INCOGNITO trial- Investigating COPD lung infections with two inhalers
Research type
Research Study
Full title
INvestigating COPD Outcomes, Genomics and Neutrophilic Inflammation with Tiotropium and Olodaterol (INCOGNITO trial)
IRAS ID
219751
Contact name
James Chalmers
Contact email
Sponsor organisation
University of Dundee
Eudract number
2016-004473-41
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Research Summary
The INCOGNITO trial is a randomized controlled trial to test the hypothesis that combined treatment with two bronchodilators in a single inhaler (Tiotropium and oladaterol- SPIOLTO) will improve immune system function and therefore reduce the amount of lung bacteria in patients with COPD previously treated with inhaled corticosteroids, when compared with ongoing treatment with inhaled corticosteroids in the form of fluticasone furoate and vilaterol- RELVAR).
Given to the right patients inhaled corticosteroids can be beneficial in COPD. Some patients with COPD, however, develop chest infections, including pneumonia when treated with inhaled corticosteroids. Corticosteroids can prevent cells in the lung called neutrophils from killing bacteria leading to infections. We believe that patients with inflammation caused by neutrophils will therefore respond better to a treatment with tiotropium and oladaterol that does not contain steroids.
This is a multi-centre randomised open label controlled study with two treatment arms and a total planned enrolment of 80 participants. COPD patients currently treated with inhaled corticosteroid therapy (ICS) will be randomised to treatment with either Spiolto or Relvar. Patients will then return at 1, 2, 3 and 6 months after treatment to look for infection in the lungs and look at immune cell function.The study will help to understanding "personalised medicine" in COPD by seeing if the bacteria and immune cells in the lungs in patients with "neutrophilic type COPD" respond better to tiotropium and vilaterol rather than Relvar.
Summary of Results
Chronic obstructive pulmonary disease (COPD) is a long term lung condition that causes breathlessness and cough. There are a number of treatments available for COPD including anti-inflammatory inhalers containing a steroid and inhaled let help to open up the airways (bronchodilators) that don’t contain a steroid. Steroids may reduce the frequency of symptoms and chest infections, but can also cause an increase in infections in certain people. Finding out why some patients benefit and some are harmed by treatment is important. We perform a trial in 80 people with COPD, half of whom received a steroid inhaler and half who received a bronchodilator inhaler. We measured infection using molecular tests in sputum samples and other samples to look at how the different treatments changed the bacteria in the lungs (called the microbiome). We found no change in the total amount of bacteria in the lungs but a change in the types of bacteria with steroids. In this patient group, not taking a steroid appeared to be associated with a lower risk of infections. These results will be helpful for identifying which patients will benefit most from steroids and bronchodilators in the future.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0148
Date of REC Opinion
9 Feb 2017
REC opinion
Further Information Favourable Opinion