Here you can read summaries of scientific articles relating to the NOVELTY study, re-written for the general public.
Information about asthma/COPD research. Full article available here.
This article aimed to assess the strengths and weaknesses of ‘observational studies’ in asthma and/or chronic obstructive pulmonary disease (COPD); including emphysema and chronic bronchitis. An ‘observational study’ is a type of study in which researchers collect health information from patients who continue their usual treatment regimen. The patients do not have to take any new or different medicines. Assessing the strengths and weaknesses of these studies will help us to improve the design of future research into asthma and COPD.
A clinical trial is a research study testing how effective possible treatments are. They are useful for finding out if a new treatment is safe and effective. However, these trials are very strict about whom they include. This means that as little as 5% of people with asthma and/or COPD would qualify for most clinical trials. This is because clinical trials try to compare people who are very similar to one another to make it easier to measure the effectiveness of the treatment. For example, a clinical trial might only include non-smokers who have very poor lung function. As a result, treatments are approved after testing in people with specific types of asthma and/or COPD. Observational studies are one way in which treatments can be tested in other people who also need these treatments; patients who would not typically be included in clinical trials.
Observational studies have contributed to important findings about asthma and COPD. For example, the findings that obesity or low fruit and vitamin C intake can increase the risk of asthma. Observational studies have also found that people with asthma or COPD who use multiple inhalers with different techniques have more flare-ups than people who use inhalers that are similar. Studies like these can give us a detailed picture of the many things that can affect people with asthma and/or COPD outside of tightly controlled clinical trials.
One of the main benefits of this type of study is that a wide range of people can be included. This means that findings of observational studies are more applicable to people with different ‘types’ of asthma and/or COPD than clinical trials. Studying a range of patients tells us more about how different people might respond. This can help us to better understand the different types of asthma and/or COPD. A greater understanding of asthma and COPD will also help us to move towards a more personalised approach to treatment. In other words, the most effective treatments can be given to patients depending on the type of asthma and/or COPD they have, making treatments more adapted to the individual patient.
One of the challenges of observational studies is that there may be differences between the patients, such as how long they have had their asthma and/or COPD, their eating habits or the amount of exercise they do. These differences influence the results but are not measured in the study. This makes it more challenging to know whether a treatment was effective, as the findings could be due to something that was not measured.
Both observational studies and clinical trials are needed to form a complete picture of the best treatments due to their different strengths and weaknesses. However, more observational studies are required. The NOVELTY study is an example of an observational study – you can read more about NOVELTY here. The NOVELTY study aims to understand the many different disease characteristics or traits that determine the different types of asthma and/or COPD. This will help us to move towards more personalised treatments.
Information about asthma/COPD research. Full article available here.
Asthma and chronic obstructive pulmonary disease (COPD) are long-term conditions that affect the lungs. You can read more about asthma and COPD here.
Many people with severe asthma or severe COPD are not able to take part in most research studies testing the effectiveness of potential treatments (known as clinical trials). This is because clinical trials usually aim to study a particular group of people with the most ‘typical’ or characteristic features of the disease. For example, people who have features of both asthma and COPD are often excluded from clinical trials. Having features of both asthma and COPD is especially common in people with severe asthma and severe COPD. However, not including people like this in clinical trials means that less is known about how to treat them. This is important because the results of clinical trials help to create guidelines for doctors to use when deciding on treatments for their patients.
People with asthma and people with COPD can experience similar symptoms. For example, although wheezing is generally seen in asthma and phlegm is more common in COPD, shortness of breath and coughing occur in both conditions. Likewise, people who find that inhaled medications help to open their airways are typically diagnosed with asthma, even though some people with COPD find these helpful too. These similarities might be due to similar types of damage inside the airways.
Doctors decide how to treat people by their symptoms and their response to medications, rather than by the damage inside their airways. A new approach to grouping patients based on the changes inside their airways may encourage researchers to design studies differently. This means future clinical trials might be less specific about who they include, and people with a broader range of symptoms and disease features may be able to take part. This would allow people with more complex forms of the disease to be studied in more detail. Results from these studies might lead to updated treatment guidelines, which would help doctors to find the best treatments for individual patients.
A more personalised approach to treatment would mean that people could find a treatment that works for them more quickly and easily. The NOVELTY study is an important stepping stone to change the way researchers and doctors think about severe asthma and severe COPD.
NOVELTY study design. Full article available here.
Asthma and chronic obstructive pulmonary disease (COPD; including emphysema and chronic bronchitis) are long-term conditions affecting the lungs. Asthma and COPD are often considered separate diseases, although they share some symptoms; some types of asthma have similar underlying causes to some types of COPD. Most research studies choose patients with either asthma or COPD, and exclude patients with both diagnoses (sometimes called asthma–COPD overlap). This means our current understanding of what causes these lung conditions, and how they relate to each other, is poor. NOVELTY is a study of around 12,000 patients with a diagnosis of asthma, COPD or both diagnoses, from 19 countries across North and South America, Europe and Asia. Most patients with any of these conditions are eligible for NOVELTY. The study aims to follow patients for 3 years, to better understand:
Asthma and COPD are amongst the most studied chronic diseases but progress in finding new, more effective treatments has been slow and disappointing. NOVELTY is a very large, global and innovative study that goes beyond the scope of similar, previous studies to change the way people think about these diseases. It is enhanced by the wide range of patients from diverse settings, and by the fact that many different types of information are being collected over time. NOVELTY will provide a unique source of data that can be used to understand the similarities and differences between patients with asthma, patients with COPD and patients with both conditions. The study aims to identify new underlying causes of these diseases to enable treatments that are driven by biology, rather than by the broad diagnoses currently used. A greater understanding may result in more personalised healthcare, with treatments that are better tailored to each patient based on their specific type of disease.