Trial record 5 of 772 for:
cough
Novel Endpoints in Cough Challenge Testing (NEAT)
This study has been completed.
Sponsor:
University Hospital of South Manchester NHS Foundation Trust
Information provided by (Responsible Party):
University Hospital of South Manchester NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01566968
First received: January 24, 2012
Last updated: April 5, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease Asthma Healthy Chronic Cough Smokers |
Other: Cough challenge test Other: 24 hour ambulatory cough recording Other: Cough quality of life questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Novel Endpoints in Cough Challenge Testing. |
Resource links provided by NLM:
Further study details as provided by University Hospital of South Manchester NHS Foundation Trust:
| Enrollment: | 98 |
| Study Start Date: | January 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
|
|
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).
|
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
|
|
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.
|
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
|
|
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.
|
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
|
|
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).
|
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Selected from secondary care.
Criteria
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566968
Locations
| United Kingdom | |
| University Hospital of South Manchester | |
| Manchester, Greater Manchester, United Kingdom, M23 9LT | |
Sponsors and Collaborators
University Hospital of South Manchester NHS Foundation Trust
Investigators
| Principal Investigator: | Saifudin Khalid, MRCP | University Hospital of South Manchester |
| Study Chair: | Ashley Woodcock, MD | University Hospital of South Manchester |
More Information
No publications provided
| Responsible Party: | University Hospital of South Manchester NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01566968 History of Changes |
| Other Study ID Numbers: | NEAT Version 2, 18/03/11 |
| Study First Received: | January 24, 2012 |
| Last Updated: | April 5, 2012 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University Hospital of South Manchester NHS Foundation Trust:
|
COPD Asthma Healthy volunteers Chronic cough |
Smokers Cough challenge Cough challenge testing. |
Additional relevant MeSH terms:
|
Cough Asthma Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases |
Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013