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

February 8, 2016 updated by: AstraZeneca

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

933

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

  • Austria
      • Feldbach, Austria, 8330
        • Almirall Investigational Site
      • Feldkirch, Austria, 6800
        • Almirall Investigational Site
      • Grieskirchen, Austria, A-4710
        • Almirall Investigational Site
      • Linz, Austria, 4020
        • Almirall Investigational Site
      • Salzburg, Austria, 5020
        • Almirall Investigational Site
  • Bulgaria
      • Dimitrovgrad, Bulgaria, 6400
        • Almirall Investigational Site
      • Gabrovo, Bulgaria, 5300
        • Almirall Investigational Site
      • Kozlodui, Bulgaria, 3320
        • Almirall Investigational Site
      • Petrich, Bulgaria, 2850
        • Almirall Investigational Site
      • Plovdiv, Bulgaria, 4000
        • Almirall Investigational Site
      • Razgrad, Bulgaria, 7200
        • Almirall Investigational Site
      • Stara Zagora, Bulgaria, 6003
        • Almirall Investigational Site
      • Vidin, Bulgaria, 3700
        • Almirall Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, AB T6G 2B7
        • Almirall Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, BC V5Z 1M9
        • Almirall Investigational Site
      • Vancouver, British Columbia, Canada, BC V7M 2H9
        • Almirall Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, NB E1C 5K4
        • Almirall Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, ON M6H 3M2
        • Almirall Investigational Site
    • Quebec
      • Saint Romuald, Quebec, Canada, QC G6W 5M6
        • Almirall Investigational Site
      • Trois-Rivières, Quebec, Canada, QC G8T 7A1
        • Almirall Investigational Site
  • Czech Republic
      • Karlovy Vary, Czech Republic, 360 09
        • Almirall Investigational Site
      • Kralupy nad Vltavou, Czech Republic, 278 01
        • Almirall Investigational Site
      • Liberec, Czech Republic, 460 63
        • Almirall Investigational Site
      • Ostrava - Hrabuvka, Czech Republic, 700 30
        • Almirall Investigational Site
      • Rokycany, Czech Republic, 337 01
        • Almirall Investigational Site
      • Strakonice, Czech Republic, 386 01
        • Almirall Investigational Site
  • France
      • Nîmes, France, 30900
        • Almirall Investigational Site
      • Perpignan, France, 66025
        • Almirall Investigational Site
      • Vieux Conde, France, 59690
        • Almirall Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Almirall Investigational Site
      • Berlin, Germany, 10629
        • Almirall Investigational Site
      • Berlin, Germany, 10717
        • Almirall Investigational Site
      • Berlin, Germany, 10969
        • Almirall Investigational Site
      • Berlin, Germany, 12043
        • Almirall Investigational Site
      • Berlin, Germany, 13125
        • Almirall Investigational Site
      • Berlin, Germany, 13581
        • Almirall Investigational Site
      • Berlin, Germany, 14059
        • Almirall Investigational Site
      • Bochum, Germany, 44789
        • Almirall Investigational Site
      • Bonn, Germany, 53123
        • Almirall Investigational Site
      • Cologne, Germany, 51069
        • Almirall Investigational Site
      • Cottbus, Germany, 03050
        • Almirall Investigational Site
      • Dortmund, Germany, 44263
        • Almirall Investigational Site
      • Dresden, Germany, 01307
        • Almirall Investigational Site
      • Frankfurt, Germany, 60389
        • Almirall Investigational Site
      • Frankfurt, Germany, 60596
        • Almirall Investigational Site
      • Gauting, Germany, 82131
        • Almirall Investigational Site
      • Großhansdorf, Germany, 22927
        • Almirall Investigational Site
      • Hamburg, Germany, 20253
        • Almirall Investigational Site
      • Hamburg, Germany, 20354
        • Almirall Investigational Site
      • Hamburg, Germany, 22143
        • Almirall Investigational Site
      • Hannover, Germany, 30159
        • Almirall Investigational Site
      • Jena, Germany, 07740
        • Almirall Investigational Site
      • Leipzig, Germany, 4357
        • Almirall Investigational Site
      • Marburg, Germany, 35037
        • Almirall Investigational Site
      • Munich, Germany, 80539
        • Almirall Investigational Site
      • Rüdersdorf, Germany, 15562
        • Almirall Investigational Site
      • Schwabach, Germany, 91126
        • Almirall Investigational Site
      • Wiesbaden, Germany, 65187
        • Almirall Investigational Site
      • Wiesloch, Germany, 69168
        • Almirall Investigational Site
      • Witten, Germany, 58452
        • Almirall Investigational Site
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Almirall Investigational Site
      • Budapest, Hungary, 1191
        • Almirall Investigational Site
      • Budapest, Hungary, 1204
        • Almirall Investigational Site
      • Debrecen, Hungary, H-4032
        • Almirall Investigational Site
      • Komárom, Hungary, 2900
        • Almirall Investigational Site
      • Nyíregyháza, Hungary, 4400
        • Almirall Investigational Site
      • Pécs, Hungary, H-7635
        • Almirall Investigational Site
      • Szazhalombatta, Hungary, H-2400
        • Almirall Investigational Site
      • Szigetszentmiklós, Hungary, H-2310
        • Almirall Investigational Site
