N/A
N=58
Functional Magnetic Resonance Imaging of ATP Cough in Chronic Cough Patients
Cough
Bottom Line
View on ClinicalTrials.gov: NCT03722849 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Brainstem Neural Activations to Capsaicin — 0.09; 0.39; -0.14; 0.44 Percentage change in BOLD signal — p==0.0028
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adenosine Triphosphate (Drug); Capsaicin (Drug); Functional Brain Imaging (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stuart Mazzone
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brainstem Neural Activations to Capsaicin |
0.09; 0.39; -0.14; 0.44 | =0.0028 sig |
| PRIMARY Brainstem Neural Activations to ATP |
0.04; 0.28; 0.01; 0.58 | =0.0070 sig |
| SECONDARY Behavioral Responses During Cough Challenge Testing: Cough Sensitivity to Capsaicin |
0.91; 2.00; 3.80; 12.89; 0.91; 3.02 | =0.0019 sig |
| SECONDARY Behavioral Responses During Cough Challenge Testing: Cough Sensitivity to ATP |
1.29; 2.75; 5.75; 57.54; 2.82; 19.95 | — |
| SECONDARY Behavioral Responses to Cough Challenge Testing: Urge to Cough Ratings to Capsaicin and ATP |
2.07; 1.61; 4.48; 6.80; 2.31; 1.80 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with physician diagnosed chronic refractory cough (cough lasting >8 weeks).
- > 18 years of age
- Must be cognitively impaired
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).
Data sourced from ClinicalTrials.gov (NCT03722849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.