- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00977366
Neurophysiology of Cough Reflex Hypersensitivity (NOTCH)
Pilot Study Investigating Central Sensitisation of the Cough Reflex in Subjects With Chronic Cough and Healthy Volunteers
Central sensitisation is an increase in the excitability of nerves within the central nervous system, which can lead to heightened sensitivity to certain stimuli. This process is involved in some chronic pain conditions e.g. migraines and non-cardiac chest pain. Recent work by our group suggests central sensitisation may be an important mechanism leading to chronic cough.
The main questions in this study include:
- Can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications?
- Can the investigators demonstrate exaggerated sensitisation in patients with chronic cough (indicating these patients are already centrally sensitised)?
In animal studies, acid infusion into the gullet (oesophagus) is able to induce central sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain on the front of the chest but this study did not test the the cough reflex. Using human participants, the investigators plan to test whether acid infusion into the oesophagus increases the sensitivity of the cough reflex in healthy volunteers and also patients complaining of chronic cough.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Manchester, United Kingdom, M23 9LT
- University Hospital of South Manchester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy volunteers inclusion:
- Over 18 years
- Measurable cough reflex sensitivity - required as is the primary end-point
- No current or past history of chronic cough or chronic respiratory disease
Chronic Cough Patients inclusion:
- Over 18 years
- Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux
- Normal chest radiograph - primary respiratory cause for cough excluded
- Normal lung function - primary respiratory cause for cough excluded Measurable cough reflex sensitivity - required as primary end-point
Exclusion Criteria:
- Recent upper respiratory tract infection (<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles
- Pregnancy/breast-feeding - unknown effects of oesophageal acid infusion
- Current smokers or ex-smokers with < 6 month abstinence or history > 20 pack years - smoking can alter the sensitivity of the cough reflex
- Opiate or ACE inhibitor use or centrally acting medication - can alter the cough reflex sensitivity
- Symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity
- Significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Hydrochloric acid infusion
|
Hydrochloric acid (0.15 molar) will be infused in to the lower oesophagus through a distal infusion port located at the tip of an oesophageal stimulation catheter.
|
PLACEBO_COMPARATOR: Saline
|
Normal saline will be infused in to the lower oesophagus through a distal infusion port located at the tip of an oesophageal stimulation catheter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of oesophageal acid infusion on cough reflex sensitivity in chronic cough patients compared to healthy controls.
Time Frame: baseline, immediatley after infusion, 90 minutes post infusion, 180 minutes post infusion, 24 hours after baseline
|
Outcome measures include; cough reflex sensitivity, pain threshold measures, 24 hour objective cough rate
|
baseline, immediatley after infusion, 90 minutes post infusion, 180 minutes post infusion, 24 hours after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashley Woodcock, Prof, The University of Manchester
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/H1004/21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cough
-
Trevi TherapeuticsRecruitingRefractory Chronic CoughCanada, United Kingdom
-
Respivant Sciences GmbHRespivant Sciences Inc.TerminatedChronic Cough | IPF | Persistent Cough in IPFUnited States, United Kingdom, Netherlands, Australia, Belgium, New Zealand, Turkey, Italy, Germany, Czechia, Canada
-
The First Affiliated Hospital of Zhejiang Chinese...Completed
-
ILiAD BiotechnologiesCompletedPertussis/Whooping Cough | Bordetella Pertussis, Whooping CoughUnited Kingdom
-
KK Women's and Children's HospitalSingapore University of Technology and DesignUnknownCough | URTI | Cough Variant Asthma | Cough; Bronchial, With Grippe or InfluenzaSingapore
-
Shanghai Zhongshan HospitalNot yet recruitingSufentanil-induced Cough
-
Merck Sharp & Dohme LLCCompletedChronic CoughCanada, Czechia, Denmark, Hungary, Peru, Poland, Ukraine, United Kingdom, United States, Australia, China, Colombia, Germany, Guatemala, Israel, Italy, Malaysia, New Zealand, South Africa, Turkey
-
Khon Kaen UniversityCompleted
-
PhytoHealth CorporationCompleted
Clinical Trials on Hydrochloric acid (0.15 molar)
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University HospitalRecruitingCentral Line-associated Bloodstream Infection (CLABSI)Denmark
-
Instituto Universitario de Oftalmobiología Aplicada...EsteveRecruitingContact Lens ComplicationSpain
-
University of Sao PauloUnknown
-
Hospital Universitario Dr. Jose E. GonzalezRecruitingPromyelocytic LeukemiaMexico
-
Duke UniversityCephalonTerminatedMultiple MyelomaUnited States
-
Innovative MedicalCompleted
-
Universiti Kebangsaan Malaysia Medical CentreCompletedKetamine | MorphineMalaysia
-
National University of MalaysiaCompletedKetamine | MorphineMalaysia
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); CephalonTerminated
-
Laboratorios Sophia S.A de C.V.CompletedPhotorefractive Keratectomy | Corneal De-epithelializationMexico