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Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With 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 / Formoterol Fumarate
Salmeterol / Fluticasone
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult male or non-pregnant, non-lactating female aged ≥40.
  • Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
  • Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post-bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visits
  • Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and Randomisation Visits
  • Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visits
  • Patients eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained

Exclusion Criteria:

  • History or current diagnosis of asthma
  • Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit or during the run-in period
  • Clinically significant respiratory conditions
  • Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
  • Patients who, in the investigator's opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit
  • Use of long-term oxygen therapy (≥15 hours/day)
  • Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks prior to the Screening Visit
  • Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
  • Clinically significant cardiovascular conditions
  • Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters or in the physical examination at the Screening Visit
  • Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
  • Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
  • Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
  • History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
  • Patient with any other serious or uncontrolled physical or mental dysfunction
  • Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
  • Patient unlikely to be cooperative or that can't comply with the study procedures
  • Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening Visit
  • Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication
  • Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study

Sites / Locations

  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
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  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
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  • Almirall Investigational Site
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  • Almirall Investigational Site
  • Almirall Investigational Site
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  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
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  • Almirall Investigational Site
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  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
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  • Almirall Investigational Site
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  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
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  • Almirall Investigational Site
  • Almirall Investigational Site
  • Almirall Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aclidinium Bromide / Formoterol Fumarate

Salmeterol / Fluticasone propionate

Arm Description

Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks

Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks

Outcomes

Primary Outcome Measures

Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration

Secondary Outcome Measures

Transition Dyspnoea Index (TDI) Focal Score at Week 24
The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 ("major deterioration") to zero ("no change") to +3 ("major improvement"). Category scores are added to compute the Focal Score (from -9 to 9)

