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

January 24, 2012
April 5, 2012
January 2011
April 2012   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01566968 on ClinicalTrials.gov Archive Site
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Novel Endpoints in Cough Challenge Testing
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Selected from secondary care.

  • Chronic Obstructive Pulmonary Disease
  • Asthma
  • Healthy
  • Chronic Cough
  • Smokers
  • 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 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.
    Interventions:
    • 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).
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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).
    Interventions:
    • Other: Cough challenge test
    • Other: 24 hour ambulatory cough recording
    • Other: Cough quality of life questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01566968
NEAT Version 2, 18/03/11
No
University Hospital of South Manchester NHS Foundation Trust
University Hospital of South Manchester NHS Foundation Trust
Not Provided
Principal Investigator: Saifudin Khalid, MRCP University Hospital of South Manchester
Study Chair: Ashley Woodcock, MD University Hospital of South Manchester
University Hospital of South Manchester NHS Foundation Trust
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP