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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
Timepoint [1] 0 0
28 weeks
Primary outcome [2] 0 0
Trough FEV1 (L) at 12 Weeks on Treatment - Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment - Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.
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 - Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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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Oregon
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South Carolina
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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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Canada
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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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Tauranga
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South Africa
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Amanzimtoti
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Bloemfontain
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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
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with
moderate to severe COPD during one year of treatment.
Trial website
https://clinicaltrials.gov/show/NCT00358436
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

Summary results
Other publications