Characterization of differential patient profiles and therapeutic responses of pharmacy customers for four ambroxol formulations

Abstract

BackgroundAmbroxol relieves cough symptoms based on its secretagogue, anti-inflammatory, anti-oxidant, anti-bacterial, anti-viral, immunomodulatory and local anesthetic effects. The present study was designed to explore differential patient profiles and efficacy against acute respiratory symptoms of four formulations registered as over-the-counter medicines.MethodsNine hundred sixty-five pharmacy customers purchasing one of four branded ambroxol formulations (extended release capsules, adult syrup, pediatric syrup and soft pastilles) filled a questionnaire including a patient-adapted version of the Bronchitis Severity Scale, several questions on degree of impairment by acute cough, time to onset of symptom relief and duration of treatment. Data on pediatric syrup users were entered by their parents. Based on the exploratory character of the study, no hypothesis-testing statistical analysis was applied.ResultsUsers of the pediatric syrup and the pastilles reported somewhat less severe baseline symptoms. The patient-adapted Bronchitis Severity Scale proved feasible as a self-administered tool. Among BSS items, ambroxol formulations improved chest pain while coughing to the largest and sputum to smallest degree (− 75% vs. -40%). Reported efficacy was comparable among formulations with minor differences in favor of the pediatric syrup. Time to onset of symptom relief was less than 60 min in more than 90% of patients and occurred prior to known systemic tmax. Time to onset was the parameter with the greatest differences between formulations, being reported fastest with pastilles and pediatric syrup and, as expected, slowest with extended release capsules. All ambroxol formulations were well tolerated.ConclusionsWe conclude that over-the-counter formulations of ambroxol exhibit comparable user profiles and efficacy. Differences in speed of onset of symptom relief may involve not only those in systemic pharmacokinetics but also local anesthetic effects of immediate release formulations. Differences between pediatric and adult syrup may in part reflect reporting bias.

Pharmacokinetics of Ambroxol Sustained Release (Mucosolvan® Retard) Compared with Other Formulations in Healthy Volunteers

“…A study conducted in 941 individuals who purchased one of four over-the-counter ambroxol formulations (IR soft pastilles, adult and pediatric syrups and ER retard capsules) compared customer profiles and treatment responses using the modified Bronchitis Severity Scale (BSS) [13]. Participants who purchased ER capsules were older (mean age 41.2 years) than those who purchased other ambroxol formulations (adult syrup 39.3 years, pediatric syrup 12.8 years, pastilles 38.2 years).…”

“…Most participants who used pastilles (45.2%) and pediatric syrup (43.4%) reported improvement in symptoms 15-30 min after taking ambroxol, while most participants who used ER capsules (47.8%) and adult syrup (42.1%) reported improvement after 30-60 min. As the t max is 1.0-2.5 h for IR ambroxol and 6.5 h for ER ambroxol, time to onset of symptom relief was likely influenced by local effects of the pastille and syrup formulations, as well as the placebo effect [13]. The results of this study of treatment responses in individuals who purchased over-the-counter ambroxol formulations provide real-world evidence to support the use of ER ambroxol in the treatment of acute respiratory conditions.…”

Impact of Neck and/or Shoulder Pain on Headache

“…In line with the frequent use of self-treatment among TTH and migraine sufferers [12], we had chosen to perform a pharmacy-based consumer survey. This tool has proven useful in exploratory studies in various indications with frequent self-medication, for instance in the use of ambroxol in acute cough [17] or fixed-dose combination of ibuprofen and pseudoephedrine in upper respiratory tract infections associated to common cold [18]. While this tool is suitable for comparisons between groups, in contrast to randomized, controlled trials is not suitable to prove efficacy.…”

Effectiveness and tolerability of the thyme/ivy herbal fluid extract BNO 1200 for the treatment of acute cough: an observational pharmacy-based study

“…The BSS is a validated, acute bronchitis-symptom specific questionnaire 16 . Here, a patient-adapted version of the BSS was used to measure the severity of cough and associated symptoms 17 . In total, five items were assessed: cough, sputum (sputum production/expectoration), rattles, chest pain during coughing and dyspnea.…”