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Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium bromide 200 μg bid
Aclidinium bromide 400 μg bid
Placebo
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) focused on measuring Chronic Obstructive Pulmonary Disease, antimuscarinic, COPD

Eligibility Criteria

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

Inclusion Criteria:

  • Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
  • Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
  • Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

  • Patients with no history or current diagnosis of asthma.
  • No evidence of an exacerbation within 6 weeks prior to the screening visit.
  • No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
  • No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Sites / Locations

  • Almirall Investigational Sites#4
  • Almirall Investigational Sites#9
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#2
  • Almirall Investigational Sites#1
  • Almirall Investigational Sites#11
  • Almirall Investigational Sites#6
  • Almirall Investigational Sites#12
  • Almirall Investigational Sites#7
  • Almirall Investigational Sites#10
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#1
  • Almirall Investigational Sites#2
  • Almirall Investigational Sites#6
  • Almirall Investigational Sites#4
  • Almirall Investigational Sites#8
  • Almirall Investigational Sites#9
  • Almirall Investigational Sites#6
  • Almirall Investigational Sites#14
  • Almirall Investigational Site#7
  • Almirall Investigational Sites#12
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#13
  • Almirall Investigational Sites#15
  • Almirall Investigational Sites#1
  • Almirall Investigational Sites#5
  • Almirall Investigational Sites#4
  • Almirall Investigational Site#16
  • Almirall Investigational Sites#18
  • Almirall Investigational Sites#10
  • Almirall Investigational Sites#11
  • Almirall Investigational Site#2
  • Almirall Investigational Sites#13
  • Almirall Investigational Sites#4
  • Almirall Investigational Sites#1
  • Almirall Investigational Sites#2
  • Almirall Investigational Sites#6
  • Almirall Investigational Sites#5
  • Almirall Investigational Sites#7
  • Almirall Investigational Sites#10
  • Almirall Investigational Sites#9
  • Almirall Investigational Sites#12
  • Almirall Investigational Sites#11
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#8
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#1
  • Almirall Investigational Sites#10
  • Almirall Investigational Sites#8
  • Almirall Investigational Sites#12
  • Almirall Investigational Sites#9
  • Almirall Investigational Sites#19
  • Almirall Investigational Sites#18
  • Almirall Investigational Sites#20
  • Almirall Investigational Sites#7
  • Almirall Investigational Sites#1
  • Almirall Investigational Sites#8
  • Almirall Investigational Sites#24
  • Almirall Investigational Sites#5
  • Almirall Investigational Sites#21
  • Almirall Investigational Sites#16
  • Almirall Investigational Site#11
  • Almirall Investigational Sites#2
  • Almirall Investigational Sites#13
  • Almirall Investigational Sites#4
  • Almirall Investigational Sites#14
  • Almirall Investigational Sites#6
  • Almirall Investigational Sites#15
  • Almirall Investigational Sites#25
  • Almirall Investigational Sites#23
  • Almirall Investigational Site#10
  • Almirall Investigational Sites#7
  • Almirall Investigational Sites#5
  • Almirall Investigational Sites#2
  • Almirall Investigational Sites#14
  • Almirall Investigational Sites#6
  • Almirall Investigational Sites#13
  • Almirall Investigational Sites#10
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#4
  • Almirall Investigational Sites#8
  • Almirall Investigational Sites#12
  • Almirall Investigational Sites#8
  • Almirall Investigational Sites#11
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#10
  • Almirall Investigational Sites#1
  • Almirall Investigational Sites#12
  • Almirall Investigational Sites#15
  • Almirall Investigational Sites#2
  • Almirall Investigational Sites#9
  • Almirall Investigational Sites#4
  • Almirall Investigational Sites#5
  • Almirall Investigational Sites#14
  • Almirall Investigational Sites#6
  • Almirall Investigational Sites#6
  • Almirall Investigational Sites#8
  • Almirall Investigational Sites#7
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#5
  • Almirall Investigational Sites#4
  • Almirall Investigational Sites#3
  • Almirall Investigational Sites#1
  • Almirall Investigational Sites#2
  • Almirall Investigational Sites#7
  • Almirall Investigational Sites#5

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Aclidinium bromide 200 μg bid

Aclidininum bromide 400 μg bid

Placebo

Arm Description

Aclidinium bromide 200 μg twice-daily via inhalation

Aclidinium bromide 400 μg twice-daily via inhalation

Placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment

Secondary Outcome Measures

Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment
Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment
Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment

Full Information

First Posted
October 22, 2009
Last Updated
November 16, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01001494
Brief Title
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (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 main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

