Condition category
Respiratory
Date applied
16/03/2011
Date assigned
07/04/2011
Last edited
14/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Young

ORCID ID

Contact details

North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
emma.young@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2.0

Study information

Scientific title

Comparing Capsaicin Dose-Response Curves

Acronym

DRC

Study hypothesis

The shape of capsaicin dose-response curves differ:
1. In healthy volunteers, asthmatics and patients with chronic cough
2. In men and women
These differences may provide insights into important mechanisms that lead to excessive coughing.

Ethics approval

North West 7 Research Ethics Committee - Greater Manchester Central approved 19/10/2010

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Chronic cough

Intervention

Two capsaicin cough challenge tests performed:
1. Increasing doses are inhaled up to maximum tolerated dose
2. Doses are inhaled in a random order
3. Number of coughs and urge-to-cough intensity recorded

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Comparison of maximum cough responses between patient groups

Secondary outcome measures

1. Comparison of cough threshold between patient groups
2. Comparison of urge-to-cough threshold between patient groups
3. Comparison of maximum cough responses and cough threshold in men and women

Overall trial start date

01/11/2009

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers
1. Over 18 years old
2. Normal lung function
3. No current or past history of chronic cough or chronic respiratory illness
4. No current or past history of chronic pain, irritable bowel syndrome or chronic headaches
5. No current or past history of psychiatric illness

Asthmatics
1. Over 18 years old
2. Physician diagnosis of asthma
3. Objective evidence of bronchial hyper-reactivity (either positive bronchial provocation test or significant (>12%) reversibility in FEV1 following inhaled bronchodilator)
4. Stable asthma [forced expiratory volume in one second (FEV1) > 75% predicted, no acute exacerbations requiring oral corticosteroids within last 4 weeks]
5. Can safely omit long-acting bronchodilators (if taking)

Chronic Cough Patients
1. Over 18 years old
2. Chronic cough, defined as a cough lasting longer than 8 weeks despite investigation and/or treatment trials for cough variant asthma, post-nasal drip and gastro-oesophageal reflux disease
3. Normal chest x-ray
4. Normal lung function
5. Can safely omit long-acting bronchodilators (if taking)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

All participants:
1. Recent upper respiratory tract infection (< 4weeks)
2. Pregnancy or breast-feeding
3. Use of agiotensin converting enzyme (ACE) inhibitors
4. Any centrally acting medication which could alter the sensitivity of the cough reflex
5. History of drug or alcohol abuse
6. Current smoker or ex-smoker with > 10 pack year smoking history

Recruitment start date

01/11/2009

Recruitment end date

31/07/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West Lung Research Centre
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospitals South Manchester NHS Trust (UK)

Sponsor details

c/o Andrew Maines
Research and Development
Education and Research Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
andrew.maines@manchester.ac.uk

Sponsor type

Not defined

Website

Funders

Funder type

Research council

Funder name

Medical Resarch Council (MRC) (UK) (ref: G0900449)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes