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 adults with bronchiectasis: a protocol for the CLEAR clinical trial

Trials

On behalf of the CLEAR study group¹  Jamie Duckers²  Brenda O’Neill³  Adam T. Hill⁴  Alistair McGuire⁵  Michael R. Loebinger⁶  Anthony De Soyza⁷  Kathryn Ferguson⁸  Naomi Dickson⁹  Christina Campbell⁹  Ashley Agus⁹  Fionnuala McKinney⁹  Roisin Boyle⁹  Evie Gardner⁹  Mike Clarke^1,10  Fiona Copeland^1,11  James Chalmers^1,12  Mary Carroll^1,13  Danny F. McAuley^1,14  Rohan Anand^1,14  Judy Martina Bradley^1,14  Stuart Elborn^1,14 

[1] ;Cardiff and Vale University Health Board, University Hospital Llandough;Centre for Health and Rehabilitation Technologies (CHaRT), Institute of Nursing and Health Research, Ulster University;Centre for Inflammation Research, University of Edinburgh;Department of Health Policy, London School of Economics and Political Science;Faculty of Medicine, National Heart and Lung Institute, Imperial College and Royal Brompton Hospital;NIHR Biomedical research centre (BRC) for Aging, Institute of Cellular Medicine, Newcastle University;Northern Ireland Clinical Research Network, Belfast Health and Social Care Trust;Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust;Northern Ireland Methodology Hub, Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast;PCD Family Support Group, Ciliopathy Alliance;School of Medicine, University of Dundee;Southampton University Hospitals NHS Trust;Wellcome-Wolfson Institute For Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast;

关键词: Clinical trial protocol;    Factorial design;    Bronchiectasis;    Hypertonic saline;    Carbocisteine;    Exacerbation;   

DOI  :  10.1186/s13063-019-3766-9

来源: DOAJ

【 摘 要 】

Abstract Background Current guidelines for the management of bronchiectasis (BE) highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum removal as part of standard care. We hypothesise that mucoactive agents (HTS or carbocisteine, or a combination) are effective in reducing exacerbations over a 52-week period, compared to usual care. Methods This is a 52-week, 2 × 2 factorial, randomized, open-label trial to determine the clinical effectiveness and cost effectiveness of HTS 6% and carbocisteine for airway clearance versus usual care - the Clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care (CLEAR) trial. Patients will be randomised to (1) standard care and twice-daily nebulised HTS (6%), (2) standard care and carbocisteine (750 mg three times per day until visit 3, reducing to 750 mg twice per day), (3) standard care and combination of twice-daily nebulised HTS and carbocisteine, or (4) standard care. The primary outcome is the mean number of exacerbations over 52 weeks. Key inclusion criteria are as follows: adults with a diagnosis of BE on computed tomography, BE as the primary respiratory diagnosis, and two or more pulmonary exacerbations in the last year requiring antibiotics and production of daily sputum. Discussion This trial’s pragmatic research design avoids the significant costs associated with double-blind trials whilst optimising rigour in other areas of trial delivery. The CLEAR trial will provide evidence as to whether HTS, carbocisteine or both are effective and cost effective for patients with BE. Trial registration EudraCT number: 2017-000664-14 (first entered in the database on 20 October 2017). ISRCTN.com, ISRCTN89040295. Registered on 6 July/2018. Funder: National Institute for Health Research, Health Technology Assessment Programme (15/100/01). Sponsor: Belfast Health and Social Care Trust. Ethics Reference Number: 17/NE/0339. Protocol version: v3.0 Final_14052018.

【 授权许可】

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