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
Chronic Obstructive Pulmonary Disease, antimuscarinic, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
828 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aclidinium bromide 200 μg bid
Arm Type
Experimental
Arm Description
Aclidinium bromide 200 μg twice-daily via inhalation
Arm Title
Aclidininum bromide 400 μg bid
Arm Type
Experimental
Arm Description
Aclidinium bromide 400 μg twice-daily via inhalation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide 200 μg bid
Intervention Description
Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide 400 μg bid
Intervention Description
Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo twice-daily by inhalation for 24 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Time Frame
Baseline and Week 24
Title
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Time Frame
Baseline and Week 24
Title
Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment
Description
Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment
Time Frame
Week 24
Title
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment
Description
Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines). Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%. Current or ex-smokers of ≥10 pack-years. Exclusion Criteria: Patients with no history or current diagnosis of asthma. No evidence of an exacerbation within 6 weeks prior to the screening visit. No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities. No contraindication to use of anticholinergic drugs such as 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#4
City
Benesov
ZIP/Postal Code
256 01
Country
Czech Republic
Facility Name
Almirall Investigational Sites#9
City
Jaromer
ZIP/Postal Code
55 101
Country
Czech Republic
Facility Name
Almirall Investigational Sites#3
City
Liberec
ZIP/Postal Code
460 01
Country
Czech Republic
Facility Name
Almirall Investigational Sites#2
City
Lovosice
ZIP/Postal Code
410 02
Country
Czech Republic
Facility Name
Almirall Investigational Sites#1
City
Neratovice
ZIP/Postal Code
277 11
Country
Czech Republic
Facility Name
Almirall Investigational Sites#11
City
Praha
ZIP/Postal Code
158 00
Country
Czech Republic
Facility Name
Almirall Investigational Sites#6
City
Praha
ZIP/Postal Code
158 00
Country
Czech Republic
Facility Name
Almirall Investigational Sites#12
City
Praha
ZIP/Postal Code
163 00
Country
Czech Republic
Facility Name
Almirall Investigational Sites#7
City
Praha
ZIP/Postal Code
169 00
Country
Czech Republic
Facility Name
Almirall Investigational Sites#10
City
Strakonice
ZIP/Postal Code
386 01
Country
Czech Republic
Facility Name
Almirall Investigational Sites#3
City
Clermont-Ferrand Cedex
ZIP/Postal Code
63003
Country
France
Facility Name
Almirall Investigational Sites#1
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Almirall Investigational Sites#2
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Almirall Investigational Sites#6
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Almirall Investigational Sites#4
City
Toulouse Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Almirall Investigational Sites#8
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Almirall Investigational Sites#9
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Almirall Investigational Sites#6
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Almirall Investigational Sites#14
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Almirall Investigational Site#7
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Almirall Investigational Sites#12
City
Bonn
ZIP/Postal Code
53123
Country
Germany
Facility Name
Almirall Investigational Sites#3
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
Facility Name
Almirall Investigational Sites#13
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Almirall Investigational Sites#15
City
Gelsenkirchen
ZIP/Postal Code
45879
Country
Germany
Facility Name
Almirall Investigational Sites#1
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Almirall Investigational Sites#5
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Almirall Investigational Sites#4
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Almirall Investigational Site#16
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Almirall Investigational Sites#18
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Almirall Investigational Sites#10
City
Koln
ZIP/Postal Code
51069
Country
Germany
Facility Name
Almirall Investigational Sites#11
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Almirall Investigational Site#2
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Almirall Investigational Sites#13
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Almirall Investigational Sites#4
City
Budapest
ZIP/Postal Code
1046
Country
Hungary
Facility Name
Almirall Investigational Sites#1
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Almirall Investigational Sites#2
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
Almirall Investigational Sites#6
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Almirall Investigational Sites#5
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Almirall Investigational Sites#7
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Almirall Investigational Sites#10
City
Dunaüjváros
ZIP/Postal Code
2400
Country
Hungary
Facility Name
Almirall Investigational Sites#9
City
Mátraháza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Almirall Investigational Sites#12
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Almirall Investigational Sites#11
City
Ráckeve
ZIP/Postal Code
2300
Country
Hungary
Facility Name
Almirall Investigational Sites#3
City
Százhalombatta
ZIP/Postal Code
2440
Country
Hungary
Facility Name
Almirall Investigational Sites#8
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Almirall Investigational Sites#3
City
Cagliari
ZIP/Postal Code
09126
Country
Italy
Facility Name
Almirall Investigational Sites#1
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Almirall Investigational Sites#10