Full Information

First Posted
July 23, 2013
Last Updated
February 8, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01908140
Brief Title
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
933 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aclidinium Bromide / Formoterol Fumarate
Arm Type
Experimental
Arm Description
Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
Arm Title
Salmeterol / Fluticasone propionate
Arm Type
Active Comparator
Arm Description
Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
Intervention Type
Drug
Intervention Name(s)
Aclidinium Bromide / Formoterol Fumarate
Intervention Type
Drug
Intervention Name(s)
Salmeterol / Fluticasone
Other Intervention Name(s)
Seretide, Advair
Primary Outcome Measure Information:
Title
Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
Description
Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Transition Dyspnoea Index (TDI) Focal Score at Week 24
Description
The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 ("major deterioration") to zero ("no change") to +3 ("major improvement"). Category scores are added to compute the Focal Score (from -9 to 9)
Time Frame
At Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or non-pregnant, non-lactating female aged ≥40. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post-bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visits Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and Randomisation Visits Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visits Patients eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained Exclusion Criteria: History or current diagnosis of asthma Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit or during the run-in period Clinically significant respiratory conditions Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension Patients who, in the investigator's opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit Use of long-term oxygen therapy (≥15 hours/day) Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks prior to the Screening Visit Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers Clinically significant cardiovascular conditions Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters or in the physical examination at the Screening Visit Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm) Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer Patient with any other serious or uncontrolled physical or mental dysfunction Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment Patient unlikely to be cooperative or that can't comply with the study procedures Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening Visit Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Garcia, Ph.D.
Organizational Affiliation
Global Medicines Development
Official's Role
Study Director
Facility Information:
Facility Name
Almirall Investigational Site
City
Feldbach
ZIP/Postal Code
8330
Country
Austria
Facility Name
Almirall Investigational Site
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
Facility Name
Almirall Investigational Site
City
Grieskirchen
ZIP/Postal Code
A-4710
Country
Austria
Facility Name
Almirall Investigational Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Almirall Investigational Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Almirall Investigational Site
City
Dimitrovgrad
ZIP/Postal Code
6400
Country
Bulgaria
Facility Name
Almirall Investigational Site
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Almirall Investigational Site
City
Kozlodui
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
Almirall Investigational Site
City
Petrich
ZIP/Postal Code
2850
Country
Bulgaria
Facility Name
Almirall Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Almirall Investigational Site
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Facility Name
Almirall Investigational Site
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Almirall Investigational Site
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
Almirall Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
AB T6G 2B7
Country
Canada
Facility Name
Almirall Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
BC V5Z 1M9
Country
Canada
Facility Name
Almirall Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
BC V7M 2H9
Country
Canada
Facility Name
Almirall Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
NB E1C 5K4
Country
Canada
Facility Name
Almirall Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
ON M6H 3M2
Country
Canada
Facility Name
Almirall Investigational Site
City
Saint Romuald
State/Province
Quebec
ZIP/Postal Code
QC G6W 5M6
Country
Canada
Facility Name
Almirall Investigational Site
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
QC G8T 7A1
Country
Canada
Facility Name
Almirall Investigational Site
City
Karlovy Vary
ZIP/Postal Code
360 09
Country
Czech Republic
Facility Name
Almirall Investigational Site
City
Kralupy nad Vltavou
ZIP/Postal Code
278 01
Country
Czech Republic
Facility Name
Almirall Investigational Site
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
Facility Name
Almirall Investigational Site
City
Ostrava - Hrabuvka
ZIP/Postal Code
700 30
Country
Czech Republic
Facility Name
Almirall Investigational Site
City
Rokycany
ZIP/Postal Code
337 01
Country
Czech Republic
Facility Name
Almirall Investigational Site
City
Strakonice
ZIP/Postal Code
386 01
Country
Czech Republic
Facility Name
Almirall Investigational Site
City
Nîmes
ZIP/Postal Code
30900
Country
France
Facility Name
Almirall Investigational Site
City
Perpignan
ZIP/Postal Code
66025
Country
France
Facility Name
Almirall Investigational Site
City
Vieux Conde
ZIP/Postal Code
59690
Country
France
Facility Name
Almirall Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Almirall Investigational Site
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Almirall Investigational Site
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
Almirall Investigational Site
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Almirall Investigational Site
City
Berlin
ZIP/Postal Code
12043
Country
Germany
Facility Name
Almirall Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Almirall Investigational Site
City
Berlin
ZIP/Postal Code
13581
Country
Germany
Facility Name
Almirall Investigational Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Almirall Investigational Site
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Almirall Investigational Site
City
Bonn
ZIP/Postal Code
53123
Country
Germany
Facility Name
Almirall Investigational Site
City
Cologne
ZIP/Postal Code
51069
Country
Germany
Facility Name
Almirall Investigational Site
City
Cottbus
ZIP/Postal Code
03050
Country
Germany
Facility Name
Almirall Investigational Site
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
Facility Name
Almirall Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Almirall Investigational Site
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Almirall Investigational Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Almirall Investigational Site
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Almirall Investigational Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Almirall Investigational Site
