Novel Endpoints in Cough Challenge Testing (NEAT)

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Chronic Obstructive Pulmonary Disease; Asthma; Chronic Cough; Smokers
• Intervention / Treatment: Other: Cough challenge test; Other: 24 hour ambulatory cough recording; Other: Cough quality of life questionnaire

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M23 9LT
      • University Hospital of South Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Selected from secondary care.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 30, 2012

Study Record Updates

• Last Update Posted (Estimate): April 6, 2012
• Last Update Submitted That Met QC Criteria: April 5, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Healthy volunteers; Asthma; COPD; Smokers; Chronic cough; Cough challenge; Cough challenge testing.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cough
• Other Study ID Numbers: NEAT Version 2, 18/03/11