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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
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 COPD, Lung function, Exacerbations, Quality of Life

Eligibility Criteria

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

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

First Posted
August 10, 2006
Last Updated
November 16, 2016
Sponsor
AstraZeneca
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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:
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Almirall Investigational Sites#947
City
Escaldes
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Andorra
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Almirall Investigational Sites#645
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Graz
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Austria
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Almirall Investigational Sites#646
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Innsbruck
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Linz
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Austria
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Wien
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Wien
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Aalst
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Brussels
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Namur
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Burgas
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Pleven
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Plovdiv
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Russe
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Sofia
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Sofia
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Sofia
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Varna
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Veliko Tarnovo
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Lovosice
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Plzen
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Tabor
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Tremosna
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Paris
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Berlin
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Berlin
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Berlin
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Jena
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Mainz
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Budapest
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Iasi
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Moscow region
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Moscow
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Moscow
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Moscow
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Moscow
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Moscow
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Moscow
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Moscow
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saint Petersburg
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Saint Petersburg
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Saint Petersburg
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Saint Petersburg
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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)

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