CLEAR Trial

Trial Acronym CLEAR
Clinical Area Respiratory
Description A 2×2 factorial randomised open label trial to determine the clinical and cost- effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care over 52 weeks in bronchiectasis
Status Open to recruitment
RECRUITMENT
Recruitment Duration June 2018-August 2020 (dependant on internal pilot)
Target Recruitment 380
Recruitment to date 143 as of 2nd February 2020
No. of Sites 16
TRIAL DESIGN
Trial Design A multicentre 2×2 factorial randomised open label trial in bronchiectasis with a 12-month follow-up period.
Study Aim To deliver a UK multicentre study that will determine the clinical and cost -effectiveness of hypertonic saline HTS (6%) and carbocisteine for airway clearance versus usual care over 52 weeks in bronchiectasis using a 2×2 factorial randomised open label trial design.
The primary objective is to determine whether HTS (6%) and/or carbocisteine reduce the mean number of exacerbations over 52 weeks post randomisation.
Secondary Objectives

To determine whether HTS and/or carbocisteine:
i. Improve disease specific HRQoL at 52 weeks
ii. Reduce time to next exacerbation
iii. Reduce number of days of antibiotics for exacerbations over 52 weeks
iv. Improve generic HRQoL
v. Are acceptable from a patient satisfaction perspective at 52 weeks
vi. Are associated with AEs
vii. Improve lung function

The study will also assess:
viii. The cost-effectiveness of the four treatment options
ix. Patient adherence to HTS and carbocisteine over 52 weeks and how this impacts on the overall results

CHIEF INVESTIGATOR (CI)
Chief Investigator Professor Stuart Elborn
SPONSOR(s) & FUNDER(s)
Sponsors Belfast Health and Social Care Trust
Funder NIHR
Links http://www.isrctn.com/ISRCTN89040295
Twitter – TrialCLEAR