A Trial Assessing LAS34273 in 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#947
- Almirall Investigational Sites#645
- Almirall Investigational Sites#646
- Almirall Investigational Sites#644
- Almirall Investigational Sites#647
- Almirall Investigational Sites#649
- Almirall Investigational Sites#110
- Almirall Investigational Sites#394
- Almirall Investigational Sites#651
- Almirall Investigational Sites#393
- Almirall Investigational Sites#658
- Almirall Investigational Sites#653
- Almirall Investigational Sites#654
- Almirall Investigational Sites#656
- Almirall Investigational Sites#652
- Almirall Investigational Sites#657
- Almirall Investigational Sites#972
- Almirall Investigational Sites#971
- Almirall Investigational Sites#655
- Almirall Investigational Sites#953
- Almirall Investigational Sites#664
- Almirall Investigational Sites#660
- Almirall Investigational Sites#662
- Almirall Investigational Sites#666
- Almirall Investigational Sites#661
- Almirall Investigational Sites#665
- Almirall Investigational Sites#659
- Almirall Investigational Sites#954
- Almirall Investigational Sites#398
- Almirall Investigational Sites#397
- Almirall Investigational Sites#390
- Almirall Investigational Sites#594
- Almirall Investigational Sites#593
- Almirall Investigational Sites#750
- Almirall Investigational Sites#669
- Almirall Investigational Sites#672
- Almirall Investigational Sites#948
- Almirall Investigational Sites#549
- Almirall Investigational Sites#671
- Almirall Investigational Sites#752
- Almirall Investigational Sites#678
- Almirall Investigational Sites#677
- Almirall Investigational Sites#758
- Almirall Investigational Sites#765
- Almirall Investigational Sites#680
- Almirall Investigational Sites#681
- Almirall Investigational Sites#191
- Almirall Investigational Sites#766
- Almirall Investigational Sites#757
- Almirall Investigational Sites#675
- Almirall Investigational Sites#684
- Almirall Investigational Sites#687
- Almirall Investigational Sites#683
- Almirall Investigational Sites#688
- Almirall Investigational Sites#686
- Almirall Investigational Sites#689
- Almirall Investigational Sites#682
- Almirall Investigational Sites#685
- Almirall Investigational Sites#459
- Almirall Investigational Sites#774
- Almirall Investigational Sites#286
- Almirall Investigational Sites#694
- Almirall Investigational Sites#635
- Almirall Investigational Sites#777
- Almirall Investigational Sites#346
- Almirall Investigational Sites#551
- Almirall Investigational Sites#348
- Almirall Investigational Sites#695
- Almirall Investigational Sites#700
- Almirall Investigational Sites#698
- Almirall Investigational Sites#697
- Almirall Investigational Sites#699
- Almirall Investigational Sites#696
- Almirall Investigational Sites#702
- Almirall Investigational Sites#706
- Almirall Investigational Sites#705
- Almirall Investigational Sites#701
- Almirall Investigational Sites#962
- Almirall Investigational Sites#714
- Almirall Investigational Sites#970
- Almirall Investigational Sites#713
- Almirall Investigational Sites#712
- Almirall Investigational Sites#961
- Almirall Investigational Sites#709
- Almirall Investigational Sites#711
- Almirall Investigational Sites#715
- Almirall Investigational Sites#717
- Almirall Investigational Sites#462
- Almirall Investigational Sites#977
- Almirall Investigational Sites#721
- Almirall Investigational Sites#540
- Almirall Investigational Sites#967
- Almirall Investigational Sites#716
- Almirall Investigational Sites#722
- Almirall Investigational Sites#719
- Almirall Investigational Sites#582
- Almirall Investigational Sites#785
- Almirall Investigational Sites#976
- Almirall Investigational Sites#588
- Almirall Investigational Sites#720
- Almirall Investigational Sites#965
- Almirall Investigational Sites#969
- Almirall Investigational Sites#543
- Almirall Investigational Sites#787
- Almirall Investigational Sites#975
- Almirall Investigational Sites#465
- Almirall Investigational Sites#966
- Almirall Investigational Sites#972
- Almirall Investigational Sites#786
- Almirall Investigational Sites#963
- Almirall Investigational Sites#718
- Almirall Investigational Sites#16
- Almirall Investigational Sites#7
- Almirall Investigational Sites#317
- Almirall Investigational Sites#61
- Almirall Investigational Sites#938
- Almirall Investigational Sites#727
- Almirall Investigational Sites#723
- Almirall Investigational Sites#725
- Almirall Investigational Sites#738
- Almirall Investigational Sites#42
- Almirall Investigational Sites#734
- Almirall Investigational Sites#735
- Almirall Investigational Sites#788
- Almirall Investigational Sites#737
- Almirall Investigational Sites#784
- Almirall Investigational Sites#37
- Almirall Investigational Sites#730
- Almirall Investigational Sites#731
- Almirall Investigational Sites#728
- Almirall Investigational Sites#732
- Almirall Investigational Sites#736
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 once-daily via inhalation
Outcomes
Primary Outcome Measures
Trough FEV1 (L) at 28 Weeks on Treatment
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks
Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment
Trough FEV1 (mean of two highest FEV1 values assessed 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
NCT00363896
Brief Title
A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 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
843 (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 once-daily via inhalation
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
Aclidinium bromide 200 μg once-daily via inhalation via 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 of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks
Time Frame
Week 28
Title
Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment
Description
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks
Time Frame
Week 12
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
Week 52
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:
Facility Name
Almirall Investigational Sites#947
City
Escaldes
Country
Andorra
Facility Name
Almirall Investigational Sites#645
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Almirall Investigational Sites#646
