Trial · NCT05955885
Effect of Over-the-counter NSAIDS on Cough Reflex Sensitivity in Patients with Upper Respiratory Tract Infections
NCT05955885, Early phase 1, Completed, University of Melbourne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Over-the-counter NSAIDS on Cough Reflex Sensitivity in Patients with Upper Respiratory Tract Infections. Trials, record NCT05955885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05955885
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Over-the-counter NSAIDS on Cough Reflex Sensitivity in Patients with Upper Respiratory Tract Infections
- NCT number
- NCT05955885
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 101 participants, actual
- Lead sponsor
- University of Melbourne
- Conditions
- Cough, Upper Respiratory Tract Infections
- Interventions
- Flurbiprofen Oral Lozenge, Difflam, Flurbiprofen 8.75 MG
- First posted
- 2023-07-21
- Last updated
- 2024-12-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in objective measures of cough sensitivity | Cough challenge testing will be performed at baseline and 3 hours after intervention. | Participants' cough sensitivity thresholds will be measured by inhaled cough challenge testing. This involves participants inhaling single breaths of increasing concentrations of a tussigenic stimulus (capsaicin; (active component of hot chili peppers) as well as saline control to determine threshold doses that elicit an urge to cough, two coughs (C2) and five coughs (C5). The principal endpoint is measured as the change in capsaicin concentration needed to elicit cough responses and the unit of measure is micromolar. |
| Secondary | Change in Cold Symptoms Questionnaire (CSQ) score | Participant self-reports using the Cold Symptoms Questionnaire at baseline and every 30 min after invention until 3 hours has elapsed. | Participants will be asked to self-report on their cold symptom severity using the Cold Symptoms Questionnaire. Each item requires rating on a 10-point Likert scale from 1 to 10. A higher score indicates a worse outcome. The principal endpoint is measured as the change in Cold Symptoms Questionnaire score and the unit of measure is points. |
| Secondary | Change in levels of inflammatory markers in nasal fluid samples | Nasal fluid samples will be taken at baseline and at 3 hours post-intervention. | Samples of nasal fluid will be taken from participants and levels of inflammatory markers such as prostaglandins will be measured using liquid chromatography-mass spectroscopy. The principle endpoint is measured as change in levels and the unit of measure is points. A higher score indicates a better outcome. |
| Secondary | Change in levels of inflammatory markers in saliva samples | Saliva samples will be taken at baseline and at 3 hours post-intervention. | Samples of saliva will be taken from participants and levels of inflammatory markers such as prostaglandins will be measured using liquid chromatography-mass spectroscopy. The principle endpoint is measured as change in levels and the unit of measure is points. A higher score indicates a better outcome. |
| Secondary | Change in levels of inflammatory markers in pharyngeal lavage samples | Pharyngeal lavage samples will be taken at baseline and at 3 hours post-intervention. | Samples of pharyngeal fluid and tissue will be collected from a lavage and levels of inflammatory markers such as prostaglandins will be measured using liquid chromatography-mass spectroscopy. The principle endpoint is measured as change in levels and the unit of measure is points. A higher score indicates a better outcome. |
| Secondary | Patients' Global Impression of Change score | Participants self-report using the Patients' Global Impression of Change score at 3 hours post-intervention. | Participants will self-report on their overall impression of whether the intervention they received resulted in any perceivable changes in their coughing/urge-to-cough. This questionnaire contains mixed items, including items that require rating of degree of change of symptoms on a 10 point Likert scale. The principal endpoint is the score for each item and the unit of measure is points.A higher score indicates a worse outocme. |
| Other | Leicester Cough Questionnaire - Acute score | Participants self-report using the Leicester Cough Questionnaire at baseline. | Participants will be asked to self-report on the impact of cough on their quality of life to enable a measurement of how severe their cough is at baseline. Each item requires a rating on a 7-point Likert scale from 1 to 7 and is related to the impact of cough in one of three domains (physical, psychological social). The Leicester Cough Questionnaire is scored by averaging the ratings in each domain and then adding the average domain scores (range 3-21). A higher score indicates a better outcome. The principal endpoint is measured as the overall Leicester Cough Questionnaire score and the unit of measure is points. |
| Other | Optional: Acute Cough Scale (ACS) score | Participants self-report using the Acute Cough Scale at baseline. | Inclusion of this scale is exploratory and participants may choose to do it. It is new, alternative scale to a Visual Analogue Scale that enables the respondent to describe their cough in a more detailed fashion through 13 items that capture specific dimensions of cough and using a 6 point Likert scale from 0 to 5 with cues given at each grade. The principle endpoint is measured as total score and the unit of measure is points. A higher score indicates a greater severity of cough and disturbance to daily well-being, i.e. worse outcome. |
| Other | Optional: 8-item Quality of Life General (QGEN-8) survey | Participants self-report using the 8-item Quality of Life General survey at baseline. | Inclusion of this scale is exploratory and participants may choose to do it. It is new survey that condenses the numerous items measuring functional health and well-being in other, lengthy health-related quality of life surveys into an 8-item survey that reduces the time and effort burden on survey respondents. It also extends the measurement range to reduce ceiling effects commonly noted in the functioning and feeling domains. The principle endpoint is measured as total score and the unit of measure is points. A higher score indicates a greater quality of life. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05955885
GET https://conductscience.org/api/trials/v1/NCT05955885/registered