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Almirall Investigational Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Almirall Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Almirall Investigational Site
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Almirall Investigational Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Almirall Investigational Site
City
Leipzig
ZIP/Postal Code
4357
Country
Germany
Facility Name
Almirall Investigational Site
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Almirall Investigational Site
City
Munich
ZIP/Postal Code
80539
Country
Germany
Facility Name
Almirall Investigational Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Almirall Investigational Site
City
Schwabach
ZIP/Postal Code
91126
Country
Germany
Facility Name
Almirall Investigational Site
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Almirall Investigational Site
City
Wiesloch
ZIP/Postal Code
69168
Country
Germany
Facility Name
Almirall Investigational Site
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Almirall Investigational Site
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Almirall Investigational Site
City
Budapest
ZIP/Postal Code
1191
Country
Hungary
Facility Name
Almirall Investigational Site
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Almirall Investigational Site
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Almirall Investigational Site
City
Komárom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Almirall Investigational Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Almirall Investigational Site
City
Pécs
ZIP/Postal Code
H-7635
Country
Hungary
Facility Name
Almirall Investigational Site
City
Szazhalombatta
ZIP/Postal Code
H-2400
Country
Hungary
Facility Name
Almirall Investigational Site
City
Szigetszentmiklós
ZIP/Postal Code
H-2310
Country
Hungary
Facility Name
Almirall Investigational Site
City
Vásárosnamény
ZIP/Postal Code
4800
Country
Hungary
Facility Name
Almirall Investigational Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Almirall Investigational Site
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Almirall Investigational Site
City
Trieste
ZIP/Postal Code
34149
Country
Italy
Facility Name
Almirall Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Almirall Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92231
Country
Lithuania
Facility Name
Almirall Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Almirall Investigational Site
City
Vilnius
ZIP/Postal Code
LT-01117
Country
Lithuania
Facility Name
Almirall Investigational Site
City
Almere
ZIP/Postal Code
1311 RL
Country
Netherlands
Facility Name
Almirall Investigational Site
City
Beek
ZIP/Postal Code
6191 JW
Country
Netherlands
Facility Name
Almirall Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Almirall Investigational Site
City
Hoofddorp
ZIP/Postal Code
2134
Country
Netherlands
Facility Name
Almirall Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Almirall Investigational Site
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Almirall Investigational Site
City
Bialystok
ZIP/Postal Code
15-010
Country
Poland
Facility Name
Almirall Investigational Site
City
Bialystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Almirall Investigational Site
City
Bialystok
ZIP/Postal Code
15-270
Country
Poland
Facility Name
Almirall Investigational Site
City
Gdansk
ZIP/Postal Code
80-847
Country
Poland
Facility Name
Almirall Investigational Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Almirall Investigational Site
City
Krakow
ZIP/Postal Code
31-455
Country
Poland
Facility Name
Almirall Investigational Site
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Almirall Investigational Site
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Almirall Investigational Site
City
Pila
ZIP/Postal Code
64-920
Country
Poland
Facility Name
Almirall Investigational Site
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Almirall Investigational Site
City
Proszowice
ZIP/Postal Code
32-100
Country
Poland
Facility Name
Almirall Investigational Site
City
Sopot
ZIP/Postal Code
81-741
Country
Poland
Facility Name
Almirall Investigational Site
City
Szczecin
ZIP/Postal Code
71-124
Country
Poland
Facility Name
Almirall Investigational Site
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Almirall Investigational Site
City
Tczew
ZIP/Postal Code
83-110
Country
Poland
Facility Name
Almirall Investigational Site
City
Warsaw
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Almirall Investigational Site
City
Wilkowice-Bystra
ZIP/Postal Code
43-365
Country
Poland
Facility Name
Almirall Investigational Site
City
Belville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Almirall Investigational Site
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Almirall Investigational Site
City
Gauteng
ZIP/Postal Code
158
Country
South Africa
Facility Name
Almirall Investigational Site
City
Gauteng
ZIP/Postal Code
1724
Country
South Africa
Facility Name
Almirall Investigational Site
City
Middelburg
ZIP/Postal Code
1050
Country
South Africa
Facility Name
Almirall Investigational Site
City
Pretoria
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Almirall Investigational Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Almirall Investigational Site
City
Alicante
ZIP/Postal Code
03114
Country
Spain
Facility Name
Almirall Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Almirall Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Almirall Investigational Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Almirall Investigational Site
City
Elda
ZIP/Postal Code
03600
Country
Spain
Facility Name
Almirall Investigational Site
City
Laredo
ZIP/Postal Code
39770
Country
Spain
Facility Name
Almirall Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Almirall Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
Almirall Investigational Site
City
Sant Boi de Llobregat
ZIP/Postal Code
08830
Country
Spain
Facility Name
Almirall Investigational Site
City
Santander
ZIP/Postal Code
38008
Country
Spain
Facility Name
Almirall Investigational Site
City
Seville
ZIP/Postal Code
41071
Country
Spain
Facility Name
Almirall Investigational Site
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Almirall Investigational Site
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Almirall Investigational Site
City
Glasgow
ZIP/Postal Code
G20 0SP
Country
United Kingdom
Facility Name
Almirall Investigational Site
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Almirall Investigational Site
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
Almirall Investigational Site
City
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Almirall Investigational Site
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Almirall Investigational Site
City
Sidcup
ZIP/Postal Code
DA14 6LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27492833
Citation
Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M, Kirsten AM, Beier J, Seoane B, Segarra RM, Leselbaum A. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016 Oct;48(4):1030-1039. doi: 10.1183/13993003.00216-2016. Epub 2016 Aug 4.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3947&filename=LAC39_CSR_Synopsis.pdf
Description
CSR Synopsis

Learn more about this trial

Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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