Clinical trial NCT05955885: Effect of Over-the-counter NSAIDS on Cough Reflex Sensitivity in Patients with Upper Respiratory Tract Infections
Official title: Effect of Over-the-counter Non-steroidal Anti-inflammatory Treatments on Cough Reflex Sensitivity in Subjects with Upper Respiratory Tract Infection
Conditions: Cough
Upper Respiratory Tract Infections
Summary: The goal of this mechanism of disease study is to investigate the effect of flurbiprofen, a non-steroidal anti-inflammatory drug (NSAID), on the cough hypersensitivity associated with upper respiratory tract infections (URTI).
The main questions it aims to answer are:
* Q1: Does a single treatment with an approved therapeutic dose of flurbiprofen, an NSAID that prevents the production of prostaglandins, acutely reduce objective measures of cough hypersensitivity in participants with URTI?
* Q2: Is the effect of flurbiprofen on cough hypersensitivity in URTI related to participant subjective ratings of acute cough severity?
* Q3: Is the effect of flurbiprofen on cough hypersensitivity in URTI related to the levels of prostaglandins or other inflammatory markers measurable in upper airway secretions?
Participants will be asked to undergo cough challenge testing, complete quality of life questionnaires, and have their nasal fluid, saliva and pharyngeal secretions sampled before and after a single treatment with flurbiprofen in the form of a lozenge or spray. Participants in the comparator arms of the study will instead receive a placebo lozenge or low dose flurbiprofen spray.
Interventions:
description: This commercially available, over-the-counter lozenge manufactured by Reckitt Benckiser contains flurbiprofen as the active ingredient and is registered for the short-term treatment of sore throat associated with upper respiratory tract infections in people over the age of 12 years.
name: Flurbiprofen Oral Lozenge
other_name: Strepfen Intensive Lozenge - Honey and Lemon Flavour
type: Drug
description: This is a non-medicated, control lozenge that is the same flavour as the experimental lozenge that is marketed to help soothe dry, tickly throats while supporting the body's immune health.
name: Difflam
other_name: Difflam Soothing Drops + Immune Support Honey & Lemon Flavour
type: Drug
description: This commercially available, over-the-counter spray manufactured by Reckitt Benckiser contains flurbiprofen as the active ingredient and is registered for the short-term treatment of sore throat associated with upper respiratory tract infections in people over the age of 12 years. It requires 3 actuations of the spray to deliver the full 8.75 dose. Here, a low dose control can be delivered by only performing 1 actuation of the spray.
name: Flurbiprofen 8.75 MG
other_name: Strepfen Intensive Oromucosal Spray; Strepsils Intensive Oromucosal Spray
type: Drug
Study arms:
design_group_description: 30 participants will be asked to suck one (1) flurbiprofen 8.75 mg honey and lemon lozenge (tradename: Strepfen) until dissolved.
design_group_title: Flurbiprofen Oral Lozenge
design_group_type: Experimental
design_group_description: 30 participants will be asked to suck one (1) non-medicated Difflam Soothing Drops + Immune Support Honey & Lemon flavour lozenge until dissolved.
design_group_title: Placebo lozenge
design_group_type: Placebo Comparator
design_group_description: 30 participants will be asked to perform three (3) oral actuations (2.91 mg per actuation) of flurbiprofen 8.75mg spray.
design_group_title: Flurbiprofen 8.75 MG
design_group_type: Experimental
design_group_description: 30 participants will be asked to perform one (1) oral actuation of flurbiprofen 8.75 mg spray, equivalent to a 2.91mg dosage. This will serve a a low dose control as there is no placebo spray available.
design_group_title: Low dose flurbiprofen spray
design_group_type: Other
Sponsor: University of Melbourne
Collaborators: Reckitt Benckiser LLC
Drug name mappings:
name: 氟比洛芬
lang: CN
name: Flurbiprofen
lang: EN
name: フルルビプロフェン
lang: JP