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ClUDo: The Clinical Utility of Capsaicin Dose Response Curves to Discriminate Cough Hyper-responsiveness

The Clinical Utility of Capsaicin Dose Response Curves to Discriminate Cough Hyper-responsiveness

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN23684347
Enrollment
200
Registered
2014-01-23
Start date
2013-08-04
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic cough Respiratory Chronic cough

Interventions

96 chronic cough patients and 96 healthy volunteers are recruited to this study. In attempt to establish normal reference ranges, the healthy volunteers will be evenly recruited by ag

Sponsors

University Hospital of South Manchester NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteers: 1. Male and female aged over 18 years 2. Normal spirometry 3. No current or past history of chronic cough or respiratory disease 4. No current chronic pain, irritable bowel syndrome, psychiatric illness or chronic headaches Chronic cough patients: 1. Male and female aged over 18 years 2. Diagnosis of chronic cough (defined as cough lasting more than 8 weeks) 3. Normal spirometry 4. Normal chest x-ray

Exclusion criteria

Exclusion criteria: 1. Current smoker or ex-smoker with >20 pack year history, and >6 months abstinence 2. Upper respiratory tract infection within last 4 weeks 3. Use of angiotensin-converting-enzyme (ACE) inhibitors 4. Use of any centrally acting medications which may alter the cough reflex* 5. History of drug or alcohol abuse 6. Pregnancy or breastfeeding 7. Concomitant conditions which may alter cough reflex sensitivity e.g. diabetes mellitus, Parkinson?s disease, cerebrovascular disease.

Design outcomes

Primary

MeasureTime frame
Emax (maximum number of coughs provoked) and ED50 (capsaicin dose provoking half the Emax) will be measured to discriminate between male and female chronic cough patients and healthy controls to test the usefulness of the procedure as a clinical test. Measured at baseline only.

Secondary

MeasureTime frame
Emax, ED50, cough severity visual analogue scales (VAS) and objective cough frequency will also be used to assess differences in male and female healthy volunteers and chronic cough patients. Measured at baseline only.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026