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Trial registered on ANZCTR


Registration number
ACTRN12615000492550
Ethics application status
Approved
Date submitted
7/05/2015
Date registered
19/05/2015
Date last updated
28/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety of Tiotropium Prescription in Chronic Obstructive Pulmonary Disease (COPD): A survey in patients taking Tiotropium at the time of an admission to hospital with an Acute Exacerbation of COPD.
Scientific title
In patients with COPD, what are the patterns of use of Tiotropium at the time of an admission to hospital.
Secondary ID [1] 286661 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 294995 0
Condition category
Condition code
Respiratory 295260 295260 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Eligible participants with Chronic Obstructive Pulmonary Disease (COPD) will be given questionnaire(s) to complete relating to the specific medications that they are prescribed. Each participant will complete a questionnaire relating to Tiotropium use. Tiotropium is a Long-Acting Muscarinic Antagonist (LAMA) inhaler used in patients with COPD. It should not be co-prescribed with Short-Acting Muscarinic Antagonists (such as Ipratropium) due to unwanted side-effects and cardiovascular risks. If participants are prescribed concomitant ipratropium-containing medications they will receive an additional questionnaire for each of these medications. The duration of observation in each participant will be as long as is required for the participant to fill out the questionnaire(s), and is anticipated to take no longer than thirty minutes.
Intervention code [1] 291805 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295008 0
Proportion of patients who used more than one actuation of Tiotropium per day on any of the seven days prior to this admission, as asked by a questionnaire developed specifically for the purposes of this study.
Timepoint [1] 295008 0
Assessed upon recruitment (at some stage during the participant's admission) but regarding Tiotropium use in the 7 days prior to admission.
Secondary outcome [1] 314570 0
Maximum use of Tiotropium in a 24-hour period in the 7 days prior to this admission, as asked by questionnaire developed specifically for the purposes of this study.
Timepoint [1] 314570 0
Assessed upon recruitment (at some stage during the participant's admission) but regarding Tiotropium use in the 7 days prior to admission.
Secondary outcome [2] 314571 0
Proportion of patients who are co-prescribed Tiotropium and Ipratropium (either regularly in the community or acutely during this admission), as asked by questionnaire developed specifically for the purposes of this study and reviewed on patient records.
Timepoint [2] 314571 0
Assessed upon recruitment (at some stage during the participant's admission) and regarding Tiotropium use in the 6 months prior to admission, and including this admission.
Secondary outcome [3] 314572 0
Proportion of patients who use more than their prescribed Tiotropium dose routinely (defined by using more than 1 puff per day at least once per week), as asked by questionnaire developed specifically for the purposes of this study.
Timepoint [3] 314572 0
Assessed at the time of admission but regarding Tiotropium use in the last 6 months prior to admission.
Secondary outcome [4] 314573 0
Proportion of patients prescribed Tiotropium with co-existing cardiovascular disease as documented in patient medical records.
Timepoint [4] 314573 0
At the time of admission
Secondary outcome [5] 314574 0
Proportion of patients prescribed Tiotropium with co-existing moderate to severe renal impairment as documented in medical records or from laboratory results.
Timepoint [5] 314574 0
At the time of admission

Eligibility
Key inclusion criteria
i. Admitted to hospital with an AECOPD.

ii. Prescribed Tiotropium at the time of admission.

iii. Greater than or equal to 40 years of age on admission
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Patients unwilling to complete the questionnaire(s).

ii. Patients in whom Tiotropium has been commenced during this admission.

iii. Patients who do not have the capacity to give full written informed consent to participate in the study (as judged by the investigator).

Study design
Purpose
Duration
Selection
Timing
Both
Statistical methods / analysis
The primary characteristic of interest is the proportion of patients who used more than one actuation of Tiotropium per day in the seven days prior to admission.
A sample size of 100 gives a 95% CI for a proportion plus or minus 10%. E.g. sample size of 100 has 90% power to rule out a proportion of 25% if the true proportion is 38%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/05/2015
Actual
21/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6866 0
New Zealand
State/province [1] 6866 0
Wellington

Funding & Sponsors
Funding source category [1] 291236 0
Charities/Societies/Foundations
Name [1] 291236 0
Medical Research Institute of New Zealand
Country [1] 291236 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 289911 0
None
Name [1] 289911 0
Address [1] 289911 0
Country [1] 289911 0
Other collaborator category [1] 278462 0
Individual
Name [1] 278462 0
Dr George Bardsley
Address [1] 278462 0
MRINZ
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country [1] 278462 0
New Zealand
Other collaborator category [2] 278463 0
Individual
Name [2] 278463 0
Dr Janine Pilcher
Address [2] 278463 0
MRINZ
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country [2] 278463 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292795 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 292795 0
Ethics committee country [1] 292795 0
New Zealand
Date submitted for ethics approval [1] 292795 0
Approval date [1] 292795 0
20/03/2015
Ethics approval number [1] 292795 0
15/NTB/35

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

Contacts
Principal investigator
Name 57070 0
Prof Richard Beasley
Address 57070 0
MRINZ
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country 57070 0
New Zealand
Phone 57070 0
+64 4 805 0147
Fax 57070 0
Email 57070 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 57071 0
George Bardsley
Address 57071 0
MRINZ
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country 57071 0
New Zealand
Phone 57071 0
+64 4 805 0147
Fax 57071 0
Email 57071 0
george.bardsley@mrinz.ac.nz
Contact person for scientific queries
Name 57072 0
George Bardsley
Address 57072 0
MRINZ
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country 57072 0
New Zealand
Phone 57072 0
+64 4 805 0147
Fax 57072 0
Email 57072 0
george.bardsley@mrinz.ac.nz

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.