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Effectiveness of antitussives, anticholinergics or honey versus usual care in adults with uncomplicated acute bronchitis: a study protocol of an open randomised clinical trial in primary care
  1. Josep M Cots1,
  2. Ana Moragas2,
  3. Ana García-Sangenís3,4,
  4. Rosa Morros3,5,
  5. Ainhoa Gomez-Lumbreras3,
  6. Dan Ouchi6,
  7. Ramon Monfà6,
  8. Helena Pera3,4,
  9. Jesus Pujol7,
  10. Carolina Bayona8,
  11. Mariam de la Poza-Abad9,
  12. Carl Llor10
  1. 1 Primary Healthcare Centre La Marina, Barcelona, Spain, Universitat de Barcelona, Barcelona, Catalunya, Spain
  2. 2 Primary Healthcare Centre Jaume I, Universitat Rovira i Virgili, Tarragona, Catalonia
  3. 3 Medicines Research Unit, Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Catalonia
  4. 4 UICEC IDIAP Jordi Gol, Plataforma SCReN, Barcelona, Catalonia
  5. 5 Departament de Farmacologia i Terapèutica, Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Barcelona, Catalonia
  6. 6 Institut Universitari d’Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, Catalonia
  7. 7 Balaguer Health Centre, Balaguer, Catalonia
  8. 8 Primary Healthcare Centre La Marina, Barcelona, Catalonia
  9. 9 Institut Català de la Salut, Barcelona, Catalonia
  10. 10 Primary Healthcare Centre Barcelona-2B (via Roma), Barcelona, Catalonia
  1. Correspondence to Dr Carl Llor; carles.llor{at}gmail.com

Abstract

Introduction Despite the frequent use of therapies in acute bronchitis, the evidence of their benefit is lacking, since only a few clinical trials have been published, with low sample sizes, poor methodological quality and mainly in children. The objective of this study is to compare the effectiveness of three symptomatic therapies (dextromethorphan, ipratropium or honey) associated with usual care and the usual care in adults with acute bronchitis.

Methods and analysis This will be a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than 3 weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, dextromethorphan 30 mg three times a day, ipratropium bromide inhaler 20 µg two puffs three times a day or honey 30 mg (a spoonful) three times a day, all taken for up to 14 days. The exclusion criteria will be pneumonia, criteria for hospital admission, pregnancy or lactation, concomitant pulmonary disease, associated significant comorbidity, allergy, intolerance or contraindication to any of the study drugs or admitted to a long-term residence. Sample: 668 patients. The primary outcome will be the number of days with moderate-to-severe cough. All patients will be given a paper-based symptom diary to be self-administered. A second visit will be scheduled at day 2 or 3 for assessing evolution, with two more visits at days 15 and 29 for clinical assessment, evaluation of adverse effects, re-attendance and complications. Patients still with symptoms at day 29 will be called 6 weeks after the baseline visit.

Ethics and dissemination The study has been approved by the Ethical Board of IDIAP Jordi Gol (reference number: AC18/002). The findings of this trial will be disseminated through research conferences and peer-review journals.

Trial registration number NCT03738917; Pre-results.

  • infectious diseases
  • therapeutics
  • respiratory infections

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors JMC, AGS, RM and CL drafted the research protocol and both AGS and CL wrote the manuscript. AM, AGS, RM, HP, AGL and CL were involved in the protocol development. JMC, AM, JP, CB, MPA and CL will be involved in trial conduct and recruitment. DO contributed to the statistical design and analysis. All authors have contributed to the conception of this clinical trial.

  • Funding The AB4T study received a research grant from the Carlos III Institute of Health (ISCIII), Ministry of Economy and Competitiveness (Spain), awarded on the 2017 call under the Health Strategy Action 2013-2016, within the National Research Program oriented to Societal Challenges, within the Technical, Scientific and Innovation Research National Plan 2013-2016, with reference PI17/01345, co-funded with European Union ERDF funds (European Regional Development Fund). This study is also supported by the Spanish Clinical Research Network (SCReN), funded by ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, project number PT17/0017/0005, within the National Research Program I+D+I 2013-2016 and co-funded with European Union ERDF funds (European Regional Development Fund).

  • Competing interests AM and CL report receiving research grants from Abbott Diagnostics.

  • Ethics approval Ethical Board of IDIAP Jordi Gol (reference number: AC18/002).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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