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Cough Update: Efficacy of an over-the-counter medicine in acute cough

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eMediNexus    25 February 2021

CS1002 is an over-the-counter coughmedicine containing three active ingredients – diphenhydramine, levomenthol andammonium chloride in a cocoa-based demulcent formulation.

The objective of this study was to examinethe efficacy and safety of CS1002, in a cocoa-based demulcent. A multicentre,parallel group, randomised, controlled and single-blinded study in volunteerswith acute upper respiratory tract infection-associated cough was conducted

Participants aged ≥18 years who hadself-referred to a general practitioner or pharmacist with acute cough of <7days duration had enrolled. The inclusion criterion was cough severity ≥60 mmon a 0-100 mm visual analogue scale (VAS). The exclusion criteria involvedexisting smokers or history of smoking in the last 12 months. 163 participantswere randomised to CS1002 (Unicough) or simple linctus (SL), which is acommonly used cough syrup. The treatment duration was 7 days or till theresolution of cough.

The results of the study at day 4 (primaryend point) showed that the adjusted mean difference in cough severity VASbetween CS1002 and SL was -5.9 mm. And at the end of the study i.e., day 7, themean difference in cough severity VAS was -4.2 mm. CS1002 was associated with agreater decrease in cough sleep disruption (mean difference -11.6 mm) and coughfrequency (mean difference -8.1 mm) as compared with SL. A greater improvementin Leicester Cough Questionnaire -acute quality of life scores with CS1002 wasobserved as compared with SL after 5 days treatment.

Many participants prematurely had stoppedthe treatment because of cough improvement in the CS1002 group (24.4%) ascompared with SL (10.7%). Adverse events were 20.5% in CS1002 group and 27.6%in SL. 6 of the participants (i.e.,7%) in the CS1002 group reduced themedication dose due to drowsiness that later resolved.

The study concluded that even though theprimary end point was not achieved, CS1002 was associated with greaterreductions in the frequency of cough, sleep disruption and improved healthquality as compared with SL.

Ref: Birring SS, Brew J, Kilbourn A, etal. Rococo study: a real-world evaluation of an over-the-counter medicine inacute cough (a multicentre, randomised, controlled study). BMJ Open. 2017 Jan 16;7(1):e014112.

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