As part of a research collaboration launched in 2014, Boehringer Ingelheim and Anthem have partnered to study people with chronic obstructive pulmonary disease in real-world settings to assess how commonly-prescribed drugs may reduce the occurrence of COPD exacerbations.

The team, which also includes Anthem’s outcomes research subsidiary HealthCore, plans to investigate whether adding an inhaled corticosteroid to a LAMA-LABA combination provides a meaningful benefit – a question under debate in the respiratory space.

A COPD exacerbation is a sudden worsening of symptoms. Patients experiencing a flare-up of the condition may present with symptoms like increased breathlessness, a cough or extreme fatigue.

“Exacerbations of COPD impose a substantial burden on patients and healthcare systems worldwide. They are serious and can lead to accelerated and permanent reductions in lung function, hospitalization or even death, making their prevention very important,” Dr. Thomas Seck, VP of clinical development & medical affairs of Boehringer Ingelheim’s primary care biz, said in an email to Drug Delivery Business News.

“In addition to the detrimental effects on patients’ health, COPD exacerbations may have an impact on healthcare resource utilization due to factors such as hospital admissions, emergency room visits and outpatient visits, and may increase the burden on the healthcare system as a whole.”

The 52-week Airwise trial is slated to enroll 3,200 adults with COPD and compare the effectiveness of Boehringer Ingelheim’s Stiolto Respimat LAMA-LABA combo therapy with any commercially available triple combination of a LAMA, LABA and an inhaled corticosteroid.

The trial’s primary endpoint is the time to first moderate or severe COPD exacerbation. The companies said they expect to have results from the Airwise trial in 2020.

“As a pulmonologist, I am particularly interested in how Airwise will provide real-world data on a broad population of COPD patients that cannot be obtained from traditional randomized clinical trials. This will be invaluable for clinicians and health care organizations alike. Anthem’s national size and depth help to broaden the reach of the trial and will make the evidence more robust,” Anthem’s medical director Dr. Mark Napier said in prepared remarks.

“Moving forward, we hope that Airwise becomes a trailblazer for further pragmatic trials that inform patients, doctors, caregivers, life science companies and those who make health policy decisions,” HealthCore staff VP Vince Willey added.

“We believe it is important that everyday health decisions are based not only on data from traditional clinical trials, but also on data from real-world settings.”

Guidelines from the Global Initiative for Chronic Obstructive Lung Disease suggest that doctors only give an ICS for the most severe cases of COPD, but more than 50% of the time COPD maintenance treatment is initiated with ICS combination therapies, according to Seck.

“A large proportion of healthcare providers presently use ICS -based treatment regimens as a routine part of COPD treatment, indepedent from patients’ severity of their disease. However, emerging clinical evidence suggests that only a small proportion of COPD patients receiving additional benefit from the use of an ICS,” he said.

“Although ICS may be appropriate for some people, ICS combinations are not recommended as first line for patients in any scenario. It is important to understand more about their efficacy to better evaluate their risk-benefit profile.

It is essential that patients are prescribed appropriate treatments and that they are not over-treated with medicines that may provide no additional benefit and involve possible additional side effects.”

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