Condition category
Respiratory
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
16/02/2015
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 Jaclyn Smith

ORCID ID

Contact details

University Hospital of South Manchester NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5879
jacky.smith@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226187456

Study information

Scientific title

A study to investigate the effects of voluntary coughing on the airways of asthmatic and COPD subjects

Acronym

Study hypothesis

To determine the effects of short bursts of voluntary coughing on airway physiology and lung function in asthmatic and COPD subjects.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Respiratory: Chronic obstructive pulmonary disease (COPD)

Intervention

Subjects will be randomised to either progressively increasing periods of voluntary coughing or no intervention, both interspersed with measurements of lung function.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The fall in exhaled nitric oxide (eNO) following voluntary coughing.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

30/10/2006

Overall trial end date

30/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18
2. Physician diagnosed asthma or COPD

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10 stable mild asthmatic, 10 stable COPD subjects

Participant exclusion criteria

1. Symptoms of upper respiratory tract infection or asthmatic/COPD exacerbation in the preceding 4 weeks
2. Involved in studies with licensed drugs or methodological studies within the preceding 4 weeks
3. Subjects taking ACE inhibitors, leukotrine receptor antagonists or cough suppressants
4. Change in asthma/COPD medication in last 4 weeks
5. Pregnancy
6. Current smokers

Recruitment start date

30/10/2006

Recruitment end date

30/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of South Manchester NHS Foundation Trust
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)207 307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of South Manchester NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NWLC Endowment Funds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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