CoughNCT03722849
Functional Magnetic Resonance Imaging of ATP Cough in Chronic Cough Patients
A study testing Adenosine Triphosphate, Capsaicin and Functional Brain Imaging in people with Cough, run by Stuart Mazzone at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Adenosine Triphosphate, Capsaicin and Functional Brain Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Mar 2019to 13 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with physician diagnosed chronic refractory cough (cough lasting >8 weeks).
- > 18 years of age
- Must be cognitively impaired
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Functional Magnetic Resonance Imaging Study to Investigate ATP-sensitive Cough Neural Pathways in Patients With Chronic Cough Hypersensitivity
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.
Read the detailed description
Peripheral effects of ATP via P2X3 receptors
ATP has been shown to be a tussive agent particularly on chronic cough patients who were more sensitive than non-cough subjects to inhaled ATP. ATP has been shown to augment the cough response to capsaicin in patients with asthma. Gefapixant at a single oral dose of 50 mg did not modulate capsaicin cough responses in normal volunteers and chronic cough subjects while inhibiting ATP-induced cough particularly in chronic cough subjects. These observations would suggest that ATP has a direct effect on a subset sensory neurons that evoke coughing through the activation of P2X3 receptors.
The use of fMRI to provide insights into the peripheral and central sites of activation by ATP/P2X3 activation We have generated functional brain imaging (fMRI) data to suggest that the different brain circuits in receipt of nodose and jugular ganglia neuron inputs (as identified in animal studies) are conserved in humans. When inhaled, the tussigenic compound capsaicin (from hot chili peppers) indiscriminately stimulates both nodose and jugular chemosensitive afferents and we have published that capsaicin inhalation produces brain activations in the primary sensory, anterior and mid-insula, cingulate, premotor, motor and orbitofrontal cortices. These regions are presumed to encode perceptual awareness of airway irritation, and the associated emotional, cognitive and behavioral (motor) consequences. For example, activity in the human primary sensory cortex (which receives jugular ganglia inputs in animal studies) correlates with an individual's perception of airway irritation (their perceived need/ urge to cough) while activity in the insula (in receipt of nodose inputs) relates closely to the actual magnitude of the delivered stimulus independent of perception. We have now built upon these published findings by using high resolution brainstem fMRI during the inhalation of ATP (expected to only activate P2X2/3 expressing nodose-derived airway afferents) versus capsaicin (expected to activate both jugular and nodose chemosensitive afferents). Our results are striking and reveal that ATP inhalation evokes an in increased signal level in the brainstem regions corresponding to the nTS, while capsaicin inhalation produces activations in both the nTS and in an area of the dorsal spinal trigeminal nucleus on the lateral margins of the brainstem that contains the paratrigeminal nucleus. Indeed, our healthy participants did not cough as much to ATP compared to capsaicin, consistent with studies cough in animals and humans and the relatively poor cough-evoking properties of ATP in healthy humans. However, the perception of airway irritation was identical between ATP and capsaicin stimuli. We believe that cough production will ultimately be dependent upon activation of the neural circuit that integrates in the paratrigeminal nucleus (i.e.' the jugular afferent pathway) and therefore we hypothesize that there is an upregulation of the capacity of ATP to act via jugular ganglia pathways in chronic cough patients.
The fMRI studies described above provide an exciting opportunity to assess for the first time which primary airway afferent pathways are likely excited or sensitized by ATP and, in turn, what aspects of the central processing of airway sensory information is altered by ATP. We have reported previously that patients with chronic cough display functional brain responses consistent with a state of central sensitization that closely resembles the central sensitization accompanying chronic pain.
We will extend upon these findings by determining whether ATP-sensitive pathways in the brainstem and brain are altered in patients with chronic cough, and in doing so provide insight into whether ATP effects vagal afferent processing through an interaction with nodose and/ or jugular neural pathways.
