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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03722849
Registration number
NCT03722849
Ethics application status
Date submitted
24/10/2018
Date registered
29/10/2018
Date last updated
15/06/2022
Titles & IDs
Public title
Functional Magnetic Resonance Imaging of ATP Cough in Chronic Cough Patients
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Scientific title
A Functional Magnetic Resonance Imaging Study to Investigate ATP-sensitive Cough Neural Pathways in Patients With Chronic Cough Hypersensitivity
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Secondary ID [1]
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Study 58136
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cough
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Adenosine Triphosphate
Treatment: Drugs - Capsaicin
Other interventions - Functional Brain Imaging
Experimental: Chronic cough participant - Twenty-five (25) Idiopathic chronic cough patients, defined as refractory to disease modifying therapies (eg anti-asthma medications), will be recruited.
Participants will attend two sessions. In the first they will inhale in a single breath a nebulized solutions of increasing doses of Adenosine Triphosphate (ATP; 0.2-300 microM) and capsaicin (0.5-125 microM) to determine their individual cough and urge-to-cough thresholds. In the second session, participants will undergo functional brain imaging (fMRI) for 1 hour while inhaling over 24 seconds randomly administered nebulized solutions of saline, or threshold doses of ATP or capsaicin.
Experimental: Healthy control participant - Twenty-five (25) appropriately age and sex matched healthy non-smoking individuals will be recruited as the comparison group.
Participants will attend two sessions. In the first they will inhale in a single breath a nebulized solutions of increasing doses of ATP (0.2-300 microM) and capsaicin (0.5-125 microM) to determine their individual cough and urge-to-cough thresholds. In the second session, participants will undergo fMRI for 1 hour while inhaling over 24 seconds randomly administered nebulized solutions of saline, or threshold doses of ATP or capsaicin.
Treatment: Drugs: Adenosine Triphosphate
Participants will inhale escalating concentrations of Adenosine Triphosphate (ATP) to induce cough and the urge-to-cough
Treatment: Drugs: Capsaicin
Participants will inhale escalating concentrations of capsaicin to induce cough and the urge-to-cough
Other interventions: Functional Brain Imaging
Participants will have scans of their brain activity using 3 Tesla (3T) brainstem restricted functional brain imaging (fMRI)
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Brainstem neural activations
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Assessment method [1]
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fMRI will be used to determine the location and magnitude of neural responses in the brain during ATP and capsaicin inhalation. fMRI non-invasively measures Blood Oxygen Level Dependent (BOLD) signals in the brain which can be used to identify regions of the brain that increase activity associated with the inhaled stimuli. Comparisons between regional BOLD responses evoked by ATP and capsaicin (compared to saline) will allow the different neural networks involved in cough generation to be explored in healthy and chronic cough participants.
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Timepoint [1]
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18 months
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Secondary outcome [1]
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Behavioral responses
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Assessment method [1]
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Participant responses (cough and the urge-to-cough) evoked by ATP and capsaicin will be measured by counting audible coughs and by asking participants to rate their perception of urge-to-cough using visual analogue scales (VAS).
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Timepoint [1]
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18 months
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Eligibility
Key inclusion criteria
- Patients with physician diagnosed chronic refractory cough (cough lasting >8 weeks).
- > 18 years of age
- Must be cognitively impaired
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- People with contraindications to MRI scanning (i.e. metal implants, claustrophobia).
- History of uncontrolled asthma or chronic respiratory disease (other than refractory
cough).
- Evidence of an allergic reaction to capsaicin (chilli).
- Pregnant women.
- Smoking, current or recent history (last 6 months).
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/05/2022
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Sample size
Target
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Accrual to date
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Final
58
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The University of Melbourne - Parkville
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Recruitment postcode(s) [1]
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3010 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Stuart Mazzone
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Imperial College London
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Queen's University, Belfast
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Monash University
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Ethics approval
Ethics application status
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Summary
Brief summary
Persistent cough is a distressing symptom for people with respiratory disorders. Patients
also often experience an ongoing urge-to-cough that prompts coughing, and which fails to
resolve the sensation. Understanding how the brain controls cough and the urge-to-cough could
lead to new cough suppressing therapies. The overall objective of this project is to use
functional brain imaging (fMRI) to identify brain regions that are involved in the
exaggerated urge-to-cough in humans with chronic cough. Our focus will be on the brainstem
where information from the airways first arrives in the central nervous system.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03722849
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Trial related presentations / publications
Chung KF, Pavord ID. Prevalence, pathogenesis, and causes of chronic cough. Lancet. 2008 Apr 19;371(9621):1364-74. doi: 10.1016/S0140-6736(08)60595-4.
Morice AH, Jakes AD, Faruqi S, Birring SS, McGarvey L, Canning B, Smith JA, Parker SM, Chung KF, Lai K, Pavord ID, van den Berg J, Song WJ, Millqvist E, Farrell MJ, Mazzone SB, Dicpinigaitis P; Chronic Cough Registry. A worldwide survey of chronic cough: a manifestation of enhanced somatosensory response. Eur Respir J. 2014 Nov;44(5):1149-55. doi: 10.1183/09031936.00217813. Epub 2014 Sep 3.
Chung KF, McGarvey L, Mazzone SB. Chronic cough as a neuropathic disorder. Lancet Respir Med. 2013 Jul;1(5):414-22. doi: 10.1016/S2213-2600(13)70043-2. Epub 2013 May 3.
Mazzone SB, McLennan L, McGovern AE, Egan GF, Farrell MJ. Representation of capsaicin-evoked urge-to-cough in the human brain using functional magnetic resonance imaging. Am J Respir Crit Care Med. 2007 Aug 15;176(4):327-32. doi: 10.1164/rccm.200612-1856OC. Epub 2007 Jun 15.
Ando A, Smallwood D, McMahon M, Irving L, Mazzone SB, Farrell MJ. Neural correlates of cough hypersensitivity in humans: evidence for central sensitisation and dysfunctional inhibitory control. Thorax. 2016 Apr;71(4):323-9. doi: 10.1136/thoraxjnl-2015-207425. Epub 2016 Feb 9.
Abdulqawi R, Dockry R, Holt K, Layton G, McCarthy BG, Ford AP, Smith JA. P2X3 receptor antagonist (AF-219) in refractory chronic cough: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2015 Mar 28;385(9974):1198-205. doi: 10.1016/S0140-6736(14)61255-1. Epub 2014 Nov 25.
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Public notes
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Contacts
Principal investigator
Name
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Stuart Mazzone, PhD
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Address
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University of Melbourne
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03722849
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