A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03415269|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cough||Drug: Ambroxol Hydrochloride||Phase 2|
Cough is the 5th most common presenting complaint in adults. Cough results from the stimulation of two types of afferent pathways whose receptors are located within the airway epithelium. These include rapidly adapting receptors (RARs) and C-fibre receptors. 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. Indeed, little consensus exists regarding the optimal treatment of acute cough because of the lack of standardised outcome measures for cough. 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 exploratory study will enable us to identify the cough challenge agent (CCA) that is most sensitive to the effect of ambroxol on cough reflex. This is expected to provide a reproducible response, to use in future studies.
This will be an open label, study in subjects with acute cough associated with URTI.
There will be a Screening/Baseline and combined Treatment visit. Subjects will return approximately 1-4 weeks after their treatment once all symptoms have subsided and the subject is no longer suffering from URTI, for a Follow-up Visit.
Up to 14 subjects with acute cough in relation to a URTI and who meet all entry criteria will be assigned to:
Treatment p.o 20 mg ambroxol lozenge (Lysopain Ambr MintM)
At Baseline and post treatment, cough sensitivity will be measured by standard clinical methodology incorporating a series of four cough challenges (citric acid, capsaicin, ATP and distilled water).
Screening/baseline visit 1a The Screening and Baseline visit will ensure that each subject meets all the specified inclusion and none of the exclusion criteria.
Treatment phase visit 1b Subjects who satisfy all entry criteria at baseline will be administered 20 mg ambroxol in the form of a lozenge which must be sucked until fully dissolved in the mouth.
The treatment will be administered in the afternoon of the same visit day as the screening/baseline assessments.
The series of abbreviated cough challenges will be conducted at 30 min and 90 min post dose.
Telephone contact Patients will be contacted by telephone once a week to determine if all symptoms associated with URTI have abated. Once this is confirmed patient will be booked in for the follow-up visit.
Follow-Up Phase Subjects will return within 4 weeks after treatment for a Follow-Up Visit once symptoms of URTI have abated. A series of full cough challenges will be performed at this vist to determine reduction in cough hypersensitivity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official 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.|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||May 2018|
Experimental: 20 mg ambroxol
20 mg ambroxol lozenge delivered once on one day
Drug: Ambroxol Hydrochloride
single lozenge of 20mg ambroxol
Other Name: Lysopain Ambr Mint™
- Cough reflex sensitivity [ Time Frame: 8 hours ]To assess the effect of single dose of 20 mg ambroxol lozenge on cough reflex sensitivity (quatified by recording the concenteration of cough stimulant evoking 2 (C2) and 5 (C5 ) coughs) to four different types of challenge agents in acute cough associated with URTI.
- Severity of cough Visual analogue scale (VAS) [ Time Frame: 90 min post dose ]To determine the effect of single dose of 20 mg ambroxol lozenge on cough severity Visual analogue Scale from baseline compared to 30 min and 90 min post ambroxol 20 mg. The visual analogue scale will comprise of a 100mm horizontal line representing a scale of cough severity from 'No Cough' at the left hand (0 mm) end of the line up to 'Worst Cough'(100mm) at the right hand end. The participant will be instructed to draw a single vertical line on the scale to indicate how severe they felt their cough has been during a specified time.
- Urge to cough Visual analogue scale (VAS) [ Time Frame: 90 min post dose ]To determine the effect of single dose of 20 mg ambroxol lozenge on urge to cough VAS from baseline compared to 30 min and 90 min post ambroxol 20 mg The Visual analogue scale will be a 100mm scale used to record the severity of their urge to cough but marked at the extremes as 'No urge-to-cough' on the left side (0mm) and 'Worst urge-to-cough' (100 mm) on the right side. The participant is instructed to draw a single vertical line on the scale to indicate how severe their urge to cough was during a specified time.
- Change in cough reflex sensitivity from during acute cough to post symptom recovery [ Time Frame: up tp 1 month ]measure change in cough reflex sensitivity to citric acid, capsaicin, ATP and distilled water as measured using the C2 and C5 and compare this to that measured post symptom recovery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415269
|Contact: Caroline E Wright, BSc||+44 1482 firstname.lastname@example.org|
|Contact: Susannah Thackray-Nocera, RCN||+44 1482 624009||susannah.Thackray-Nocera@hey.nhs.uk|
|Castle Hill Hospital|
|Cottingham, East Yorkshire, United Kingdom, HU16 5JQ|
|Principal Investigator:||Alyn H Morice||Hull and East Yorkshire Hospitals NHS Trust|