Chronic Obstructive Pulmonary DiseaseNEATNCT01566968
Novel Endpoints in Cough Challenge Testing
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The sensitivity of a person's cough reflex can be measured by getting them to breathe in (inhale) irritant chemicals. There are different methods by which subjects are asked to inhale these chemicals, either by taking one deep breath in, or by asking them to just continue to take a number of breaths. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma, Healthy
- What is being tested?
- Cough challenge test, 24 hour ambulatory cough recording and Cough quality of life questionnaire
- How many people
- 98 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Apr 2012
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Selected from secondary care.
Who may be able to join
- Adult subjects aged 18 and over.
- Meet criteria for subject groups as outlined below:
- Healthy volunteers:
- Must be non smokers.
- No history of respiratory disease.
- Healthy smokers:
Show all 21Show fewer
- Current smokers with at least 10 pack year history of smoking.
- Spirometry within normal limits i.e. FEV1 > 80% predicted and FEV1/FVC ratio of > 75% predicted.
- Asthma:
- Physician diagnosis of asthma
- Stable asthma.
- Airway hyperresponsiveness to methacoline; PC20< 16mg/ml.
- Non smokers or ex-smokers with smoking history of less than 10 pack years.
- COPD:
- Physician diagnosis of COPD
- Ex smokers with smoking history of at least 20 pack years
- Spirometry demonstating evidence of airflow obstruction i.e. FEV1/FVC ratio of < 70%
- Chronic cough:
- History of dry cough for at least 8 weeks.
- Normal chest x ray.
- Non smokers or ex smokers of less than 10 pack years history of smoking.
Who cannot join
- Symptoms of upper respiratory tract infection within the last 4 weeks.
- Participation in another clinical trial of an investigational drug within 4 weeks.
- Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate.
- Patients with severe respiratory disease i.e. FEV1 < 1.0 litre.
- Use of steroid tablets in previous 2 months or taken more than 3 courses of steroid tablets in the preceding 12 months in subjects with asthma or COPD.
- Change in asthma treatment in the preceding 6 weeks in asthma group
- Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of South Manchester
Manchester, Greater Manchester, M23 9LT
About this study
Official title: Novel Endpoints in Cough Challenge Testing.
The sensitivity of a person's cough reflex can be measured by getting them to breathe in (inhale) irritant chemicals. There are different methods by which subjects are asked to inhale these chemicals, either by taking one deep breath in, or by asking them to just continue to take a number of breaths. The purpose of this clinical research study is to see if the coughing responses are different in healthy people and people with respiratory problems that make them cough when they are given these chemicals in these two methods.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Healthy, Chronic Cough, Smokers
- Being tested
- Cough challenge test, 24 hour ambulatory cough recording, Cough quality of life questionnaire
- Keywords
- COPD, Asthma, Healthy volunteers, Chronic cough, Smokers, Cough challenge, Cough challenge testing.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough challenge testOther
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
24 hour ambulatory cough recordingOther
Cough recording by using an ambulatory sound recording device.
Cough quality of life questionnaireOther
questionnaire designed to assess impact of cough on a person's life
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Adults between ages of 18-75 inclusive who have never smoked and have no history of any respiratory disease for which they are on regular treatment. Receives: Other: Cough challenge test; Other: 24 hour ambulatory cough recording; Other: Cough quality of life questionnaire | |
| Asthma | Adults between the ages on 18-75 inclusive who have a physician diagnosis of asthma and have no smoking history or minimal smoking history (less than 10 pack years or in other words less than 20 cigarettes per day for 10 years). Receives: Other: Cough challenge test; Other: 24 hour ambulatory cough recording; Other: Cough quality of life questionnaire | |
| COPD | Adults between the ages of 18-75 inclusive who have previously been smokers (at least 20 pack years) and have physician diagnosis and spirometry evidence of COPD. Receives: Other: Cough challenge test; Other: 24 hour ambulatory cough recording; Other: Cough quality of life questionnaire | |
| Healthy smokers | Adults between the ages of 18-75 inclusive who are currently smokers (at least 10 pack years history)but have no history of any respiratory disease and no evidence of COPD on spirometry. Receives: Other: Cough challenge test; Other: 24 hour ambulatory cough recording; Other: Cough quality of life questionnaire | |
| Chronic cough | Adults between ages of 18-75 inclusive who have history of dry cough for at least 8 weeks and have a normal chest x ray and no smoking history or minimal smoking history (less than 10 pack years). Receives: Other: Cough challenge test; Other: 24 hour ambulatory cough recording; Other: Cough quality of life questionnaire |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Saifudin Khalid, MRCP, Principal investigator, University Hospital of South ManchesterAshley Woodcock, MD, Study chair, University Hospital of South Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566968
- Sponsor's protocol ID
- NEAT Version 2, 18/03/11
- Acronym
- NEAT
- Status last verified
- Apr 2012
- First submitted
- 24 Jan 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Endpoints in Cough Challenge Testing.
