Novel Endpoints in Cough Challenge Testing (NEAT)

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Asthma
Cough
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014