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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00358436




Registration number
NCT00358436
Ethics application status
Date submitted
28/07/2006
Date registered
31/07/2006
Date last updated
4/01/2017

Titles & IDs
Public title
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
Scientific title
Secondary ID [1] 0 0
ACCLAIM II
Secondary ID [2] 0 0
M/34273/31
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aclidinium bromide
Treatment: Drugs - Placebo

Experimental: Aclidinium 200 µg once-daily - Aclidinium bromide 200 µg once-daily by inhalation

Placebo comparator: Placebo - Placebo by inhalation


Treatment: Drugs: Aclidinium bromide
Aclidinium bromide 200 µg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

Treatment: Drugs: Placebo
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trough FEV1 (L) at 28 Weeks on Treatment
Timepoint [1] 0 0
28 weeks
Primary outcome [2] 0 0
Trough FEV1 (L) at 12 Weeks on Treatment
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
Timepoint [2] 0 0
52 weeks

Eligibility
Key inclusion criteria
* Males and females aged = 40 years with a clinical diagnosis of moderate to severe stable COPD
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle 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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
804
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Almirall Investigational Sites#807 - Adelaide
Recruitment hospital [2] 0 0
Almirall Investigational Sites#834 - Auchenflower
Recruitment hospital [3] 0 0
Almirall Investigational Sites#808 - Bankstown
Recruitment hospital [4] 0 0
Almirall Investigational Sites#806 - Boxhill
Recruitment hospital [5] 0 0
Almirall Investigational Sites#814 - Cairns
Recruitment hospital [6] 0 0
Almirall Investigational Sites#813 - Camperdown
Recruitment hospital [7] 0 0
Almirall Investigational Sites#811 - Carina Heights
Recruitment hospital [8] 0 0
Almirall Investigational Sites#803 - Clayton
Recruitment hospital [9] 0 0
Almirall Investigational Sites#809 - Kippa Ring
Recruitment hospital [10] 0 0
Almirall Investigational Sites#8121 - Nedlands
Recruitment hospital [11] 0 0
Almirall Investigational Sites#812 - Nedlands
Recruitment hospital [12] 0 0
Almirall Investigational Sites#805 - Toorak Gardens
Recruitment hospital [13] 0 0
Almirall Investigational Sites#815 - Woodville
Recruitment postcode(s) [1] 0 0
5061 - Adelaide
Recruitment postcode(s) [2] 0 0
2031 - Auchenflower
Recruitment postcode(s) [3] 0 0
2200 - Bankstown
Recruitment postcode(s) [4] 0 0
3128 - Boxhill
Recruitment postcode(s) [5] 0 0
4870 - Cairns
Recruitment postcode(s) [6] 0 0
2050 - Camperdown
Recruitment postcode(s) [7] 0 0
4152 - Carina Heights
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment postcode(s) [11] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [12] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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New Jersey
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New Mexico
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North Carolina
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Ohio
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Texas
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Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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El Palomar
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Argentina
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Vicente López
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Canada
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Edmonton
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Canada
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Kelowna
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Montreal
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Niagara Falls
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Canada
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Ottawa
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Canada
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Toronto, Ontario
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Mexico
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Monterrey
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Mexico
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Zapopan
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New Zealand
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Auckland
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New Zealand
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Grafton
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New Zealand
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Tauranga
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South Africa
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Amanzimtoti
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South Africa
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Bloemfontain
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South Africa
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Bloemfontein
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Cape Town
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Durban
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South Africa
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Johannesburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Esther Garcia, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00358436