Chronic CoughNCT00858624
Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
A study testing ketamine in people with Chronic Cough, run by Jacky Smith at 1 site in United Kingdom.
Trial summary
A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. Chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. Current treatment is often ineffective in these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Cough
- What is being tested?
- ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers:
- Over 18 years old
- Measurable cough reflex sensitivity
- No current or past history of chronic cough or chronic respiratory disease.
- No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip.
- Chronic Cough Patients
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- Over 18 years old
- Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease.
- Normal CXR
- Normal lung function
- Measurable cough reflex sensitivity
Who cannot join
- Recent Upper Respiratory Tract Infection (4 weeks)
- Pregnancy/breast feeding
- Current smokers or ex-smokers with < 6 months abstinence or cumulative history of > 10 packyears
- Diabetes Mellitus
- Opiate or ACE Inhibitor use.
- Any centrally acting medication which has the potential to alter cough reflex sensitivity.
Show all 9Show fewer
- Significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness.
- Drug or alcohol abuse
- History of allergy or reaction to ketamine of other NMDA receptor antagonists.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Manchester, Education and Research Centre, Wythenshawe Hospital
Manchester, Manchester, M23 9LT
About this study
A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. Chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. Current treatment is often ineffective in these patients. To develop new medications the investigators need to understand more about the mechanisms that can lead to excessive coughing.
This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic cough. The investigators hypothesise that that chronic cough patients have a more sensitive cough reflex as a result central nervous system hyper-excitability (central sensitisation). The investigators will measure cough reflex sensitivity before and after administration of ketamine, a medication that blocks an important receptor in the central nervous system.
- Conditions
- Chronic Cough
- Being tested
- ketamine
- Keywords
- Cough, Cough reflex, NMDA receptor, central sensitisation
- Medical subject headings
- Chronic Cough, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
Administration of low dose intravenous ketamine. Dose: 0.075mg/kg over 10 minutes followed by 0.005mg/kg/min over 20 minutes. Given as single infusion.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Cough Patients | Active comparator | Not described Receives: Drug: ketamine |
| Healthy Volunteers | Active comparator | Not described Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough Reflex Sensitivity
Measured: 6 months
Secondary outcomes (3)
Upper Oesophageal Pain Thresholds
Measured: 6 months
Pain Thresholds Pharynx
Measured: 6 months
Pain Thresholds Chest Wall
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacky Smith
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacky Smith, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858624
- Sponsor's protocol ID
- 07/H1004/142
- Status last verified
- Jun 2013
- First submitted
- 9 Mar 2009
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
- ClinicalTrials.gov ID
- NCT00858624
- Acronym / sponsor ID
- 07/H1004/142
- Conditions
- Chronic Cough
- Keywords
- Cough, Cough reflex, NMDA receptor, central sensitisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jacky SmithUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. Chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. Current treatment is often ineffective in these patients. To develop new medications the investigators need to understand more about the mechanisms that can lead to excessive coughing.
This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic cough. The investigators hypothesise that that chronic cough patients have a more sensitive cough reflex as a result central nervous system hyper-excitability (central sensitisation). The investigators will measure cough reflex sensitivity before and after administration of ketamine, a medication that blocks an important receptor in the central nervous system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Cough Patients | Active comparator | Drug: ketamine |
| Healthy Volunteers | Active comparator | Drug: ketamine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Over 18 years old
- Measurable cough reflex sensitivity
- No current or past history of chronic cough or chronic respiratory disease.
- No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip.
- Chronic Cough Patients
Key exclusion criteria (9 listed)
- Recent Upper Respiratory Tract Infection (4 weeks)
- Pregnancy/breast feeding
- Current smokers or ex-smokers with < 6 months abstinence or cumulative history of > 10 packyears
- Diabetes Mellitus
- Opiate or ACE Inhibitor use.
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 |
|---|---|---|
| ketamineAdministration of low dose intravenous ketamine. Dose: 0.075mg/kg over 10 minutes followed by 0.005mg/kg/min over 20 minutes. Given as single infusion. | Drug | Chronic Cough Patients, Healthy Volunteers |
Primary outcome
Cough Reflex Sensitivity
Time frame: 6 months
3 secondary outcomes
Upper Oesophageal Pain Thresholds
Time frame: 6 months
Pain Thresholds Pharynx
Time frame: 6 months
Pain Thresholds Chest Wall
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine in people with Chronic Cough, run by Jacky Smith at 1 site in United Kingdom.
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 11 inclusion and 9 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 19 Jun 2013. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cough Reflex Sensitivity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2013.