CompletedEarly Phase 1

Effect of Over-the-counter NSAIDS on Cough Reflex Sensitivity in Patients with Upper Respiratory Tract Infections

Australia101 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion Criteria: * An onset of any 2 URTI symptoms in past 3-5 days, such as a sore throat, fever, coughing, coughing up phlegm, sneezing, and runny nose; * A current cough or urge-to-cough rated at least 5 in severity and/or ranking cough as subject's most bothersome symptom on Cold Symptoms Questionnaire (CSQ); * A feeling of sickness interfering with their daily life, rated as at least mildly; * A cough consistent with acute cough - i.e., cough onset with URTI and not ongoing, chronic cough; * Written informed consent and a willingness and ability to comply with the study protocol. Exclusion Criteria: * A pre-existing chronic lung disease (asthma, COPD, chronic bronchitis etc), to exclude these as causes for cough; * The use of inhaled or systemic steroids / broncho-active medication, ACE inhibitors, oral or inhaled antihistamines, opiates, gabapentin, tricyclic antidepressants (current or within the past 3 months), as these will alter airway inflammatory profiles and/ or cough sensitivity; * A current cigarette or marijuana smoker/vaper, recreational drug user, or have given up smoking/vaping within the last 12 months, or a former smoker with greater than 20 pack-years, alter airway inflammatory profiles and/ or cough sensitivity; * Pre-existing chronic cough (cough persisting for more than 8 weeks): unexplained chronic cough (UCC) or refractory chronic cough (RCC) associated with or without a pre-existing condition (GERD, rhinitis, etc), as we are studying acute co…

What they're measuring

Change in objective measures of cough sensitivity

Timeframe: Cough challenge testing will be performed at baseline and 3 hours after intervention.

Trial details

NCT IDNCT05955885

SponsorUniversity of Melbourne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01