- Conditions
- Cough
- Being tested
- Adenosine Triphosphate, Capsaicin, Functional Brain Imaging
- Keywords
- functional brain imaging, ATP, Capsaicin, Refractory cough
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine TriphosphateDrug
Also called ATP
Participants will inhale escalating concentrations of Adenosine Triphosphate (ATP) to induce cough and the urge-to-cough
CapsaicinDrug
Participants will inhale escalating concentrations of capsaicin to induce cough and the urge-to-cough
Functional Brain ImagingOther
Also called fMRI
Participants will have scans of their brain activity using 3 Tesla (3T) brainstem restricted functional brain imaging (fMRI)
| Study group | Role | What they receive |
|---|---|---|
| Chronic cough participant | Experimental | 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 milliM) 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. Receives: Drug: Adenosine Triphosphate; Drug: Capsaicin; Other: Functional Brain Imaging |
| Healthy control participant | Experimental | 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 milliM) 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. Receives: Drug: Adenosine Triphosphate; Drug: Capsaicin; Other: Functional Brain Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brainstem Neural Activations to Capsaicin
fMRI will be used to determine the location and magnitude of neural responses in the brainstem during Capsaicin inhalation: in particular, the nucleus of the solitary tract and the paratrigeminal nucleus. 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. BOLD signals detected are to be reported as % BOLD signal change in response to Capsaicin greater than control saline.
Measured: fMRI was performed in a single session on the day of the cough challenge testing session and not more than seven days after.
Brainstem Neural Activations to ATP
fMRI will be used to determine the location and magnitude of neural responses in the brainstem during ATP inhalation: in particular, the nucleus of the solitary tract and the paratrigeminal nucleus. 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. BOLD signals detected are to be reported as % BOLD signal change in response to ATP greater than control saline.
Measured: fMRI was performed in a single session on the day of the cough challenge testing session and not more than seven days after.
Secondary outcomes (3)
Behavioral Responses During Cough Challenge Testing: Cough Sensitivity to Capsaicin
Participant responses (cough and the urge-to-cough) evoked by Capsaicin will be measured by counting audible coughs to doubling doses of Capsaicin and by asking participants to rate their perception of urge-to-cough using visual analogue scales (VAS) to each dose. Thresholds for cough sensitivity are to be reported as microM. Cu is the threshold dose required to elicit a non-zero urge-to-cough rating. C2 is the threshold dose required to elicit two audible coughs. Smax is the largest dose that could be inhaled for 24s without eliciting an audible cough. fMRI dose was the dose used during fMRI scanning.
Measured: Thresholds for cough sensitivity were measured during a 1 hr session prior to fMRI scanning
Behavioral Responses During Cough Challenge Testing: Cough Sensitivity to ATP
Participant responses (cough and the urge-to-cough) evoked by ATP will be measured by counting audible coughs to doubling doses of ATP and by asking participants to rate their perception of urge-to-cough using visual analogue scales (VAS) to each dose. Thresholds for cough sensitivity are to be reported as milliM. Cu is the threshold dose required to elicit a non-zero urge-to-cough rating. C2 is the threshold dose required to elicit two audible coughs. Smax is the largest dose that could be inhaled for 24s without eliciting an audible cough. fMRI dose was the dose used during fMRI scanning.
Measured: Thresholds for cough sensitivity were measured during a 1 hr session prior to fMRI scanning
Behavioral Responses to Cough Challenge Testing: Urge to Cough Ratings to Capsaicin and ATP
Participant responses (cough and the urge-to-cough) evoked by ATP will be measured by counting audible coughs to doubling doses of ATP and by asking participants to rate their perception of urge-to-cough using visual analogue scales (VAS) to each dose.Urge-to-cough score is reported by the participant using a Bog scale ranging from 0 (no urge) to 10 (most intense urge imaginable) where the higher score, the worse the outcome. Cu is the threshold dose required to elicit a non-zero urge-to-cough rating. C2 is the threshold dose required to elicit two audible coughs. Smax is the largest dose that could be inhaled for 24s without eliciting an audible cough. fMRI dose was the dose used during fMRI scanning.
