Boehringer Ingelheim has initiated a pragmatic clinical trial (AIRWISE) in partnership with Anthem and its outcomes research subsidiary HealthCore to investigate the impact of commonly prescribed medicines on exacerbations of chronic obstructive pulmonary disease (COPD).
An exacerbation is defined as sudden worsening of COPD symptoms such as increased breathlessness, cough, mucus production and extreme fatigue, leading to hospitalisation or death.
The primary focus of the randomised, open-label trial is to obtain better insights into the role of long-acting muscarinic antagonists (LAMA), long-acting ß-agonists (LABA) and inhaled corticosteroids (ICS) in decreasing the risk of exacerbations.
During the trial, the effectiveness of Stiolto Respimat Inhalation Spray will be compared with a commercially available LAMA, LABA and ICS combination in a real-life setting in 3,200 adults with COPD.
Stiolto Respimat is a fixed combination of tiotropium bromide (LAMA) and olodaterol (LABA).
The trial will enrol patients who have been determined by a healthcare provider that they are not controlled with their current therapy of LAMA, LABA or ICS / LABA.
Boehringer Ingelheim Pharmaceuticals Primary Care Clinical Development and Medical Affairs vice-president Thomas Seck said: “Due to the significant impact of exacerbations on the health of people with COPD, it is critical that their occurrence is reduced with the safest and most effective treatment plans.
“Our partnership with Anthem and HealthCore is an important initiative to help healthcare providers understand how two treatment approaches work in the real world to reduce the occurrence of exacerbations.”
With results expected to be available in 2020, the AIRWISE trial will assess the time to first moderate or severe COPD exacerbation as its primary endpoint.
Additionally, the trial will compare an annual rate of moderate or severe COPD exacerbations, along with all-cause and COPD-related healthcare resource utilisation such as inpatient admissions, outpatient encounters, emergency room visits and office visits.