Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000148673
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
15/08/2005
Date last updated
15/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Beta-blockers and Airways Disease
Scientific title
A prospective observational study of cardiology patients to estimate the prevalence of coexistant obstructive airways disease using spirometry, to document cardiologists' current prescribing practices with regard to beta-blocker medications and to measure both short and long term adverse beta-blocker effects in terms of spirometry, respiratory symptoms, exacerbation rates and hospital admissions.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive airways disease - COPD 238 0
Asthma 239 0
Condition category
Condition code
Respiratory 269 269 0 0
Chronic obstructive pulmonary disease
Respiratory 270 270 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study intervention comprised an interviewer-administered questionnaire and measurement of spirometry. Specifically at time of enrolment, prior to hospital discharge, at 6 months and 12 months respiratory symptoms, measures of spirometry and bronchodilator response (using Salbutamol 5mg and Ipratropium bromide 0.5 mg combined via a nebuliser for assessment of bronchodilator response), exacerbation rates and hospital admission rates were recorded.
Intervention code [1] 154 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 320 0
Estimation of prevalence of obstructive airways disease amongst the study population
Timepoint [1] 320 0
At time of enrolment, prior to hospital discharge, at 6 months and 12 months
Secondary outcome [1] 712 0
Define cardiologists' prescription practices with regard to beta-blocker medications in patients with obstructive airways disease.
Timepoint [1] 712 0
Measurements recorded at time of hospital admission and hospital discharge.
Secondary outcome [2] 713 0
Assess for adverse repsiratory effects of beta-blocker use, over a year's duration, in terms of presence/severity of respiratory symptoms, exacerbations rates, hospital admissions and spirometry performance.
Timepoint [2] 713 0
Timing of measurements as defined above under interventions, except for exacerations and hospital admission rates which were assessed at enrolment, at 6 months and at 12 months.

Eligibility
Key inclusion criteria
Acceptance for hospital admission under the cardiology unit of Royal Pince Alfred Hospital for assessment and treatment of an acute cardiac condition
Minimum age
Not stated
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 326 0
Self funded/Unfunded
Name [1] 326 0
Country [1] 326 0
Primary sponsor type
Individual
Name
Belinda Cochrane
Address
Country
Secondary sponsor category [1] 257 0
None
Name [1] 257 0
nil
Address [1] 257 0
Country [1] 257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1248 0
Royal Prince Alfred Hospital (Central Sydney Area Health Service Ethics Committee)
Ethics committee address [1] 1248 0
Ethics committee country [1] 1248 0
Australia
Date submitted for ethics approval [1] 1248 0
Approval date [1] 1248 0
Ethics approval number [1] 1248 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35895 0
Address 35895 0
Country 35895 0
Phone 35895 0
Fax 35895 0
Email 35895 0
Contact person for public queries
Name 9343 0
Belinda Cochrane
Address 9343 0
1/10 Gow St.
Balmain NSW 2041
Country 9343 0
Australia
Phone 9343 0
+61 403969332
Fax 9343 0
Email 9343 0
[email protected]
Contact person for scientific queries
Name 271 0
Belinda Cochrane
Address 271 0
1/10 Gow St.
Balmain NSW 2041
Country 271 0
Australia
Phone 271 0
+61 403969332
Fax 271 0
Email 271 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.