Efficacy and Safety of Levocloperastine in the Treatment of Dry Cough: A Prospective Observational Study

Abstract

Purpose/aim: To evaluate effectiveness and safety of Levocloperastine in the treatment of dry cough in adult Indian patients.

Methods: In this prospective, observational study, patients aged 18-60 years, presenting with dry cough and prescribed with Levocloperastine at baseline or a day prior to enrolment, as per standard clinical practice, were recruited from 3 centers in India. The scores of cough severity (100 mm VAS), cough frequency since last 24 h (7-point Likert scale), sleep disruption due to night-time awakenings (10 cm VAS), quality of life (QoL) (Leicester Cough Questionnaire [LCQ]), and number of days for achieving minimal important difference (MID) in cough severity (17 mm improvement on VAS) were assessed from baseline to Day 14. In addition, physicians' assessment of effectiveness of Levocloperastine at Day 14, adverse drug reactions (ADRs) and proportion of patients reporting sedation and other central nervous system side effects were also reported during the study. Descriptive statistics was used to summarize the data.

Results: A total of 100 patients were enrolled in the study. The mean scores of cough severity, cough frequency and sleep disruption due to night-time awakening were significantly reduced from baseline to Day 14 (p<0.0001). A significant improvement in QoL scores (total and by domain) was noted from baseline to Day 14 (p<0.0001). Post treatment with Levocloperastine, the mean time for achieving MID was 5.3±0.26 days. Disappearance of cough was reported in 44% of patients; 54% patients reported improvement of cough by Day 14. No ADRs, cases of sedation or other side-effects were reported in the study.

Conclusion: Levocloperastine was found to be effective and safe in the management of dry cough. A significant reduction in severity scores, frequency of cough and sleep disruption was reported, with an overall improvement in patient's QoL.