A pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, randomised controlled trial, incorporating an internal pilot, to determine the role of bronchodilators in preventing exacerbations of bronchiectasis

ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites600 target enrollmentMay 6, 2020

Overview

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37562935/ (added 14/08/2023)

Registry

who.int

Start Date

May 6, 2020

End Date

July 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ewcastle upon Tyne Hospitals NHS Foundation Trust

•Current inclusion criteria as of 05/09/2022:
•1\. Adult patients with CT\-scan\-confirmed bronchiectasis and bronchiectasis is the predominant primary respiratory disease in the view of the investigator (CT images/CT reports must be available to complete radiological scoring for BSI)
•2\. History of 2 or more exacerbations in any 12\-month period in the preceding 2 years requiring antibiotics and/or steroids
•3\. Evidence of airflow limitation with an FEV1/FVC ratio less than 0\.7 and/or daily mucus expectoration
•4\. Have either:
•4\.1\. Less than 20 pack\-year history of smoking OR
•4\.2\. Greater than 20 pack\-year history of smoking with an FEV1 \>79% predicted (to exclude COPD)
•5\. For patients taking ICS, LAMA or LABA treatment prior to recruitment, willing to have these treatments changed or stopped
•6\. Stable bronchiectasis with no exacerbations for 4 weeks prior to baseline
•7\. Stable dose of oral steroid for 4 weeks prior to baseline (only applicable for patients taking oral steroid as part of standard care)

•Current exclusion criteria as of 05/09/2022:
•1\. Cystic fibrosis\-related bronchiectasis
•2\. Where bronchiectasis is not the main disease or there are contraindications to ICS withdrawal
•3\. Predominant COPD or asthma. (Patients who have a historical diagnosis of asthma and/or COPD but where the investigator has sufficient evidence to refute these diagnoses can still be included. This is to be documented in the source and the CRF.)
•4\. Indication to remain on ICS (e.g. asthma, COPD, allergic bronchopulmonary aspergillosis, inflammatory bowel disease) or known intolerance to any of the trial drugs or their ingredients
•5\. Patients with galactose intolerance, total lactase deficiency or glucose\-galactose malabsorption
•6\. Inability to perform spirometry or quality of life questionnaires
•7\. Patients who are:
•7\.1\. Pregnant
•7\.2\. Breastfeeding