Measured: Urge-to-cough ratings were reported during the 1 hour cough challenge testing session and during the subsequent fMRI scanning session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Mar 2019
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The experiment will consist of two sessions. The first session will involve questionnaires, followed by measures of sensitivity and behavioural responses to tussive (cough evoking) stimulation. The second session will involve functional brain imaging measures of responses to tussive stimulation.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stuart Mazzone
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Queen's University, Belfast, Monash University
- Responsible party
- Sponsor-investigator, Stuart Mazzone, University of Melbourne
- Investigators
- Stuart Mazzone, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722849
- Sponsor's protocol ID
- Study 58136
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2018
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
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.
PubMed 18424325Morice 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.
PubMed 25186267Chung 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.
PubMed 24429206Mazzone 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.
PubMed 17575093Ando 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.
PubMed 26860344Abdulqawi 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.
PubMed 25467586
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Functional Magnetic Resonance Imaging Study to Investigate ATP-sensitive Cough Neural Pathways in Patients With Chronic Cough Hypersensitivity
- ClinicalTrials.gov ID
- NCT03722849
- Acronym / sponsor ID
- Study 58136
- Conditions
- Cough
- Keywords
- functional brain imaging, ATP, Capsaicin, Refractory cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Stuart MazzoneUniversity, hospital or other
- Collaborators
- Imperial College London, Queen's University, Belfast, Monash University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 22 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peripheral effects of ATP via P2X3 receptors
ATP has been shown to be a tussive agent particularly on chronic cough patients who were more sensitive than non-cough subjects to inhaled ATP. ATP has been shown to augment the cough response to capsaicin in patients with asthma. Gefapixant at a single oral dose of 50 mg did not modulate capsaicin cough responses in normal volunteers and chronic cough subjects while inhibiting ATP-induced cough particularly in chronic cough subjects. These observations would suggest that ATP has a direct effect on a subset sensory neurons that evoke coughing through the activation of P2X3 receptors.
The use of fMRI to provide insights into the peripheral and central sites of activation by ATP/P2X3 activation We have generated functional brain imaging (fMRI) data to suggest that the different brain circuits in receipt of nodose and jugular ganglia neuron inputs (as identified in animal studies) are conserved in humans. When inhaled, the tussigenic compound capsaicin (from hot chili peppers) indiscriminately stimulates both nodose and jugular chemosensitive afferents and we have published that capsaicin inhalation produces brain activations in the primary sensory, anterior and mid-insula, cingulate, premotor, motor and orbitofrontal cortices. These regions are presumed to encode perceptual awareness of airway irritation, and the associated emotional, cognitive and behavioral (motor) consequences. For example, activity in the human primary sensory cortex (which receives jugular ganglia inputs in animal studies) correlates with an individual's perception of airway irritation (their perceived need/ urge to cough) while activity in the insula (in receipt of nodose inputs) relates closely to the actual magnitude of the delivered stimulus independent of perception. We have now built upon these published findings by using high resolution brainstem fMRI during the inhalation of ATP (expected to only activate P2X2/3 expressing nodose-derived airway afferents) versus capsaicin (expected to activate both jugular and nodose chemosensitive afferents). Our results are striking and reveal that ATP inhalation evokes an in increased signal level in the brainstem regions corresponding to the nTS, while capsaicin inhalation produces activations in both the nTS and in an area of the dorsal spinal trigeminal nucleus on the lateral margins of the brainstem that contains the paratrigeminal nucleus. Indeed, our healthy participants did not cough as much to ATP compared to capsaicin, consistent with studies cough in animals and humans and the relatively poor cough-evoking properties of ATP in healthy humans. However, the perception of airway irritation was identical between ATP and capsaicin stimuli. We believe that cough production will ultimately be dependent upon activation of the neural circuit that integrates in the paratrigeminal nucleus (i.e.' the jugular afferent pathway) and therefore we hypothesize that there is an upregulation of the capacity of ATP to act via jugular ganglia pathways in chronic cough patients.
