Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

November 16, 2016 updated by: AstraZeneca
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

804

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1143ABH
        • Almirall Investigational Sites#800
      • Buenos Aires, Argentina, C1221ADC
        • Almirall Investigational Sites#744
      • Buenos Aires, Argentina, C1405DCS
        • Almirall Investigational Sites#792
      • Buenos Aires, Argentina, C1416DVR
        • Almirall Investigational Sites#793
      • Buenos Aires, Argentina, C1424BSF
        • Almirall Investigational Sites#799
      • Buenos Aires, Argentina, C1425BEA
        • Almirall Investigational Sites#795
      • Buenos Aires, Argentina, C1425DTG
        • Almirall Investigational Sites#801
      • Buenos Aires, Argentina, C1426ABO
        • Almirall Investigational Sites#791
      • El Palomar, Argentina, 1684
        • Almirall Investigational Sites#797
      • La Plata, Argentina, 1900
        • Almirall Investigational Sites#740
      • Rosario, Argentina, S2000DBS
        • Almirall Investigational Sites#801
      • San Miguel de Tucuman, Argentina, 4000
        • Almirall Investigational Sites#796
      • Vicente López, Argentina, 1602
        • Almirall Investigational Sites#794
  • Australia
      • Adelaide, Australia, 5061
        • Almirall Investigational Sites#807
      • Auchenflower, Australia, 2031
        • Almirall Investigational Sites#834
      • Bankstown, Australia, 2200
        • Almirall Investigational Sites#808
      • Boxhill, Australia, 3128
        • Almirall Investigational Sites#806
      • Cairns, Australia, 4870
        • Almirall Investigational Sites#814
      • Camperdown, Australia, 2050
        • Almirall Investigational Sites#813
      • Carina Heights, Australia, 4152
        • Almirall Investigational Sites#811
      • Clayton, Australia, 3168
        • Almirall Investigational Sites#803
      • Kippa Ring, Australia, 4021
        • Almirall Investigational Sites#809
      • Nedlands, Australia, 6009
        • Almirall Investigational Sites#8121
      • Nedlands, Australia, 6009
        • Almirall Investigational Sites#812
      • Toorak Gardens, Australia, 5065
        • Almirall Investigational Sites#805
      • Woodville, Australia, 5011
        • Almirall Investigational Sites#815
  • Canada
      • Edmonton, Canada, T5X 4Z9
        • Almirall Investigational Sites#823
      • Kelowna, Canada, V1Y 9L8
        • Almirall Investigational Sites#818
      • Montreal, Canada, H4J 1C5
        • Almirall Investigational Sites#822
      • Niagara Falls, Canada, L2G 1J4
        • Almirall Investigational Sites#817
      • Ottawa, Canada, K1Y 4E9
        • Almirall Investigational Sites#821
      • Ottawa, Canada, K1Y 4G2
        • Almirall Investigational Sites#935
      • Toronto, Ontario, Canada, M6H 3M2
        • Almirall Investigational Sites#820
  • Mexico
      • Monterrey, Mexico, 64460
        • Almirall Investigational Sites#827
      • Zapopan, Mexico, 452000
        • Almirall Investigational Sites#826
  • New Zealand
      • Auckland, New Zealand, 1640
        • Almirall Investigational Sites#936
      • Grafton, New Zealand, 1001
        • Almirall Investigational Sites#830
      • Tauranga, New Zealand, 3140
        • Almirall Investigational Sites#832
  • South Africa
      • Amanzimtoti, South Africa, 4125
        • Almirall Investigational Sites#833
      • Bloemfontain, South Africa, 9317
        • Almirall Investigational Sites#836
      • Bloemfontein, South Africa, 9301
        • Almirall Investigational Sites#841
      • Cape Town, South Africa, 7130
        • Almirall Investigational Sites#839
      • Cape Town, South Africa, 7700
        • Almirall Investigational Sites#835
      • Cape Town, South Africa, 7764
        • Almirall Investigational Sites#837
      • Cape Town, South Africa, 8001
        • Almirall Investigational Sites#840
      • Durban, South Africa, 4001
        • Almirall Investigational Sites#834
      • Johannesburg, South Africa, 2193
        • Almirall Investigational Sites#838
  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • Almirall Investigational Sites#926
      • Ozark, Alabama, United States, 36360
        • Almirall Investigational Sites#858
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Almirall Investigational Sites#900
      • Tucson, Arizona, United States, 85715
        • Almirall Investigational Sites#899
      • Tucson, Arizona, United States, 85723
        • Almirall Investigational Sites#855
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-7199
        • Almirall Investigational Sites#879
    • California
      • Carmichael, California, United States, 95837
        • Almirall Investigational Sites#932
      • Encinitas, California, United States, 92024
        • Almirall Investigational Sites#904
      • Fullerton, California, United States, 92835
        • Almirall Investigational Sites#903
      • Los Angeles, California, United States, 90048
        • Almirall Investigational Sites#930
      • Los Angeles, California, United States, 90095-1690
        • Almirall Investigational Sites#922
      • North Hills, California, United States, 91343
        • Almirall Investigational Sites#893
      • Rancho Mirage, California, United States, 92270
        • Almirall Investigational Sites#871
      • Riverside, California, United States, 92506
        • Almirall Investigational Sites#902
      • San Diego, California, United States, 92120
        • Almirall Investigational Sites#850
      • San Diego, California, United States, 92120
        • Almirall Investigational Sites#897
      • Torrance, California, United States, 90509
        • Almirall Investigational Sites#924
      • Walnut Creek, California, United States, 94598
        • Almirall Investigational Sites#882
    • Colorado
      • Denver, Colorado, United States, 80206
        • Almirall Investigational Sites#895
      • Fort Collins, Colorado, United States, 80528
        • Almirall Investigational Sites#880
