Acoustic analysis of the effect of codeine on cough in asthma and chronic obstructive pulmonary disease

ISRCTN ISRCTN57615270
DOI https://doi.org/10.1186/ISRCTN57615270
Protocol serial number N0226093097
Sponsor Department of Health (UK)
Funder North West Lung Centre Charity (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
12/05/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ashley Woodcock
Scientific

North West Lung Centre
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone +44 (0)161 291 5873
Email ashley.woodcock@manchester.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease (COPD)
InterventionCodeine phosphate 60 mg or matched placebo were given, in random order, at the start of each cough recording (0 and 12 hours).
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Codeine
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/05/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration21
Key inclusion criteria21 patients with physician-diagnosed, stable disease who complained of cough.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2002
Date of final enrolment31/05/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

North West Lung Centre
Manchester
M23 9LT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/04/2006 Yes No