The fMRI studies described above provide an exciting opportunity to assess for the first time which primary airway afferent pathways are likely excited or sensitized by ATP and, in turn, what aspects of the central processing of airway sensory information is altered by ATP. We have reported previously that patients with chronic cough display functional brain responses consistent with a state of central sensitization that closely resembles the central sensitization accompanying chronic pain.
We will extend upon these findings by determining whether ATP-sensitive pathways in the brainstem and brain are altered in patients with chronic cough, and in doing so provide insight into whether ATP effects vagal afferent processing through an interaction with nodose and/ or jugular neural pathways.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experiment will consist of two sessions. The first session will involve questionnaires, followed by measures of sensitivity and behavioural responses to tussive (cough evoking) stimulation. The second session will involve functional brain imaging measures of responses to tussive stimulation.
| Arm | Type | Receives |
|---|---|---|
| Chronic cough participant | Experimental | Drug: Adenosine Triphosphate, Drug: Capsaicin, Other: Functional Brain ImagingTwenty-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 milliM) 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. |
| Healthy control participant | Experimental | Drug: Adenosine Triphosphate, Drug: Capsaicin, Other: Functional Brain ImagingTwenty-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 milliM) 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with physician diagnosed chronic refractory cough (cough lasting >8 weeks).
- > 18 years of age
- Must be cognitively impaired
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenosine TriphosphateAlso: ATPParticipants will inhale escalating concentrations of Adenosine Triphosphate (ATP) to induce cough and the urge-to-cough | Drug | Chronic cough participant, Healthy control participant |
| CapsaicinParticipants will inhale escalating concentrations of capsaicin to induce cough and the urge-to-cough | Drug | Chronic cough participant, Healthy control participant |
| Functional Brain ImagingAlso: fMRIParticipants will have scans of their brain activity using 3 Tesla (3T) brainstem restricted functional brain imaging (fMRI) | Other | Chronic cough participant, Healthy control participant |
Primary outcome
Brainstem Neural Activations to Capsaicin
Time frame: fMRI was performed in a single session on the day of the cough challenge testing session and not more than seven days after.
fMRI will be used to determine the location and magnitude of neural responses in the brainstem during Capsaicin inhalation: in particular, the nucleus of the solitary tract and the paratrigeminal nucleus. 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. BOLD signals detected are to be reported as % BOLD signal change in response to Capsaicin greater than control saline.
Brainstem Neural Activations to ATP
Time frame: fMRI was performed in a single session on the day of the cough challenge testing session and not more than seven days after.
fMRI will be used to determine the location and magnitude of neural responses in the brainstem during ATP inhalation: in particular, the nucleus of the solitary tract and the paratrigeminal nucleus. 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. BOLD signals detected are to be reported as % BOLD signal change in response to ATP greater than control saline.
3 secondary outcomes
Behavioral Responses During Cough Challenge Testing: Cough Sensitivity to Capsaicin
Time frame: Thresholds for cough sensitivity were measured during a 1 hr session prior to fMRI scanning
Behavioral Responses During Cough Challenge Testing: Cough Sensitivity to ATP
Time frame: Thresholds for cough sensitivity were measured during a 1 hr session prior to fMRI scanning
Behavioral Responses to Cough Challenge Testing: Urge to Cough Ratings to Capsaicin and ATP
Time frame: Urge-to-cough ratings were reported during the 1 hour cough challenge testing session and during the subsequent fMRI scanning session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18424325Chung 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.
- Background: PubMed 25186267Morice 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.
- Background: PubMed 24429206Chung 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.
- Background: PubMed 17575093Mazzone 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.
- Background: PubMed 26860344Ando 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.
- Background: PubMed 25467586Abdulqawi 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.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Mazzone, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine Triphosphate, Capsaicin and Functional Brain Imaging in people with Cough, run by Stuart Mazzone at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brainstem Neural Activations to Capsaicin (time frame: fMRI was performed in a single session on the day of the cough challenge testing session and not more than seven days after.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722849, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.