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Almirall Investigational Sites#644
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Almirall Investigational Sites#647
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Almirall Investigational Sites#649
City
Wien
ZIP/Postal Code
1145
Country
Austria
Facility Name
Almirall Investigational Sites#110
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Almirall Investigational Sites#394
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Almirall Investigational Sites#651
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Almirall Investigational Sites#393
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Almirall Investigational Sites#658
City
Burgas
ZIP/Postal Code
800
Country
Bulgaria
Facility Name
Almirall Investigational Sites#653
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Almirall Investigational Sites#654
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Almirall Investigational Sites#656
City
Russe
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Almirall Investigational Sites#652
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Almirall Investigational Sites#657
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Almirall Investigational Sites#972
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Almirall Investigational Sites#971
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Almirall Investigational Sites#655
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Almirall Investigational Sites#953
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Almirall Investigational Sites#664
City
Lovosice
ZIP/Postal Code
410 02
Country
Czech Republic
Facility Name
Almirall Investigational Sites#660
City
Neratovice
ZIP/Postal Code
277 11
Country
Czech Republic
Facility Name
Almirall Investigational Sites#662
City
Plzen
ZIP/Postal Code
324 01
Country
Czech Republic
Facility Name
Almirall Investigational Sites#666
City
Prague
ZIP/Postal Code
169 02
Country
Czech Republic
Facility Name
Almirall Investigational Sites#661
City
Praha
ZIP/Postal Code
182 00
Country
Czech Republic
Facility Name
Almirall Investigational Sites#665
City
Tabor
ZIP/Postal Code
390 03
Country
Czech Republic
Facility Name
Almirall Investigational Sites#659
City
Tremosna
ZIP/Postal Code
330 11
Country
Czech Republic
Facility Name
Almirall Investigational Sites#954
City
Zatec
ZIP/Postal Code
43801
Country
Czech Republic
Facility Name
Almirall Investigational Sites#398
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Almirall Investigational Sites#397
City
Odense C.
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Almirall Investigational Sites#390
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Almirall Investigational Sites#594
City
Beuvry
ZIP/Postal Code
62660
Country
France
Facility Name
Almirall Investigational Sites#593
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Almirall Investigational Sites#750
City
Grasse
ZIP/Postal Code
06130
Country
France
Facility Name
Almirall Investigational Sites#669
City
Montpellier,cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Almirall Investigational Sites#672
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Almirall Investigational Sites#948
City
Perpignan Cedex
ZIP/Postal Code
66025
Country
France
Facility Name
Almirall Investigational Sites#549
City
Rouen , Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Almirall Investigational Sites#671
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Almirall Investigational Sites#752
City
Vieux Conde
ZIP/Postal Code
59690
Country
France
Facility Name
Almirall Investigational Sites#678
City
Bad Wörishofen
ZIP/Postal Code
86825
Country
Germany
Facility Name
Almirall Investigational Sites#677
City
Berlin-Spandau
ZIP/Postal Code
13597
Country
Germany
Facility Name
Almirall Investigational Sites#758
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
Almirall Investigational Sites#765
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Almirall Investigational Sites#680
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Almirall Investigational Sites#681
City
Bonn
ZIP/Postal Code
53123
Country
Germany
Facility Name
Almirall Investigational Sites#191
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Almirall Investigational Sites#766
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Almirall Investigational Sites#757
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Almirall Investigational Sites#675
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Almirall Investigational Sites#684
City
Budapest
ZIP/Postal Code
1117
Country
Hungary
Facility Name
Almirall Investigational Sites#687
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Almirall Investigational Sites#683
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Almirall Investigational Sites#688
City
Nyiregyhaza
ZIP/Postal Code
4412
Country
Hungary
Facility Name
Almirall Investigational Sites#686
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Almirall Investigational Sites#689
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Almirall Investigational Sites#682
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Almirall Investigational Sites#685
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Almirall Investigational Sites#459
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Almirall Investigational Sites#774
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Almirall Investigational Sites#286
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Almirall Investigational Sites#694
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Almirall Investigational Sites#635
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Almirall Investigational Sites#777
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Almirall Investigational Sites#346
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Almirall Investigational Sites#551
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Almirall Investigational Sites#348
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Almirall Investigational Sites#695
City
Hoofddorp
ZIP/Postal Code
2134TM
Country
Netherlands
Facility Name
Almirall Investigational Sites#700
City
Lodz
ZIP/Postal Code
90-430
Country
Poland
Facility Name
Almirall Investigational Sites#698
City
