Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000850279
Ethics application status
Not yet submitted
Date submitted
28/09/2009
Date registered
1/10/2009
Date last updated
1/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined corticosteroid and long-acting beta-agonist versus corticosteroid for moderate/severe chronic obstructive pulmonary disease. A double blind, randomized, multicenter, phase III study.
Scientific title
In adults with Chronic Obstructive Pulmonary Disease (COPD), is corticosteroid combined with long-acting beta-agonist effective in forced expiratory volume in one second (FEV1) values, as compared to corticosteroid?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD (Chronic obstructive pulmonary disease) 251920 0
Condition category
Condition code
Respiratory 252098 252098 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two arms:
1)Fluticasone 500 micrograms +Formoterol 12 micrograms, twice a day, for 12 weeks; capsule for inhalation
2)Fluticasone 500 micrograms, twice a day, for 12 weeks; capsule for inhalation
Intervention code [1] 241340 0
Treatment: Drugs
Comparator / control treatment
Fluticasone 500 micrograms, twice a day, for 12 weeks; capsule for inhalation
Control group
Active

Outcomes
Primary outcome [1] 252981 0
forced expiratory volume in one second
(FEV1) measures (comparing randomization visit and last visit)
test: spirometry
Timepoint [1] 252981 0
screening visit, randomization visit and last visit (12 week)
Secondary outcome [1] 257743 0
forced vital capacity (FVC) measures (comparing randomization visit and last visit)
test: spirometry
Timepoint [1] 257743 0
screening visit, randomization visit and last visit (12 week)
Secondary outcome [2] 257744 0
rescue medication (utilization) -Short acting Beta-agonist
Timepoint [2] 257744 0
all visits, except for the screening visit (diary card)
Frequency of visits: Baseline and once monthly for 12 weeks.
Secondary outcome [3] 257745 0
peak flow variation using a peak flow meter
Timepoint [3] 257745 0
All visits, except for the screening visit
Frequency of visits: Baseline and once monthly for 12 weeks.

Eligibility
Key inclusion criteria
moderate or severe COPD according to GOLD (Global Initiative for Chronic Obstructive Lung Disease)

smoker or former smoker
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hospitalization due to COPD up to 4 weeks before screening visit

Subjects who have required treatment with oral corticosteroids, anti-leukotriene, immunoglobulins, beta-blockers, digitalis, itraconazole 2 months prior to Visit 1

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
136
Accrual to date
Final
Recruitment outside Australia
Country [1] 2157 0
Brazil
State/province [1] 2157 0

Funding & Sponsors
Funding source category [1] 243794 0
Commercial sector/Industry
Name [1] 243794 0
Ache Laboratories
Country [1] 243794 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Aché Laboratories
Address
Rodovia Dutra km 222,2
Guarulhos, State of Sao Paulo
Brazil
CEP (ZIP) 07034-904
Country
Brazil
Secondary sponsor category [1] 237148 0
None
Name [1] 237148 0
N/A
Address [1] 237148 0
N/A
Country [1] 237148 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243923 0
Ethics committee address [1] 243923 0
Ethics committee country [1] 243923 0
Date submitted for ethics approval [1] 243923 0
15/06/2009
Approval date [1] 243923 0
Ethics approval number [1] 243923 0

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

Contacts
Principal investigator
Name 30327 0
Address 30327 0
Country 30327 0
Phone 30327 0
Fax 30327 0
Email 30327 0
Contact person for public queries
Name 13574 0
Fabio Ikedo
Address 13574 0
Rodovia Dutra km 222,2
CEP 07034-904
Guarulhos
Sao Paulo
Brazil
Country 13574 0
Brazil
Phone 13574 0
55-11-26088181
Fax 13574 0
Email 13574 0
fabio.ikedo@ache.com.br
Contact person for scientific queries
Name 4502 0
Fabio Ikedo
Address 4502 0
Rodovia Dutra km 222,2
CEP 07034-904
Guarulhos
Sao Paulo
Brazil
Country 4502 0
Brazil
Phone 4502 0
55-11-26088181
Fax 4502 0
Email 4502 0
fabio.ikedo@ache.com.br

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.