Introduction CS1002 contains diphenhydramine/ammonium-chloride/levomenthol in a demulcent preparation. We conducted a randomised controlled trial to compare the efficacy of CS1002 with Bell’s Simple Linctus (BSL).

Methods 163 subjects with acute cough associated with upper respiratory tract infection, URTI (onset ≤7 days and cough severity VAS ≥60 mm), presenting to pharmacists (64%) or general practitioners were randomised to CS1002 or BSL. The subjects (mean age 39 years, 57% female) were instructed to take their medication four times daily (5/5/10/10 ml) for 7 days or until resolution. Investigators were blinded to the treatment allocation. The primary analysis, cough severity VAS (0–100) was ANCOVA in an intention to treat population.

Results CS1002 (n = 82) compared to BSL (n = 75), after 3 days, was associated with a greater reduction in cough severity (adjusted mean(SE) difference 5.9 (4.3), p = 0.18), cough sleep disruption VAS (mean diff 11.6 (4.5), p = 0.01) and cough frequency VAS (mean diff 8.1 (4.1), p = 0.05, Figure 1). There was a greater improvement in QOL (LCQ-acute) with CS1002 compared to BSL after 5 days; mean diff 1.2 (0.6), p = 0.04. The reduction in cough severity with CS1002 was similar in dry/chesty/tickly categories of cough. Cough resolved after 3 days in 24.4% of CS1002 subjects compared to 10.7% BSL, p = 0.02. CS1002 was well tolerated, similar to BSL.

In conclusion We have conducted the largest RCT in URTI with validated outcome measures. CS1002 reduced the impact of cough associated with URTI with a greater reduction in cough frequency and sleep disruption and improvement in QOL and cough resolution compared to BSL.

• Download figure
• Open in new tab
• Download powerpoint

Abstract S29 Figure 1

Change in cough frequency over time (Full Analysis Set)