A study of the effect of 20 mg ambroxol hydrochloride on cough refex
Research type
Research Study
Full title
A single-Centre, open-label, exploratory study of the effect of 20 mg ambroxol hydrochloride on cough reflex sensitivity in patients with acute cough.
IRAS ID
235752
Contact name
Alyn Morice
Contact email
Sponsor organisation
Hull & East Yorkshire Hospitals NHS Trust
Eudract number
2017-003980-36
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
Cough is the 5th most common presenting complaint in adults. Acute as well as chronic, non-productive cough, which often follow viral upper respiratory tract infection, may result from increased sensitivity of the cough reflex. Relatively little research has been done to gain insight into the mechanisms of cough in health and disease, and to properly evaluate potential antitussive therapies. Possibly the most significant clinical need in terms of cough therapy is for the cough associated with an acute upper respiratory tract infection (URTI). Although the cough associated with URTI is often self-limiting and resolves within several days, it undoubtedly accounts for a major proportion of huge worldwide expenditure of over-the-counter (OTC) cough and cold products where patients are still struggling to find an effective medication.
This single centre, open label, exploratory study in 14 patients with acute cough,is to investigate whether treatment with 20 mg ambroxol in patients with acute cough results in a sufficient signal, i.e. a reasonable trend that ambroxol reduces the cough reflex, which would then warrant further investigation (phase III RCT). Cough reflex sensitivity will be measured in this study by using a methosd of artificially induced cough through inhalation of 4 different types (citric acid, capsaicin, ATP and distilled water) of cough stimulant (cough challenges). Cough challenges will be performed before and after ambroxol administration and we will look to see if there is a reduction in cough sensitivity to the challenge agents following Ambroxol.
In addition, this study shall aim to identify which challenge agent would be most appropriate to use in subsequent clinical trials.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0409
Date of REC Opinion
26 Jan 2018
REC opinion
Further Information Favourable Opinion