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 Duration | June 2018-September 2022 |
Target Recruitment | 288 |
Recruitment to date | 284 as of 04/09/2023 |
No. of Sites | 18 |
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: The study will also assess: |
Chief Investigator | Professor Stuart Elborn |
Sponsors | Belfast Health and Social Care Trust |
Funder | NIHR |
Links | http://www.isrctn.com/ISRCTN89040295 Twitter – TrialCLEAR |