Novel Endpoints in Cough Challenge Testing

Healthy Clinical Trial

— NEAT  

Official title:

Novel Endpoints in Cough Challenge Testing.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566968
• Other study ID #: NEAT Version 2, 18/03/11
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: April 5, 2012
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: University Hospital of South Manchester NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Chronic Cough
• Chronic Obstructive Pulmonary Disease
• Cough
• Healthy
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Smokers

Intervention

Other:
• Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
• 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
• Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life

Locations

Country	Name	City	State
United Kingdom	University Hospital of South Manchester	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of South Manchester NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,