Microbiome Use to evaluate Safety of Inhaled Corticosteroids: MUSIC
Research type
Research Study
Full title
Investigating the mechanism of inhaled corticosteroids associated pneumonia by longitudinal characterisation of the airway microbiome in patients with severe COPD
IRAS ID
202267
Contact name
James Chalmers
Contact email
Sponsor organisation
University of Dundee
Eudract number
2016-000734-21
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Research Summary
The MUSIC TRIAL is a randomized controlled trial to test the hypothesis that inhaled therapies for Severe Chronic Obstructive Pulmonary Disease (COPD), particularly the inhaled corticosteroids budesonide and fluticasone propionate, have differential effects on the upper airway microbiome (lung bacteria). Patients with COPD are frequently prescribed inhalers which contain steroids to help prevent symptoms getting worse. In recent years it has become clear that some patients respond better to steroids than others. Given to the right patients, inhaled steroids can help prevent a worsening of symptoms and improve quality of life. In other patients, they are less effective and may also increase the risk of getting pneumonia.
This is a multi-centre randomised open label controlled study with four treatment arms and a total planned evaluable cohort of 120 participants. COPD patients currently treated with inhaled corticosteroid therapy (ICS) will be randomised to treatment with one of three preparations of ICS in combination with long acting beta2-adrenoceptor agonists (LABA) or the control arm of dual bronchodilator therapy following a four week washout period. Participants will return monthly for tests to determine if there are changes in the microbiome in their upper airway.
This study will establish one potential mechanism for the increased susceptibility to pneumonia in ICS users and assess intraclass differences in ICS molecules used in COPD and the effect of ICS dose on the microbiome. It is known that changes in the microbiome in COPD are associated with disease severity and with lung inflammation. Demonstrating that different COPD treatments can have different effects on the lung microbiome is an important step in understanding clinical differences in the safety and effectiveness of different treatments for severe COPD.
Summary of Results
Chronic obstructive pulmonary disease (COPD) is a long-term lung condition that causes breathlessness and cough. There are several treatments available for COPD including anti-inflammatory inhalers containing a steroid and inhalers which help to open up the airways (bronchodilators) that don’t contain a steroid. Patients with COPD are frequently prescribed inhalers which contain steroids to help prevent symptoms getting worse. In recent years it has become clear that some patients respond better to steroids than others. Given to the right patients, inhaled steroids can help prevent a worsening of symptoms and improve quality of life. In other patients, they are less effective and may also increase the risk of getting pneumonia. Finding out why some patients benefit and why some are harmed by treatment is important.
The inhaled corticosteroids budesonide and fluticasone propionate, have differential effects on the upper airway microbiome (lung bacteria). We perform a trial in 61 people with COPD; 13 patients received Seretide Accuhaler 500, 15 patients received Seretide accuhaler 250, 18 patients received Symbicort turbohaler 400 and 15 patients received Duaklir. We found no change in the total amount of bacteria in the lungs however, overtime we did find that those taking Fluticasone/salmeterol 500 had more bacteria in their lungs than those taking budesonide/formoterol. These results will be helpful for identifying which patients at risk of chest infections with different steroid preparations.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0096
Date of REC Opinion
26 Aug 2016
REC opinion
Further Information Favourable Opinion