Chronic Obstructive Pulmonary Disease (COPD) and asthma are two lung diseases that may be on the same spectrum. COPD has two main disease facets; emphysema and bronchitis. Emphysema is the loss of elasticity of the alveoli, air sacs, of the lungs that results in air becoming trapped and making it difficult to breath. Bronchitis is inflammation of the lungs which results in excessive mucus secretion, resulting in a phlegm cough. Asthma is a long-term inflammatory lung disease causing airway restriction and brochospasms or “asthma attacks”.
There is no cure for either condition and current clinical trials only capture between 2 and 10% of the total patient population, usually patients with the most severe disease. This creates an opportunity for real-world evidence (RWE) to supplement clinical trials and gain a more holistic representation of the whole patient population.
Leif Bjermer from Lund University, Sweden, and colleagues recently described the BREATHE research platform in the European Clinical Respiratory Journal. The platform aims to develop a detailed, comprehensive database and biobank with real-world clinical data and samples from patients with different severities of lung disease as well as a reference population of healthy controls. Real-world data is less structured than that generated by a clinical trial enabling participation without undue patient burden, however such data is inherently less statistically powerful. Such a strategy can, however, represent the majority of the patient population, which has never been achieved before.
The two year study of 1,492 people, recruited COPD, asthma and healthy participants from Denmark and Sweden. In addition to universal baseline measurements some patients received a bronchoscopy. Participants underwent and interview, physical examination, routine baseline measurements, 12 questionnaires were filled, exhaled nitric oxide levels were recorded, spirometry lung function test was performed, static lung volume was taken, Mannitol bronchial provocation hyperresponsiveness test was performed, allergy testing and skin prick testing was performed.
The following samples were taken:
- Nasal swabs
- Leukocyte and differential cell counts
- Bronchoscopy subset donated in addition;
- bronchoalveolar lavage (BAL)-fluid
- brushings and mucosa biopsies
“The current study represents, to our knowledge, the largest clinical real-life study on patients with obstructive airway diseases: asthma, COPD, or concurrent asthma and COPD with different degrees of severity and phenotypes. With this study, we have generated a research platform with a unique database and biobank from 1492 well-characterized subjects including patients from both specialized centres and from primary care centres. Patients were recruited from both capital cities and more rural areas, and include obese and non-obese, smokers and non-smokers, as well as control subjects consisting of healthy controls, healthy smokers and patients referred with asthma or COPD symptoms but where the diagnosis cannot be confirmed, many of which are unique features of our study,” concluded the authors.