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CompletedNCT00977366NOTCHUpdated Jun 19, 2013

Neurophysiology of Cough Reflex Hypersensitivity

An interventional study of Hydrochloric acid (0.15 molar) and Saline in Cough and Healthy Controls, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-19.

Sponsored by University of Manchester · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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:

  1. Can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications?
  2. 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.

02

Conditions studied

  • Cough
  • Healthy Controls

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03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 27 is below the median of 70 across 263 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    Hydrochloric acid infusion

    Other: Hydrochloric acid (0.15 molar)

  • Placebo comparator
    Saline

    Other: Saline

Interventions

  • OtherHydrochloric acid (0.15 molar)

    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.

  • OtherSaline

    Normal saline will be infused in to the lower oesophagus through a distal infusion port located at the tip of an oesophageal stimulation catheter.

06

What researchers measure

Primary outcomes

  1. Effect of oesophageal acid infusion on cough reflex sensitivity in chronic cough patients compared to healthy controls.

    Outcome measures include; cough reflex sensitivity, pain threshold measures, 24 hour objective cough rate

    Time frame: baseline, immediatley after infusion, 90 minutes post infusion, 180 minutes post infusion, 24 hours after baseline

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Study locations

1 site
  • University Hospital of South Manchester
    Manchester, M23 9LT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00977366
Lead sponsor
University of Manchester
Collaborators
JP Moulton Charitable Foundation, Medical Research Council
Responsible party
Jacky Smith (MRC Clinician Scientist/Honorary Respiratory Consultant, University of Manchester) — Principal investigator
First posted
Sep 15, 2009
Start date
Mar 2010
Primary completion
Sep 2012
Completion
Feb 2013
Last update
Jun 19, 2013

Study contacts

Ashley Woodcock, Prof
principal investigator · The University of Manchester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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