Boehringer Ingelheim announced a new post-hoc sub-analysis of the WISDOM study. It suggests that only 4 in 100 people of the study population – with a history of frequent exacerbations and raised eosinophil levels (=400 cells/µL) – may benefit by adding ICS to Spiriva Handihaler (tiotropium bromide inhalation powder) and a long-acting beta2-agonist (salmeterol) to further reduce the risk of exacerbations.

Eosinophils, which are a type of white blood cell, are assessed as part of a routine blood test. This new sub-analysis was presented at the European Respiratory Society (ERS) International Congress 2016 in London.

"New results from the WISDOM study indicate that using ICS as part of a triple therapy regimen in COPD maintenance treatment reduces the likelihood of an exacerbation for a smaller number of people than previously thought. It challenges our current understanding of the appropriate use of ICS in COPD maintenance therapy," said study investigator Professor Peter Calverley, Professor of Pulmonary and Rehabilitation Medicine, University of Liverpool, UK. "These study results add important information to a debate that has potentially wide-ranging implications for the future treatment of people with COPD."

Exacerbations significantly contribute to the impact of COPD, often leading to hospitalizations and contributing to the risk of death. The Global Initiative for Chronic Obstructive Lung Disease (GOLD), which is a collaboration between the World Health Organization and the US National Institutes of Health, recommends the use of ICS-containing treatment only in people with COPD who have severe to very severe lung function impairment and/or are at high risk of exacerbations or who have had a hospitalization (GOLD C/D) – the patient population studied in WISDOM. However, ICS treatments are widely used outside of GOLD treatment recommendations in combination with bronchodilators, such as tiotropium and salmeterol, in the treatment of COPD.

This new sub-analysis suggests that by combining a patient history of frequent exacerbations (two or more exacerbations in the past twelve months) with raised blood eosinophil levels of =400 cells/µL, healthcare providers may more precisely identify the minority of people with COPD who could benefit from the addition of ICS on top of tiotropium and salmeterol for further exacerbation risk reduction.

This finding builds on an earlier sub-analysis of the WISDOM trial that evaluated blood eosinophil levels alone and indicated that people with blood eosinophil levels higher than =300 cells/µL benefitted from the addition of ICS on top of tiotropium and salmeterol in reducing the risk of an exacerbation.

The 52-week WISDOM study (NCT00975195) evaluated the effect of ICS withdrawal in people with severe to very severe COPD having a history of exacerbation, while receiving tiotropium and salmeterol. The patient population of the WISDOM trial represents approximately 20 percent of the normal COPD patient population and only 4 percent of this study population was known to have a history of frequent exacerbations (two or more exacerbations in the past twelve months) with raised blood eosinophil levels of =400 cells/µL.

"Boehringer Ingelheim is committed to continuing scientific research that informs the optimal treatment of people with COPD. These findings add to our understanding of the factors that should be considered by healthcare providers when deciding a treatment regimen for people with COPD – specifically when to add an ICS," said Dr. William Mezzanotte, vice president and head, respiratory medicine at Boehringer Ingelheim. "In addition, these findings highlight the importance of further investigation and discussion of this topic."

In the WISDOM study population, complete ICS withdrawal was associated with a small reduction in trough FEV1. A prior post-hoc analysis showed overall no relationship between blood eosinophil count and change in lung function with ICS withdrawal. However, the latest post-hoc analysis indicated a relevant reduction in trough FEV1 in the small subgroup of people with high eosinophil count and frequent exacerbations.

Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The most common symptom of COPD is shortness of breath, especially with physical activities. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.

Spiriva Handihaler (tiotropium bromide inhalation powder) is a prescription medicine used once each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis, emphysema, or both. Spiriva Handihaler also reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations).