Bronchiectasis definitions changed to ensure trial quality

An international taskforce of experts has developed new recommendations and definitions for non-cystic fibrosis bronchiectasis to help standardise terminology and boost the quality of patient recruitment in clinical trials.

In a paper published in The Lancet Respiratory Medicine, the authors noted a lack of specific treatments for the condition and the failure of previous randomised controlled trials to meet their endpoints. This, they argued, could partly be because protocols failed to specify radiological or clinical disease criteria for enrolling patients, thus creating heterogeneous study populations.

To help address this, the group prioritised criteria for the radiological diagnosis of bronchiectasis and compiled recommendations on chest CT scans to confirm the presence of the condition for clinical trials. They also developed a set of consensus statements relating to the definitions of clinical bronchiectasis and its signs and symptoms.

The taskforce, which included clinicians from the UK, determined four criteria by which to make a radiological diagnosis of bronchiectasis on chest CT scans: an inner or outer airway-artery diameter ratio of 1.5 or more, a lack of tapering of the airways and visibility of airways in the periphery.

While recognising the wide range of symptoms that can be experienced by patients, the experts concluded that most with clinically significant bronchiectasis “will have at least two of the following: a cough most days of the week; sputum production most days of the week; or a history of exacerbations.”

As no single sign or symptom was considered to be 100% sensitive or specific for bronchiectasis, they proposed that diagnosis of the condition should require at least one recognised diagnostic radiological criteria in combination with one or more of the above clinical symptoms.

Patients with signs of disease on CT but without clinical symptoms “should not be considered to have clinically significant bronchiectasis as a disease, and should not be included in clinical trials of bronchiectasis interventions except as part of natural history studies, possibly testing interventions that could prevent the appearance of signs and symptoms,” according to the paper’s authors.

It is hoped that availability of these recommendations and proposals will help to optimise patient recruitment into clinical trials and enable more relevant and reliable comparisons of treatments for bronchiectasis to improve the likelihood of developing effective new therapies.

“Our consensus proposals should also provide a framework for future research to further refine definitions and establish definitive guidance on the diagnosis of bronchiectasis,” the taskforce noted.

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