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Novel Endpoints in Cough Challenge Testing (NEAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566968
First Posted: March 30, 2012
Last Update Posted: April 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust
  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 Manchester University 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566968


Locations
United Kingdom
University Hospital of South Manchester
Manchester, Greater Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Manchester University 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

Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01566968     History of Changes
Other Study ID Numbers: NEAT Version 2, 18/03/11
First Submitted: January 24, 2012
First Posted: March 30, 2012
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Manchester University NHS Foundation Trust:
COPD
Asthma
Healthy volunteers
Chronic cough
Smokers
Cough challenge
Cough challenge testing.

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cough
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms