Pneumologie 2018; 72(S 01): S88
DOI: 10.1055/s-0037-1619352
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: COPD I
Georg Thieme Verlag KG Stuttgart · New York

Real World Evidence data – pharmacy base survey on different patient profils characterisation and therapeutic responses for ambroxol in the OTC setting

U Sent
1   Medical Affairs Consumer Health Care, Sanofi Aventis Deutschland GmbH
,
P Kardos
2   Pneumologische Praxis, Frankfurt a.M.
,
KM Beeh
3   Insaf Institut für Atemwegsforschung, Wiesbaden
,
M Michel
4   Dept of Pharmacology, Johannes Gutenberg University, Mainz
,
T Mück
1   Medical Affairs Consumer Health Care, Sanofi Aventis Deutschland GmbH
,
H Gräter
1   Medical Affairs Consumer Health Care, Sanofi Aventis Deutschland GmbH
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

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Background:

Ambroxol reliefs 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.

Methods:

965 pharmacy customers purchasing one of four branded ambroxol formulations (Mucosolvan® ER capsules, adult syrup, pediatric syrup and soft pastilles) filled a questionnaire including a patient-adapted version of the Bronchitis Severity Scale (BSS), 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 the parents. Based on the exploratory character of the study, no hypothesis-testing statistical analysis was applied.

Results:

Users of the pediatric syrup and the pastilles reported somewhat less severe baseline symptoms. The BSS 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%). 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 slowest with ER capsules. All ambroxol formulations were well tolerated.

Conclusions:

We 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.