Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/05/2008
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

Prof Ashley Woodcock

ORCID ID

Contact details

North West Lung Centre
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5873
ashley.woodcock@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226093097

Study information

Scientific title

Acronym

Study hypothesis

1. To validate cough programme in the clinical setting (both in hospital and in the home environment)
2. To determine the specificity and sensitivity of the technique
3. To develop the programme further using more advanced sound analysis to improve detection and recognition of cough
4. To test the programme's ability to detect the effect of codeine linctus

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

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Codeine phosphate 60 mg or matched placebo were given, in random order, at the start of each cough recording (0 and 12 hours).

Intervention type

Drug

Phase

Not Specified

Drug names

Codeine

Primary outcome measures

The number of coughs in each group before and after codeine, both in hospital and at home.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2002

Overall trial end date

31/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

21 patients with physician-diagnosed, stable disease who complained of cough.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

21

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2002

Recruitment end date

31/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West Lung Centre
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Charity

Funder name

North West Lung Centre Charity (UK)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16630941

Publication citations

  1. Results

    Smith J, Owen E, Earis J, Woodcock A, Effect of codeine on objective measurement of cough in chronic obstructive pulmonary disease., J. Allergy Clin. Immunol., 2006, 117, 4, 831-835, doi: 10.1016/j.jaci.2005.09.055.

Additional files

Editorial Notes