Back to resultsEfficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium bromide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Lung function, Exacerbations, Quality of Life
Eligibility Criteria
Inclusion Criteria: Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD 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
Sites / Locations
- Almirall Investigational Sites#926
- Almirall Investigational Sites#858
- Almirall Investigational Sites#900
- Almirall Investigational Sites#899
- Almirall Investigational Sites#855
- Almirall Investigational Sites#879
- Almirall Investigational Sites#932
- Almirall Investigational Sites#904
- Almirall Investigational Sites#903
- Almirall Investigational Sites#930
- Almirall Investigational Sites#922
- Almirall Investigational Sites#893
- Almirall Investigational Sites#871
- Almirall Investigational Sites#902
- Almirall Investigational Sites#850
- Almirall Investigational Sites#897
- Almirall Investigational Sites#924
- Almirall Investigational Sites#882
- Almirall Investigational Sites#895
- Almirall Investigational Sites#880
- Almirall Investigational Sites#888
- Almirall Investigational Sites#952
- Almirall Investigational Sites#844
- Almirall Investigational Sites#863
- Almirall Investigational Sites#152
- Almirall Investigational Sites#8533
- Almirall Investigational Sites#920
- Almirall Investigational Sites#894
- Almirall Investigational Sites#889
- Almirall Investigational Sites#890
- Almirall Investigational Sites#907
- Almirall Investigational Sites#931
- Almirall Investigational Sites#849
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- Almirall Investigational Sites#872
- Almirall Investigational Sites#892
- Almirall Investigational Sites#864
- Almirall Investigational Sites#876
- Almirall Investigational Sites#923
- Almirall Investigational Sites#866
- Almirall Investigational Sites#911
- Almirall Investigational Sites#883
- Almirall Investigational Sites#976
- Almirall Investigational Sites#843
- Almirall Investigational Sites#868
- Almirall Investigational Sites#884
- Almirall Investigational Sites#916
- Almirall Investigational Sites#906
- Almirall Investigational Sites#909
- Almirall Investigational Sites#846
- Almirall Investigational Sites#885
- Almirall Investigational Sites#921
- Almirall Investigational Sites#896
- Almirall Investigational Sites#861
- Almirall Investigational Sites#919
- Almirall Investigational Sites#878
- Almirall Investigational Sites#842
- Almirall Investigational Sites#915
- Almirall Investigational Sites#848
- Almirall Investigational Sites#870
- Almirall Investigational Sites#847
- Almirall Investigational Sites#928
- Almirall Investigational Sites#905
- Almirall Investigational Sites#860
- Almirall Investigational Sites#886
- Almirall Investigational Sites#910
- Almirall Investigational Sites#918
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- Almirall Investigational Sites#813
- Almirall Investigational Sites#811
- Almirall Investigational Sites#803
- Almirall Investigational Sites#809
- Almirall Investigational Sites#8121
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- Almirall Investigational Sites#823
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- Almirall Investigational Sites#826
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aclidinium 200 μg once-daily
Placebo
Arm Description
Aclidinium bromide 200 μg once-daily by inhalation
Placebo by inhalation
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00358436
Brief Title
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Lung function, Exacerbations, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
804 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aclidinium 200 μg once-daily
Arm Type
Experimental
Arm Description
Aclidinium bromide 200 μg once-daily by inhalation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo by inhalation
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
Primary Outcome Measure Information:
Title
Trough FEV1 (L) at 28 Weeks on Treatment
Description
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
Time Frame
28 weeks
Title
Trough FEV1 (L) at 12 Weeks on Treatment
Description
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
Description
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.
Time Frame
52 weeks
Title
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
Description
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
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Garcia, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Jasper
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City
Zapopan
ZIP/Postal Code
452000
Country
Mexico
Facility Name
Almirall Investigational Sites#936
City
Auckland
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
Almirall Investigational Sites#830
City
Grafton
ZIP/Postal Code
1001
Country
New Zealand
Facility Name
Almirall Investigational Sites#832
City
Tauranga
ZIP/Postal Code
3140
Country
New Zealand
Facility Name
Almirall Investigational Sites#833
City
Amanzimtoti
ZIP/Postal Code
4125
Country
South Africa
Facility Name
Almirall Investigational Sites#836
City
Bloemfontain
ZIP/Postal Code
9317
Country
South Africa
Facility Name
Almirall Investigational Sites#841
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Almirall Investigational Sites#839
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Almirall Investigational Sites#835
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Almirall Investigational Sites#837
City
Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Almirall Investigational Sites#840
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Almirall Investigational Sites#834
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Almirall Investigational Sites#838
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
21518460
Citation
Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12(1):55. doi: 10.1186/1465-9921-12-55.
Results Reference
derived
Links:
URL
http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp
Description
Sponsor web site
URL
http://www.frx.com/
Description
Co-Sponsor web site
Learn more about this trial
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
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