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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
933

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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