely available. (Chris Clark | Spectrum Health Beat)
Maximiliano Tamae Kakazu, MD, right, a pulmonologist working with Dr. Cumbo-Nacheli, will follow up with trial participants for a year or more after the procedure to track their progress. (Chris Clark | Spectrum Health Beat)
Julia’s doctors in Kalamazoo referred her to Spectrum Health for evaluation because she had “reached maximum medical treatment,” Dr Cumbo-Nacheli said. (Chris Clark | Spectrum Health Beat)
“Usually I’ve had more bad days than good days,” Julia said. “Now I have more good days than bad days. I feel a hundred percent better.” (Chris Clark | Spectrum Health Beat)
“My breathing is much better,” said Julia. “Sometimes I even forget to use my inhaler – because I’m supposed to do morning treatments and evening treatments.” (Chris Clark | Spectrum Health Beat)
Since returning to Kalamazoo, Michigan, from Las Vegas two years ago to be closer to her children and grandchildren, Julia Sheppard, 61, has used a motorized cart to do her shopping.
His sick lungs made walking the aisles too difficult.
Shortness of breath bothered her every day, draining her energy and limiting her activities.
But in January 2021, for the first time in recent memory, Sheppard was running errands.
“I just went to the store – and usually I get in a stroller – but I went to the store and pushed a cart through the store,” she says.
“I can get around a lot better, and it’s not even been a month yet.”
In fact, it had only been three weeks – to the day – since Sheppard had undergone an innovative new lung procedure at Spectrum Health Butterworth Hospital.
Three weeks since becoming the first West Michigan participant in a new clinical trial for patients with chronic obstructive pulmonary disease, or COPD, a generic term for conditions such as emphysema.
The research trial involves a one-hour outpatient procedure that uses radiofrequency ablation – targeted high-frequency energy – to damage nerves in the lungs’ two main airways. These hypersensitive nerves can trigger constriction of the airways and mucus production, making it difficult for patients to breathe.
By turning off the nerves in the airways, the study aims to prevent exacerbations of COPD – sudden flare-ups that can increase the risk of infection, get patients to hospital, and create additional lung damage.
Spectrum Health is one of less than two dozen clinical sites in the United States selected to participate in the Airflow-3 test, sponsored by Nuvaira Inc.
The testing procedure uses a thin, flexible scope, fed through the patient’s mouth and to the lungs, in tandem with a specialized catheter that delivers radiofrequency energy.
“It’s a very precise probe that is placed in a very specific position in the air ducts, or the bronchi… in order to damage the nerves that cause the air ducts to narrow and collapse,” said Gustavo Cumbo-Nacheli, MD, spectrum health interventional pulmonologist who worked with those responsible for the system’s institutional research to gain approval for the Airflow-3 trial at Butterworth Hospital.
“Over time, since the nerves do not disrupt the bronchi, we expect to see fewer and fewer flare-ups of emphysema, allowing patients to be symptom-free.”
The first test phases, Airflow-1 and Airflow-2, took place mainly in Europe and gave promising results, said Dr Cumbo-Nacheli.
The US-based phase aims to determine whether this procedure, by reducing the number of COPD flare-ups, can safely provide short- and long-term benefits.
“Does this procedure have an impact not only on quality of life, but also on life expectancy? This is exactly what we are studying, ”said Dr. Cumbo-Nacheli, who is the only Spectrum Health vendor trained to perform the testing procedure.
He predicts the answer will be yes because, he said, “relapses are the single most important factor affecting the life expectancy” of COPD patients.
The impact of this disease is large and costly, said Dr Cumbo-Nacheli.
Once the multi-year Airflow-3 study is complete, the U.S. Food and Drug Administration may evaluate the results and decide to make it widely available.
Doctors have high hopes for this trial because they have so few options for treating COPD patients, according to Maximiliano Tamae Kakazu, MD, a Spectrum Health pulmonologist who is partnering with Dr. Cumbo-Nacheli in screening patients for admission to the Airflow-3 trial.
Dr. Tamae Kakazu follows up with trial participants for a year or more after the procedure to track their progress.
“We are limited with the interventions we can do to try to improve the quality of life,” said Dr. Tamae Kakazu.
“We offer these interventions to all of our patients – inhalers, vaccination, smoking cessation counseling and, for those who are eligible, pulmonary rehabilitation and other therapies – but we hope to find another intervention that can improve the lives of patients with the disease. of COPD.
Sheppard’s doctors in Kalamazoo referred her to Spectrum Health for evaluation for the same reason – she had “reached maximum medical treatment,” Dr Cumbo-Nacheli said.
Despite the use of daily medications and physical therapy, Sheppard still struggles with regular outbreaks of COPD.
“I would fight to breathe,” she said. “I would be in the hospital two to three times a year. A hospital stay is usually two to three days (but) when you have a relapse it can last about a week or two. “
This has been her role model for the past six years, Sheppard said. She was diagnosed with COPD eight years ago.
Recognizing Spectrum Health’s leadership in interventional pulmonology, specialists at Sheppard hoped she would qualify for a clinical trial.
After meeting Drs. Cumbo-Nacheli and Tamae Kakazu – and learning that she met all the criteria for the essay – she signed up without hesitation.
Within two weeks of her first consultation, Sheppard returned to Butterworth Hospital as the first patient in the West Michigan Airflow-3 trial.
The pulmonary denervation process, performed under sedation, went “perfectly”, said Dr Cumbo-Nacheli.
Although doctors have warned she likely won’t feel positive effects from the procedure for 30 days, Sheppard said she could tell the difference in a matter of weeks.
Her breathing calmed down and her energy jumped.
“I move around a lot better,” she says. “My breathing is much better. Sometimes I even forget to use my inhaler – because I’m supposed to do morning treatments and evening treatments.
“Usually I’ve had more bad days than good days. Now I have more good days than bad days. I feel a hundred percent better.
As one of the first patients to enroll in the trial, Sheppard knew ahead of time that she would receive the denervation treatment.
After the first two participants, however, all registrants enter the bronchoscopy room knowing they have a fifty-fifty chance of receiving a dummy version of the procedure.
Study administrators randomly assign half of the patients to receive the ablation treatment and the other half to receive sham treatment, “which means they undergo the procedure, but no energy is supplied,” so there is no cut to the nerve, ”said Dr. Cumbo-Nacheli.
Only Dr. Cumbo-Nacheli learns which patient receives which version of the procedure. By staying in the dark, Dr. Tamae Kakazu can perform his periodic follow-ups of his patients without bias or assumptions.
One year after the date of the procedure, patients can find out whether or not they have received the ablation. Those who have received the sham procedure then have the option of returning for the actual treatment.
Dr Cumbo-Nacheli plans to recruit 15 to 20 patients in the first year. The application criteria are as follows:
- Between 40 and 78 years old
- Take medication daily to manage COPD
- Not a current or future smoker
- Have had at least one COPD flare in the past year
With the first positive signs, Sheppard hopes to see continued improvement in his health.
“It seems like every day I feel better and better,” she said. “And I hope it gets a lot better so I can go out and do more things… like going for a walk and spending time with my grandchildren and doing things like that.”
Sheppard, who started smoking at 19 and smoked a pack a day for the next 34 years, is grateful for the chance to share her story with others who may qualify for the trial.
“The way I feel now, I want people to know it’s something good,” Sheppard said.
“I am so happy and blessed that they chose me and chose me to do this.”