Researchers seeking volunteers for Australian study of new treatment for devastating lung disease

Australian researchers are recruiting volunteers aged 40+ living with severe emphysema to study a new two-stage procedure for the devastating lung disease by October 2022.

COVE is an Australian study investigating the safety and effectiveness of a first-in-human procedure for those living with severe emphysema who have ‘collateral ventilation’ – air flow between lobes of the lung which bypasses the normal airways.

Currently, Australians living with severe emphysema with collateral ventilation face limited treatment options due to the structure of their lungs. Therefore, many continue to experience disabling symptoms and major disruptions to their daily lives. With collateral ventilation occurring in 62 per cent of those living with severe emphysema, the COVE Study hopes to expand treatment options for this patient group.

According to a just-published article in Medical Journal of Australia’s (MJAs) InSight+, authored by COVE Study Lead Investigator, and Consultant Thoracic Surgeon at St Vincent’s Hospital Melbourne and East Melbourne Heart and Lung, Dr Naveed Alam, Melbourne, exploring new treatments are critical to improving the lives of those with emphysema.

“Without proper management and treatment, emphysema can cause difficulties breathing and talking, a blue tinge to the skin due to lack of oxygen, regular chest infections, and may even cause heart failure.

“These symptoms can affect a patient’s physical and emotional wellbeing, with up to one in three Australians living with emphysema reporting some level of disability due to the lung disease,” said Dr Alam.

“Moreover, those affected are four times more likely to experience very high levels of psychological distress than those without emphysema, with breathlessness, or the fear of breathlessness, commonly causing anxiety and depression.

“Given the limited treatment options currently available to people with severe emphysema, particularly those with collateral ventilation, we hope to address this unmet need by investigating a novel treatment option through the COVE Study,” Dr Alam said.

The researchers aim to recruit more than 20 Australians living with severe emphysema into the COVE Study by October 31, 2022.

“If you’re aged 40 years or over, and have been diagnosed with severe, or very severe emphysema, ask your GP or specialist whether you qualify for the COVE Study,” said COVE Study Co-Investigator, Director of Surgical Oncology, and Consultant Thoracic Surgeon, St Vincent’s Hospital Melbourne, and East Melbourne Heart and Lung, A/Prof Gavin Wright, Melbourne.

The disease develops gradually and is among Australia’s leading causes of death. With emphysema, the air sacs of the lungs become damaged and destroyed, causing the lungs to lose their natural elasticity.

As severe emphysema advances and symptoms worsen, those affected may find daily activities, such as standard exercise, hanging out the washing, food shopping, getting out of bed, and even sleeping, increasingly difficult.

Wife, grandmother-to-seven and COVE Study participant Cecilia, Melbourne, was diagnosed with emphysema almost 30 years ago.

“Living with severe emphysema is physically and mentally debilitating,” she said. “Not being able to breathe is terrifying. There have been times when I’ve been so afraid of being breathless that I have been too scared to move. It’s also demoralising being unable to look after myself,” Cecilia said.

Cecilia has chosen to participate in emphysema clinical studies to help inform additional treatment options for the disease.

“Nothing in life is guaranteed. But participating in a clinical study may help me and others living with this devastating disease,” said Cecilia.

Although there is currently no cure for emphysema, effective treatment and management may slow the disease down and extend the number of years a person is expected to live and manage symptoms to help improve their quality of life.

“One of the most significant advances in treating severe emphysema over the past two decades has been the development of endobronchial valves (EBVs),”A/Prof Wright said. EBVs help prevents the lung from overinflating – a common symptom of severe emphysema – while allowing trapped air to escape.19 Treatment with EBVs is most effective in patients who do not have collateral
ventilation.

“Collateral ventilation occurs when the wall-like physical dividers (or fissures) between lobes of the lung are not solid, allowing air to pass through one lobe to another.

“The use of EBVs in severe emphysema patients with little to no collateral ventilation has been shown to improve lung function, reduce shortness of breath, and increase their ability to exercise and participate in everyday activities,” said A/Prof Wright.

“Unfortunately, with collateral ventilation occurring in 62 per cent of those living with severe emphysema, this represents a significant portion of Australians with the disease who are currently unable to access EBV treatment.”

To help address this unmet need, the COVE Study will examine the safety and effectiveness of combining the following two medical procedures four weeks apart:

• Video Assisted Thoracic Surgery (VATS) fissure completion – A surgical procedure to completely close off the fissure structure in the affected lung, blocking airflow between different lobes.
• Insertion of endobronchial valves (EBVs) – a minimally invasive procedure involving the insertion of small, one-way EBVs into the most diseased part of the lung where the fissure was completed.
• Six months after EBV insertion, the study researchers will measure each participant’s lung function, lung volume, tolerance to exercise, shortness of breath, and Quality of Life (QoL) scores.

“If combining these two procedures is shown to be both safe and effective, it might eventually become an option for some people with emphysema who have previously not been suitable for surgery,” A/Prof Wright said.

St Vincent’s Hospital Melbourne and St Vincent’s Private Hospital Melbourne are now recruiting for the COVE Study. Study participants are required to travel to one of these Melbourne locations. Patients living with severe emphysema located outside Victoria can ask their GP to refer them to one of the select hospitals in Brisbane, Sydney, Launceston and Adelaide to help determine if they may participate in the COVE Study.

To learn more or to register your interest in the COVE Study, head to covestudy.com.au or email info@covestudy.com.au.