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BMJ Open. 2017 Jan 16;7(1):e014112. doi: 10.1136/bmjopen-2016-014112.

Rococo study: a real-world evaluation of an over-the-counter medicine in acute cough (a multicentre, randomised, controlled study).

Author information

1
Division of Asthma, Allergy and Lung Biology, King's College London, London, UK.
2
Infirst Healthcare Ltd, London, UK.
3
Spica Consultants Ltd, Marlborough, UK.
4
Hull York Medical School, Castle Hill Hospital, East Yorkshire, UK.

Abstract

OBJECTIVES:

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.

DESIGN:

A multicentre, randomised, parallel group, controlled, single-blinded study in participants with acute upper respiratory tract infection-associated cough.

SETTING:

4 general practitioner (GP) surgeries and 14 pharmacies in the UK.

PARTICIPANTS:

Participants aged ≥18 years who self-referred to a GP or pharmacist with acute cough of <7 days' duration. Participant inclusion criterion was cough severity ≥60 mm on a 0-100 mm visual analogue scale (VAS). Exclusion criteria included current smokers or history of smoking within the past 12 months (including e-cigarettes). 163 participants were randomised to the study (mean participant age 38 years, 57% females).

INTERVENTIONS:

Participants were randomised to CS1002 (Unicough) or simple linctus (SL), a widely used cough treatment, and treatment duration was 7 days or until resolution of cough.

MAIN OUTCOME MEASURES:

The primary analysis was intention-to-treat (157 participants) and comprised cough severity assessed using a VAS after 3 days' 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.

RESULTS:

At day 4 (primary end point), the adjusted mean difference (95% CI) in cough severity VAS between CS1002 and SL was -5.9 mm (-14.4 to 2.7), p=0.18. At the end of the study (day 7) the mean difference in cough severity VAS was -4.2 mm (-12.2 to 3.9), p=0.31. CS1002 was associated with a greater reduction in cough sleep disruption (mean difference -11.6 mm (-20.6 to 2.7), p=0.01) and cough frequency (mean difference -8.1 mm (-16.2 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.

CONCLUSIONS:

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.

TRIAL REGISTRATION NUMBER:

EudraCT number 2014-004255-31.

KEYWORDS:

Controlled clinical trial; Cough; Demulcent; Diphenhydramine; Simple Linctus

PMID:
28093442
PMCID:
PMC5253529
DOI:
10.1136/bmjopen-2016-014112
[Indexed for MEDLINE]
Free PMC Article

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