- ClinicalTrials.gov ID
- NCT01566968
- Acronym / sponsor ID
- NEAT / NEAT Version 2, 18/03/11
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Healthy, Chronic Cough, Smokers
- Keywords
- COPD, Asthma, Healthy volunteers, Chronic cough, Smokers, Cough challenge, Cough challenge testing.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Mar 2012 (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.
The sensitivity of a person's cough reflex can be measured by getting them to breathe in (inhale) irritant chemicals. There are different methods by which subjects are asked to inhale these chemicals, either by taking one deep breath in, or by asking them to just continue to take a number of breaths. The purpose of this clinical research study is to see if the coughing responses are different in healthy people and people with respiratory problems that make them cough when they are given these chemicals in these two methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Cough challenge test, Other: 24 hour ambulatory cough recording, Other: Cough quality of life questionnaireAdults between ages of 18-75 inclusive who have never smoked and have no history of any respiratory disease for which they are on regular treatment. |
| Asthma | – | Other: Cough challenge test, Other: 24 hour ambulatory cough recording, Other: Cough quality of life questionnaireAdults between the ages on 18-75 inclusive who have a physician diagnosis of asthma and have no smoking history or minimal smoking history (less than 10 pack years or in other words less than 20 cigarettes per day for 10 years). |
| COPD | – | Other: Cough challenge test, Other: 24 hour ambulatory cough recording, Other: Cough quality of life questionnaireAdults between the ages of 18-75 inclusive who have previously been smokers (at least 20 pack years) and have physician diagnosis and spirometry evidence of COPD. |
| Healthy smokers | – | Other: Cough challenge test, Other: 24 hour ambulatory cough recording, Other: Cough quality of life questionnaireAdults between the ages of 18-75 inclusive who are currently smokers (at least 10 pack years history)but have no history of any respiratory disease and no evidence of COPD on spirometry. |
| Chronic cough | – | Other: Cough challenge test, Other: 24 hour ambulatory cough recording, Other: Cough quality of life questionnaireAdults between ages of 18-75 inclusive who have history of dry cough for at least 8 weeks and have a normal chest x ray and no smoking history or minimal smoking history (less than 10 pack years). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Selected from secondary care.
Key inclusion criteria (21 listed)
- Adult subjects aged 18 and over.
- Must be non smokers.
- No history of respiratory disease.
- Current smokers with at least 10 pack year history of smoking.
- Spirometry within normal limits i.e. FEV1 > 80% predicted and FEV1/FVC ratio of > 75% predicted.
Key exclusion criteria (7 listed)
- Symptoms of upper respiratory tract infection within the last 4 weeks.
- Participation in another clinical trial of an investigational drug within 4 weeks.
- Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate.
- Patients with severe respiratory disease i.e. FEV1 < 1.0 litre.
- Use of steroid tablets in previous 2 months or taken more than 3 courses of steroid tablets in the preceding 12 months in subjects with asthma or COPD.
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 |
|---|---|---|
| Cough challenge testCough challenge will be performed with Capsaicin, citric acid and prostaglandin E2. | Other | Asthma, COPD, Chronic cough, Healthy Volunteers, Healthy smokers |
| 24 hour ambulatory cough recordingCough recording by using an ambulatory sound recording device. | Other | Asthma, COPD, Chronic cough, Healthy Volunteers, Healthy smokers |
| Cough quality of life questionnairequestionnaire designed to assess impact of cough on a person's life | Other | Asthma, COPD, Chronic cough, Healthy Volunteers, Healthy smokers |
Primary outcome
Not reported in the source record.
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 6 Apr 2012.
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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.
Saifudin Khalid, MRCP principal investigator
University Hospital of South Manchester
Ashley Woodcock, MD study chair
University Hospital of South Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Manchester University NHS Foundation Trust 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 21 inclusion and 7 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 6 Apr 2012. 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.
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 6 Apr 2012.