{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T09:59:26Z","timestamp":1776851966503,"version":"3.51.2"},"reference-count":17,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,11,24]]},"published-print":{"date-parts":[[2017,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To investigate the efficacy and safety of CS1002, an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based demulcent.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A multicentre, randomised, parallel group, controlled, single-blinded study in participants with acute upper respiratory tract infection-associated cough.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>4 general practitioner (GP) surgeries and 14 pharmacies in the UK.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Participants aged \u226518\u2005years who self-referred to a GP or pharmacist with acute cough of &lt;7\u2005days' duration. Participant inclusion criterion was cough severity \u226560\u2005mm on a 0\u2013100\u2005mm visual analogue scale (VAS). Exclusion criteria included current smokers or history of smoking within the past 12\u2005months (including e-cigarettes). 163 participants were randomised to the study (mean participant age 38\u2005years, 57% females).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Participants were randomised to CS1002 (Unicough) or simple linctus (SL), a widely used cough treatment, and treatment duration was 7\u2005days or until resolution of cough.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>The primary analysis was intention-to-treat (157 participants) and comprised cough severity assessed using a VAS after 3\u2005days' treatment (prespecified primary end point at day 4). Cough frequency, sleep disruption, health status (Leicester Cough Questionnaire (LCQ-acute)) and cough resolution were also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At day 4 (primary end point), the adjusted mean difference (95% CI) in cough severity VAS between CS1002 and SL was \u22125.9\u2005mm (\u221214.4 to 2.7), p=0.18. At the end of the study (day 7) the mean difference in cough severity VAS was \u22124.2\u2005mm (\u221212.2 to 3.9), p=0.31. CS1002 was associated with a greater reduction in cough sleep disruption (mean difference \u221211.6\u2005mm (\u221220.6 to 2.7), p=0.01) and cough frequency (mean difference \u22128.1\u2005mm (\u221216.2 to 0.1), p=0.05) compared with SL. There was greater improvement in LCQ-acute quality of life scores with CS1002 compared with SL: mean difference (95% CI) 1.2 (0.05 to 2.36), p=0.04 after 5 days' treatment. More participants prematurely stopped treatment due to cough improvement in the CS1002 group (24.4%) compared with SL (10.7%; p=0.02). Adverse events (AEs) were comparable between CS1002 (20.5%) and SL (27.6%) and largely related to the study indication. 6 participants (7%) in the CS1002 group reduced the dose of medication due to drowsiness\/tiredness, which subsequently resolved. These events were not reported by participants as AEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Although the primary end point was not achieved, CS1002 was associated with greater reductions in cough frequency, sleep disruption and improved health status compared with SL.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      EudraCT number\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2014-004255-31\/GB\" ext-link-type=\"uri\">2014-004255-31<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2016-014112","type":"journal-article","created":{"date-parts":[[2017,1,16]],"date-time":"2017-01-16T20:38:29Z","timestamp":1484599109000},"page":"e014112","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":21,"title":["Rococo study: a real-world evaluation of an over-the-counter medicine in acute cough (a multicentre, randomised, controlled study)"],"prefix":"10.1136","volume":"7","author":[{"given":"S S","family":"Birring","sequence":"first","affiliation":[{"name":"Division of Asthma, Allergy and Lung Biology, King's College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J","family":"Brew","sequence":"additional","affiliation":[{"name":"Infirst Healthcare Ltd, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A","family":"Kilbourn","sequence":"additional","affiliation":[{"name":"Infirst Healthcare Ltd, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V","family":"Edwards","sequence":"additional","affiliation":[{"name":"Infirst Healthcare Ltd, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R","family":"Wilson","sequence":"additional","affiliation":[{"name":"Spica Consultants Ltd, Marlborough, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A H","family":"Morice","sequence":"additional","affiliation":[{"name":"Hull York Medical School, Castle Hill Hospital, East Yorkshire, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2017,1,16]]},"reference":[{"key":"2025121600422808000_7.1.e014112.1","unstructured":"Proprietary Association of Great Britain (PAGB). 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