Novel Endpoints in Cough Challenge Testing

Completed

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

• Registration Number: NCT01566968
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-30
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD	Cough challenge test	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.
Healthy Volunteers	Cough challenge test	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.
Healthy Volunteers	24 hour ambulatory cough recording	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.
Healthy Volunteers	Cough quality of life questionnaire	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.
Asthma	Cough challenge test	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).
Asthma	24 hour ambulatory cough recording	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).
Asthma	Cough quality of life questionnaire	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).
COPD	24 hour ambulatory cough recording	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.
COPD	Cough quality of life questionnaire	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.
Healthy smokers	Cough challenge test	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.
Healthy smokers	24 hour ambulatory cough recording	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.
Healthy smokers	Cough quality of life questionnaire	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.
Chronic cough	Cough challenge test	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).
Chronic cough	24 hour ambulatory cough recording	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).
Chronic cough	Cough quality of life questionnaire	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).

Trial Locations

Locations (1)

University Hospital of South Manchester; 🇬🇧 Manchester, Greater Manchester, United Kingdom