Lodz
ZIP/Postal Code
91-520
Country
Poland
Facility Name
Almirall Investigational Sites#697
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Almirall Investigational Sites#699
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Almirall Investigational Sites#696
City
Warszawa
ZIP/Postal Code
01-337
Country
Poland
Facility Name
Almirall Investigational Sites#702
City
Warszawa
ZIP/Postal Code
03-416
Country
Poland
Facility Name
Almirall Investigational Sites#706
City
Wroclaw
ZIP/Postal Code
50-434
Country
Poland
Facility Name
Almirall Investigational Sites#705
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Almirall Investigational Sites#701
City
Zawadzkie
ZIP/Postal Code
47-120
Country
Poland
Facility Name
Almirall Investigational Sites#962
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Almirall Investigational Sites#714
City
Bucharest
ZIP/Postal Code
21659
Country
Romania
Facility Name
Almirall Investigational Sites#970
City
Bucuresti
ZIP/Postal Code
0100825
Country
Romania
Facility Name
Almirall Investigational Sites#713
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
Almirall Investigational Sites#712
City
Iasi
ZIP/Postal Code
700115
Country
Romania
Facility Name
Almirall Investigational Sites#961
City
Judetul Brasov
ZIP/Postal Code
500365
Country
Romania
Facility Name
Almirall Investigational Sites#709
City
Palazu Mare
ZIP/Postal Code
900002
Country
Romania
Facility Name
Almirall Investigational Sites#711
City
Targu Mures
ZIP/Postal Code
540139
Country
Romania
Facility Name
Almirall Investigational Sites#715
City
Timisoara
ZIP/Postal Code
1900
Country
Romania
Facility Name
Almirall Investigational Sites#717
City
Moscow region
ZIP/Postal Code
143405
Country
Russian Federation
Facility Name
Almirall Investigational Sites#462
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Almirall Investigational Sites#977
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Almirall Investigational Sites#721
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Almirall Investigational Sites#540
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Almirall Investigational Sites#967
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Almirall Investigational Sites#716
City
Moscow
ZIP/Postal Code
117485
Country
Russian Federation
Facility Name
Almirall Investigational Sites#722
City
Moscow
ZIP/Postal Code
119048
Country
Russian Federation
Facility Name
Almirall Investigational Sites#719
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Almirall Investigational Sites#582
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Almirall Investigational Sites#785
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Almirall Investigational Sites#976
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Almirall Investigational Sites#588
City
Saint Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Facility Name
Almirall Investigational Sites#720
City
Saint Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Almirall Investigational Sites#965
City
Saint Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Almirall Investigational Sites#969
City
saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Almirall Investigational Sites#543
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Almirall Investigational Sites#787
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Almirall Investigational Sites#975
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Almirall Investigational Sites#465
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Almirall Investigational Sites#966
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Almirall Investigational Sites#972
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Almirall Investigational Sites#786
City
Saint Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Almirall Investigational Sites#963
City
Saint Petersburg
ZIP/Postal Code
198216
Country
Russian Federation
Facility Name
Almirall Investigational Sites#718
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Almirall Investigational Sites#16
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Almirall Investigational Sites#7
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Almirall Investigational Sites#317
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Almirall Investigational Sites#61
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Almirall Investigational Sites#938
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Almirall Investigational Sites#727
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Almirall Investigational Sites#723
City
San Juan de Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Almirall Investigational Sites#725
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Almirall Investigational Sites#738
City
Bedford
ZIP/Postal Code
MK42 9DJ
Country
United Kingdom
Facility Name
Almirall Investigational Sites#42
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Almirall Investigational Sites#734
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Almirall Investigational Sites#735
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Almirall Investigational Sites#788
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Almirall Investigational Sites#737
City
Hereford
ZIP/Postal Code
HR1 2ER
Country
United Kingdom
Facility Name
Almirall Investigational Sites#784
City
London
ZIP/Postal Code
E2 9JX
Country
United Kingdom
Facility Name
Almirall Investigational Sites#37
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Almirall Investigational Sites#730
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Almirall Investigational Sites#731
City
Peterborough
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
Almirall Investigational Sites#728
City
Solihull
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
Almirall Investigational Sites#732
City
Suffolk
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Almirall Investigational Sites#736
City
Windsor
ZIP/Postal Code
SL4 3DP
Country
United Kingdom
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
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4056&filename=Synopsis_m-34273-30.pdf
Description
CSR Synopsis
Learn more about this trial
A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
We'll reach out to this number within 24 hrs