Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000079347
Ethics application status
Approved
Date submitted
30/01/2008
Date registered
13/02/2008
Date last updated
13/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combination Therapy with Tiotropium in Chronic Obstructive Pulmonary Disease (COTTS)
Scientific title
Combination therapy with tiotropium and formoterol in moderate to severe Chronic Obstructive Pulmonary Disease: effects on exercise capacity and health related quality of life
Universal Trial Number (UTN)
Trial acronym
COTTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Airways Disease (COPD) 2778 0
Condition category
Condition code
Respiratory 2910 2910 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the initial visit all subjects will be commenced on Tiotropium 18mcg daily via inhaler. Subjects will be randomised to receive either placebo or formoterol 12mcg bd via inhaler for 6 weeks. There will then be a 2 week washout period for formoterol (not Tiotropium). Subjects will then crossover to the alternate arm of therapy for a further 6 weeks.
Intervention code [1] 2518 0
Treatment: Drugs
Comparator / control treatment
Tiotropium 18mcg daily via inhaler with additional placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 3793 0
Exercise capacity and health related quality of life as measured by the St George's Respiratory Questionnaire (SGRQ).
Timepoint [1] 3793 0
End of active and placebo phase.
Secondary outcome [1] 6400 0
Symptoms, spirometry and the Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Index.
Timepoint [1] 6400 0
End of active and placebo phase.

Eligibility
Key inclusion criteria
Chronic Obstructive Airways Disease (COPD).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Myocardial infarction within 3 months of enrolment in the study.
Prostatism
Glaucoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 775 0
New Zealand
State/province [1] 775 0

Funding & Sponsors
Funding source category [1] 3038 0
Charities/Societies/Foundations
Name [1] 3038 0
Auckland Medical Research Foundation
Country [1] 3038 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Centre for Clinical Research and effective practice (CCRep)
Address
Private Bag 93311
Otahuhu
Auckland
Country
New Zealand
Secondary sponsor category [1] 2739 0
None
Name [1] 2739 0
Address [1] 2739 0
Country [1] 2739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4992 0
Northern Y Ethics Committee
Ethics committee address [1] 4992 0
PO Box 1031
Hamilton
Ethics committee country [1] 4992 0
New Zealand
Date submitted for ethics approval [1] 4992 0
Approval date [1] 4992 0
16/03/2007
Ethics approval number [1] 4992 0
NTY/06/09/079

Summary
Brief summary
Tiotropium (Spiriva) and formoterol (Oxis) are both currently available prescription medicines for people with COPD. Each of them has a particular effect on the airway. They are usually prescribed independently although it is quite possible for them to be prescribed together. Therefore some people with COPD may already be taking one or both of them. People participating in this study will take a regular dose of tiotropium plus a placebo for 6 weeks and a regular dose of tiotropium plus formoterol for 6 weeks. There will be 2 weeks between each 6 week period when participants will take only tiotropium.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28341 0
Address 28341 0
Country 28341 0
Phone 28341 0
Fax 28341 0
Email 28341 0
Contact person for public queries
Name 11498 0
Andrew Nelson
Address 11498 0
CCRep
Private Bag 93311
Otahuhu
Auckland
Country 11498 0
New Zealand
Phone 11498 0
+64 9 276 0044 extn 2988
Fax 11498 0
+64 9 250 3878
Email 11498 0
[email protected]
Contact person for scientific queries
Name 2426 0
Lata Jayaram
Address 2426 0
Respiratory Department
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
Country 2426 0
New Zealand
Phone 2426 0
+64 9 276 0044 extn 2951
Fax 2426 0
Email 2426 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.