      • Vásárosnamény, Hungary, 4800
        • Almirall Investigational Site
  • Italy
      • Pisa, Italy, 56124
        • Almirall Investigational Site
      • Pordenone, Italy, 33170
        • Almirall Investigational Site
      • Trieste, Italy, 34149
        • Almirall Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Almirall Investigational Site
      • Klaipeda, Lithuania, LT-92231
        • Almirall Investigational Site
      • Klaipeda, Lithuania, LT-92288
        • Almirall Investigational Site
      • Vilnius, Lithuania, LT-01117
        • Almirall Investigational Site
  • Netherlands
      • Almere, Netherlands, 1311 RL
        • Almirall Investigational Site
      • Beek, Netherlands, 6191 JW
        • Almirall Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • Almirall Investigational Site
      • Hoofddorp, Netherlands, 2134
        • Almirall Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • Almirall Investigational Site
      • Rotterdam, Netherlands, 3045 PM
        • Almirall Investigational Site
  • Poland
      • Bialystok, Poland, 15-010
        • Almirall Investigational Site
      • Bialystok, Poland, 15-044
        • Almirall Investigational Site
      • Bialystok, Poland, 15-270
        • Almirall Investigational Site
      • Gdansk, Poland, 80-847
        • Almirall Investigational Site
      • Katowice, Poland, 40-752
        • Almirall Investigational Site
      • Krakow, Poland, 31-455
        • Almirall Investigational Site
      • Lodz, Poland, 90-242
        • Almirall Investigational Site
      • Ostrowiec Swietokrzyski, Poland, 27-400
        • Almirall Investigational Site
      • Pila, Poland, 64-920
        • Almirall Investigational Site
      • Poznan, Poland, 60-214
        • Almirall Investigational Site
      • Proszowice, Poland, 32-100
        • Almirall Investigational Site
      • Sopot, Poland, 81-741
        • Almirall Investigational Site
      • Szczecin, Poland, 71-124
        • Almirall Investigational Site
      • Tarnow, Poland, 33-100
        • Almirall Investigational Site
      • Tczew, Poland, 83-110
        • Almirall Investigational Site
      • Warsaw, Poland, 01-138
        • Almirall Investigational Site
      • Wilkowice-Bystra, Poland, 43-365
        • Almirall Investigational Site
  • South Africa
      • Belville, South Africa, 7530
        • Almirall Investigational Site
      • Cape Town, South Africa, 7700
        • Almirall Investigational Site
      • Gauteng, South Africa, 158
        • Almirall Investigational Site
      • Gauteng, South Africa, 1724
        • Almirall Investigational Site
      • Middelburg, South Africa, 1050
        • Almirall Investigational Site
      • Pretoria, South Africa, 0184
        • Almirall Investigational Site
      • Somerset West, South Africa, 7130
        • Almirall Investigational Site
  • Spain
      • Alicante, Spain, 03114
        • Almirall Investigational Site
      • Barcelona, Spain, 08003
        • Almirall Investigational Site
      • Barcelona, Spain, 08025
        • Almirall Investigational Site
      • Barcelona, Spain, 08907
        • Almirall Investigational Site
      • Elda, Spain, 03600
        • Almirall Investigational Site
      • Laredo, Spain, 39770
        • Almirall Investigational Site
      • Madrid, Spain, 28007
        • Almirall Investigational Site
      • Palma de Mallorca, Spain, 07010
        • Almirall Investigational Site
      • Sant Boi de Llobregat, Spain, 08830
        • Almirall Investigational Site
      • Santander, Spain, 38008
        • Almirall Investigational Site
      • Seville, Spain, 41071
        • Almirall Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
        • Almirall Investigational Site
      • Chorley, United Kingdom, PR7 7NA
        • Almirall Investigational Site
      • Glasgow, United Kingdom, G20 0SP
        • Almirall Investigational Site
      • Liverpool, United Kingdom, L22 0LG
        • Almirall Investigational Site
      • Manchester, United Kingdom, M15 6SX
        • Almirall Investigational Site
      • Middlesex, United Kingdom, HA6 2RN
        • Almirall Investigational Site
      • Reading, United Kingdom, RG2 0TG
        • Almirall Investigational Site
      • Sidcup, United Kingdom, DA14 6LT
        • Almirall Investigational Site

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:

  • 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aclidinium Bromide / Formoterol Fumarate
Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
Drug: Aclidinium Bromide / Formoterol Fumarate
Active Comparator: Salmeterol / Fluticasone propionate
Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
Drug: Salmeterol / Fluticasone
Other Names:
  • Advair
  • Seretide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
Time Frame: At Week 24
Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration
At Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transition Dyspnoea Index (TDI) Focal Score at Week 24
Time Frame: 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)
At Week 24

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Esther Garcia, Ph.D., Global Medicines Development

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

September 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M/40464/39
  • 2013-000116-14 (EudraCT Number)

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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