None listed
Conditions
Brief summary
Persistent upper airway symptoms such as postnasal drip (PND), throat clearing, mucus sensation, and chronic cough are common patient complaints, that can significantly impair quality of life. These symptoms are often secondary to active allergy and reflux, and as a result, commonly improve but not always fully resolve, following management of these types of primary conditions. Given the lack of a direct treatment standard targeting residual symptoms, and their association with a sensory irritation origin, this study will investigate the effectiveness of persistent blockade of the "cold sensor", TRPM8, receptor using oral lozenges for the management of postnasal drip and mucus symptoms.
Interventions
Participants will be provided with a week supply of each oral lozenge type, readily available on the market, with a honey lemon flavor and containing either high (21 mg), low (7 mg) or no menthol at baseline clinic visit, The order of the lozenge type administration will be pre-determined at baseline (ether: 1: high, low, placebo; OR 2: high, placebo, low; OR 3: low, high, placebo; OR 4: low, placebo, high; OR 5: placebo, high, low; OR 6: placebo, low, high) and self-administered by participants
Participants will be provided with a week supply of each oral lozenge type, readily available on the market, with a honey lemon flavor and containing either high (21 mg), low (7 mg) or no menthol at baseline clinic visit, The order of the lozenge type administration will be pre-determined at baseline (ether: 1: high, low, placebo; OR 2: high, placebo, low; OR 3: low, high, placebo; OR 4: low, placebo, high; OR 5: placebo, high, low; OR 6: placebo, low, high) and self-administered by participants every 2 hours or as needed daily for 7 days, with a washout period of 7 days, The process is then repeated for the remaining two lozenge types, with a total of 6 weeks duration for the entire study (i.e. inclusive of treatment and washout periods). At the end of each week, participants will complete a quick online questionnaire that will assess their lozenge adherence and symptoms. A study investigator will be in contact with participants on a weekly basis via email or over the phone to clarify questions and monitor progress.
Sponsors
Richard Harvey - Head of the Rhinology and Skull Base Research Group at St Vincent's Centre for Applied Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients with a strong and persistent sensation of post-nasal mucus, throat clearing, lumpiness and cough despite active allergy and reflux management. Body weight: A minimum body weight >=40 kilograms (kg) at enrolment. Gender: Male or female. Informed consent: Capable of giving signed written informed consent and willingness to participate to and comply with the study.
Exclusion criteria
Diagnosis with active sinus or lung disease. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. History of diabetes mellitus or intolerance to trace amounts of milk, almond, peanut, macadamia or soy.
Outcome results
None listed