| Trial Acronym | CLEAR |
| Clinical Area | Respiratory |
| Trial Title | 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 | Follow up |
| Trial Registration | http://www.isrctn.com/ISRCTN89040295 |
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Recruitment
Recruitment Target 288 Date Open to Recruitment June 2018 Recruitment 288 Date Closed to Recruitment September 2023 -
Chief Investigator
Chief Investigator: Professor Stuart Elborn s.elborn@qub.ac.uk Lead Applicant Physiotherapist: Professor Judy Bradley Judy.Bradley@qub.ac.uk -
Sponsor & Funder
Sponsors Belfast Health and Social Care Trust Funder National Institute for Health and Care Research Health Technology Assessment
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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 functionThe 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