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Almirall Investigational Sites#8
City
Cusco
Country
Peru
Facility Name
Almirall Investigational Sites#12
City
Białystok
ZIP/Postal Code
15-003
Country
Poland
Facility Name
Almirall Investigational Sites#9
City
Białystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Almirall Investigational Sites#19
City
Elblag
ZIP/Postal Code
82-307
Country
Poland
Facility Name
Almirall Investigational Sites#18
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Almirall Investigational Sites#20
City
Ilawa
ZIP/Postal Code
14-200
Country
Poland
Facility Name
Almirall Investigational Sites#7
City
Lodz
ZIP/Postal Code
90-430
Country
Poland
Facility Name
Almirall Investigational Sites#1
City
Lodz
ZIP/Postal Code
91-153
Country
Poland
Facility Name
Almirall Investigational Sites#8
City
Lublin
Country
Poland
Facility Name
Almirall Investigational Sites#24
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Almirall Investigational Sites#5
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Almirall Investigational Sites#21
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Almirall Investigational Sites#16
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Almirall Investigational Site#11
City
Proszowice
ZIP/Postal Code
32-100
Country
Poland
Facility Name
Almirall Investigational Sites#2
City
Ruda Slaska
ZIP/Postal Code
41-709
Country
Poland
Facility Name
Almirall Investigational Sites#13
City
Rudka
ZIP/Postal Code
05-320
Country
Poland
Facility Name
Almirall Investigational Sites#4
City
Sopot
ZIP/Postal Code
81-741
Country
Poland
Facility Name
Almirall Investigational Sites#14
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Almirall Investigational Sites#6
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Almirall Investigational Sites#15
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Almirall Investigational Sites#25
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Almirall Investigational Sites#23
City
Wilkowice-Bystra
ZIP/Postal Code
43-365
Country
Poland
Facility Name
Almirall Investigational Site#10
City
Wrocław
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Almirall Investigational Sites#7
City
Ekaterinburg
ZIP/Postal Code
620219 / 620109
Country
Russian Federation
Facility Name
Almirall Investigational Sites#5
City
Kazan
ZIP/Postal Code
420015/420103
Country
Russian Federation
Facility Name
Almirall Investigational Sites#2
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Almirall Investigational Sites#14
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Almirall Investigational Sites#6
City
Moscow
ZIP/Postal Code
127018/127473
Country
Russian Federation
Facility Name
Almirall Investigational Sites#13
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Almirall Investigational Sites#10
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Almirall Investigational Sites#3
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Almirall Investigational Sites#4
City
Saint-Petersburg
ZIP/Postal Code
197089/197022
Country
Russian Federation
Facility Name
Almirall Investigational Sites#8
City
Tomsk
ZIP/Postal Code
634050/634034
Country
Russian Federation
Facility Name
Almirall Investigational Sites#12
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Almirall Investigational Sites#8
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Almirall Investigational Sites#11
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Almirall Investigational Sites#3
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Almirall Investigational Sites#10
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Almirall Investigational Sites#1
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Almirall Investigational Sites#12
City
Cape Town
Country
South Africa
Facility Name
Almirall Investigational Sites#15
City
Cape Town
Country
South Africa
Facility Name
Almirall Investigational Sites#2
City
Durban
Country
South Africa
Facility Name
Almirall Investigational Sites#9
City
George
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Almirall Investigational Sites#4
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Almirall Investigational Sites#5
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Almirall Investigational Sites#14
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Almirall Investigational Sites#6
City
Pretoria
ZIP/Postal Code
181
Country
South Africa
Facility Name
Almirall Investigational Sites#6
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Almirall Investigational Sites#8
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Almirall Investigational Sites#7
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Almirall Investigational Sites#3
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Almirall Investigational Sites#5
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Almirall Investigational Sites#4
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
Almirall Investigational Sites#3
City
Kharkiv
ZIP/Postal Code
61001
Country
Ukraine
Facility Name
Almirall Investigational Sites#1
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Almirall Investigational Sites#2
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Almirall Investigational Sites#7
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Almirall Investigational Sites#5
City
Zaporizhzhya
ZIP/Postal Code
69118
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
28074135
Citation
McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
Results Reference
derived
PubMed Identifier
27215749
Citation
Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.
Results Reference
derived
PubMed Identifier
25234803
Citation
Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.
Results Reference
derived
PubMed Identifier
22441743
Citation
Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.
Results Reference
derived
Links:
URL
http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp
Description
Almirall Corporate Website

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Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

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