THE MICROBIAL EFFECT OF INHALED STEROIDS IN SEVERE COPD PATIENTS WITH ASSOCIATED BRONCHIECTASIS
Research type
Research Study
Full title
THE MICROBIAL EFFECT OF INHALED STEROIDS IN SEVERE COPD PATIENTS WITH ASSOCIATED BRONCHIECTASIS (TEMPESTAS)
IRAS ID
1004221
Contact name
Gourab Choudhury
Contact email
Sponsor organisation
The University of Edinburgh (Lead) & Lothian Health Board (Co-sponsors)
Eudract number
2022-000524-38
ISRCTN Number
ISRCTN15449782
Research summary
A key treatment for patients with advanced Chronic Obstructive Pulmonary Disease (COPD) is to optimise the airways using medicines to open the airways.
In patients with recurrent flare-ups, the addition of inhaled corticosteroids to reduce inflammation in the airways is recommended by national and international guidelines.
Recent published studies raised some concern that inhaled corticosteroids can promote chest infections including pneumonia. However, this is controversial, and the risks are uncertain.
We plan to perform a randomised controlled trial involving a high-risk group of severe COPD patients that have recurrent flare-ups due to bronchiectasis (associated widened and damaged airways) in 80 patients from 3 NHS hospital sites in Scotland. This patient group needs special attention as association of bronchiectasis in COPD can make them more prone to these exacerbations and can increase the mortality rate by up to 20-30%.
We aim to assess whether inhaled steroids along with other type of inhalers that open the airways can affect the amount and type of bacteria in the airways. This is a good patient group to test whether inhaled corticosteroids and other inhalers that open up the airways are safe and will improve patient symptoms and improve the burden of bacteria in lungs or not.
40 patients from each group will receive the dual inhaler ANORO ELLIPTA or the triple inhaler TRELEGY ELLIPTA (which includes the inhaled steroid) to determine the effect of the inhaled steroid over a variety of tests including a sputum test, breathing tests, amongst others. We will follow-up all participants for 12 months.
We also aim to look at the effect of oral corticosteroids on the bacteria in a small number of these patients (five from each treatment group). This would be very interesting and relevant as oral steroids are used for exacerbations in these high-risk patients.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0079
Date of REC Opinion
3 May 2022
REC opinion
Further Information Favourable Opinion