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-September 2022
Target Recruitment	288
Recruitment to date	284 as of 04/09/2023
No. of Sites	18

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