      • Wheat Ridge, Colorado, United States, 80033
        • Almirall Investigational Sites#888
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Almirall Investigational Sites#952
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Almirall Investigational Sites#844
      • Clearwater, Florida, United States, 33765
        • Almirall Investigational Sites#863
      • Deland, Florida, United States, 32720
        • Almirall Investigational Sites#152
      • Melbourne, Florida, United States, 32935
        • Almirall Investigational Sites#8533
      • Tamarac, Florida, United States, 33321
        • Almirall Investigational Sites#920
      • Tampa, Florida, United States, 33603
        • Almirall Investigational Sites#894
      • Tampa, Florida, United States, 33613
        • Almirall Investigational Sites#889
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Almirall Investigational Sites#890
      • Decatur, Georgia, United States, 30033
        • Almirall Investigational Sites#907
      • Gainesville, Georgia, United States, 30501
        • Almirall Investigational Sites#931
      • Marietta, Georgia, United States, 30060
        • Almirall Investigational Sites#849
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Almirall Investigational Sites#933
      • Hines, Illinois, United States, 60141
        • Almirall Investigational Sites#872
      • River Forest, Illinois, United States, 60305
        • Almirall Investigational Sites#892
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Almirall Investigational Sites#864
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Almirall Investigational Sites#876
      • Florence, Kentucky, United States, 41042
        • Almirall Investigational Sites#923
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Almirall Investigational Sites#866
      • Shreveport, Louisiana, United States, 71103
        • Almirall Investigational Sites#911
    • Maine
      • Biddeford, Maine, United States, 04005
        • Almirall Investigational Sites#883
      • Lewiston, Maine, United States, 04240
        • Almirall Investigational Sites#976
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Almirall Investigational Sites#843
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Almirall Investigational Sites#868
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Almirall Investigational Sites#884
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Almirall Investigational Sites#916
    • Montana
      • Butte, Montana, United States, 59701
        • Almirall Investigational Sites#906
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2465
        • Almirall Investigational Sites#909
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Almirall Investigational Sites#846
      • Newark, New Jersey, United States, 07112
        • Almirall Investigational Sites#885
      • Summit, New Jersey, United States, 07901
        • Almirall Investigational Sites#921
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Almirall Investigational Sites#896
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Almirall Investigational Sites#861
      • Charlotte, North Carolina, United States, 28207
        • Almirall Investigational Sites#919
      • Elizabeth City, North Carolina, United States, 27909
        • Almirall Investigational Sites#878
      • Williamston, North Carolina, United States, 29697
        • Almirall Investigational Sites#842
      • Winston Salem, North Carolina, United States, 27103
        • Almirall Investigational Sites#915
    • Ohio
      • Cincinatti, Ohio, United States, 45231
        • Almirall Investigational Sites#848
      • Cincinnati, Ohio, United States, 45242
        • Almirall Investigational Sites#870
      • Columbus, Ohio, United States, 43215
        • Almirall Investigational Sites#847
      • Sylvania, Ohio, United States, 43560
        • Almirall Investigational Sites#928
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Almirall Investigational Sites#905
      • Medford, Oregon, United States, 97504
        • Almirall Investigational Sites#860
      • Medford, Oregon, United States, 97504
        • Almirall Investigational Sites#886
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Almirall Investigational Sites#910
      • Greer, South Carolina, United States, 29651
        • Almirall Investigational Sites#918
    • Texas
      • Dallas, Texas, United States, 75246
        • Almirall Investigational Sites#898
      • Fort Worth, Texas, United States, 76104
        • Almirall Investigational Sites#854
      • Houston, Texas, United States, 77030
        • Almirall Investigational Sites#875
      • San Antonio, Texas, United States, 78229
        • Almirall Investigational Sites#881
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Almirall Investigational Sites#951
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Almirall Investigational Sites#856

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo by inhalation
Drug: Placebo
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
Experimental: Aclidinium 200 μg once-daily
Aclidinium bromide 200 μg once-daily by inhalation
Drug: Aclidinium bromide
Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough FEV1 (L) at 28 Weeks on Treatment
Time Frame: 28 weeks
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
28 weeks
Trough FEV1 (L) at 12 Weeks on Treatment
Time Frame: 12 weeks
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
Time Frame: 52 weeks
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
52 weeks
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
Time Frame: 52 weeks
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.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (Estimate)

July 31, 2006

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M/34273/31
  • ACCLAIM II (Other Identifier: Almirall,S.A.)
  • CT000742 (Other Identifier: Almirall,S.A.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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