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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05955885




Registration number
NCT05955885
Ethics application status
Date submitted
11/07/2023
Date registered
21/07/2023

Titles & IDs
Public title
Effect of Over-the-counter NSAIDS on Cough Reflex Sensitivity in Patients With Upper Respiratory Tract Infections
Scientific title
Effect of Over-the-counter Non-steroidal Anti-inflammatory Treatments on Cough Reflex Sensitivity in Subjects With Upper Respiratory Tract Infection
Secondary ID [1] 0 0
25925
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cough 0 0
Upper Respiratory Tract Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Flurbiprofen Oral Lozenge
Treatment: Drugs - Difflam
Treatment: Drugs - Flurbiprofen 8.75 MG

Experimental: Flurbiprofen Oral Lozenge - 30 participants will be asked to suck one (1) flurbiprofen 8.75 mg honey and lemon lozenge (tradename: Strepfen) until dissolved.

Placebo comparator: Placebo lozenge - 30 participants will be asked to suck one (1) non-medicated Difflam Soothing Drops + Immune Support Honey \& Lemon flavour lozenge until dissolved.

Experimental: Flurbiprofen 8.75 MG - 30 participants will be asked to perform three (3) oral actuations (2.91 mg per actuation) of flurbiprofen 8.75mg spray.

Other: Low dose flurbiprofen spray - 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.


Treatment: Drugs: Flurbiprofen Oral Lozenge
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.

Treatment: Drugs: Difflam
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.

Treatment: Drugs: Flurbiprofen 8.75 MG
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in objective measures of cough sensitivity
Timepoint [1] 0 0
Cough challenge testing will be performed at baseline and 3 hours after intervention.
Secondary outcome [1] 0 0
Change in Cold Symptoms Questionnaire (CSQ) score
Timepoint [1] 0 0
Participant self-reports using the Cold Symptoms Questionnaire at baseline and every 30 min after invention until 3 hours has elapsed.
Secondary outcome [2] 0 0
Change in levels of inflammatory markers in nasal fluid samples
Timepoint [2] 0 0
Nasal fluid samples will be taken at baseline and at 3 hours post-intervention.
Secondary outcome [3] 0 0
Change in levels of inflammatory markers in saliva samples
Timepoint [3] 0 0
Saliva samples will be taken at baseline and at 3 hours post-intervention.
Secondary outcome [4] 0 0
Change in levels of inflammatory markers in pharyngeal lavage samples
Timepoint [4] 0 0
Pharyngeal lavage samples will be taken at baseline and at 3 hours post-intervention.
Secondary outcome [5] 0 0
Patients' Global Impression of Change score
Timepoint [5] 0 0
Participants self-report using the Patients' Global Impression of Change score at 3 hours post-intervention.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 cough;
* Prior experience of an allergic or bad reaction to capsaicin or chilli (which is rare);
* Prior experience an allergic or bad reaction to a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen;
* Ongoing or history of stomach ulcer, impaired kidney or liver function, or heart failure;
* Pregnancy, lactation or actively trying to become pregnant;
* Currently taking other products with flurbiprofen, aspirin or other anti-inflammatory medicines;
* Evidence of COVID-19 positivity, either during the COVID Rapid Antigen Test administered on the day of assessment or have informed us that they have become positive in the 24-48 hours after the testing session (i.e., participants who were likely positive during assessment but under the detection threshold);
* Participants who cannot provide informed voluntary consent.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Carlton
Recruitment postcode(s) [1] 0 0
3010 - Carlton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Reckitt Benckiser LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stuart Mazzone, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stuart Mazzone, PhD
Address 0 0
Country 0 0
Phone 0 0
+61383446457
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05955885