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

NCT01908140 | Completed Phase 3 Results

• 2 other identifiers: M/40464/392013-000116-14
• Study Type: interventional
• Target: 933
• Locations: 14 countries
• Sites: 126

Brief Summary

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)

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Peak Forced Expiratory Volume in One Second (FEV1) at Week 24

  Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration

  At Week 24

Secondary Outcomes (1)

• Transition Dyspnoea Index (TDI) Focal Score at Week 24

  At Week 24

Study Arms (2)

Aclidinium Bromide / Formoterol Fumarate

EXPERIMENTAL

Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks

Drug: Aclidinium Bromide / Formoterol Fumarate

Salmeterol / Fluticasone propionate

ACTIVE COMPARATOR

Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks

Drug: Salmeterol / Fluticasone

Interventions

Aclidinium Bromide / Formoterol Fumarate DRUG

Aclidinium Bromide / Formoterol Fumarate

Salmeterol / Fluticasone DRUG

Also known as: Seretide, Advair

Salmeterol / Fluticasone propionate

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (126)

Almirall Investigational Site

Feldbach, 8330, Austria

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Almirall Investigational Site

Feldkirch, 6800, Austria

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Almirall Investigational Site

Grieskirchen, A-4710, Austria

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Linz, 4020, Austria

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Salzburg, 5020, Austria

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Dimitrovgrad, 6400, Bulgaria

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Gabrovo, 5300, Bulgaria

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Kozloduy, 3320, Bulgaria

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Petrich, 2850, Bulgaria

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Plovdiv, 4000, Bulgaria

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Razgrad, 7200, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Vidin, 3700, Bulgaria

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Edmonton, Alberta, AB T6G 2B7, Canada

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Vancouver, British Columbia, BC V5Z 1M9, Canada

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Vancouver, British Columbia, BC V7M 2H9, Canada

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Moncton, New Brunswick, NB E1C 5K4, Canada

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Toronto, Ontario, ON M6H 3M2, Canada

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Saint Romuald, Quebec, QC G6W 5M6, Canada

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Trois-Rivières, Quebec, QC G8T 7A1, Canada

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Karlovy Vary, 360 09, Czechia

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Kralupy nad Vltavou, 278 01, Czechia

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Liberec, 460 63, Czechia

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Ostrava - Hrabuvka, 700 30, Czechia

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Rokycany, 337 01, Czechia

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Strakonice, 386 01, Czechia

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Nîmes, 30900, France

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Perpignan, 66025, France

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Vieux-Condé, 59690, France

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Berlin, 10117, Germany

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Berlin, 10629, Germany

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Berlin, 10717, Germany

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Berlin, 10969, Germany

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Berlin, 12043, Germany

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Berlin, 13125, Germany

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Berlin, 13581, Germany

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Berlin, 14059, Germany

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Bochum, 44789, Germany

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Bonn, 53123, Germany

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Cologne, 51069, Germany

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Cottbus, 03050, Germany

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Dortmund, 44263, Germany

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Dresden, 01307, Germany

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Frankfurt, 60389, Germany

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Frankfurt, 60596, Germany

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Gauting, 82131, Germany

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Großhansdorf, 22927, Germany

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Hamburg, 20253, Germany

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Hamburg, 20354, Germany

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Hamburg, 22143, Germany

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Hanover, 30159, Germany

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Jena, 07740, Germany

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Leipzig, 4357, Germany

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Marburg, 35037, Germany

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Munich, 80539, Germany

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Rüdersdorf, 15562, Germany

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Schwabach, 91126, Germany

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Wiesbaden, 65187, Germany

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Wiesloch, 69168, Germany

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Witten, 58452, Germany

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Balassagyarmat, 2660, Hungary

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Budapest, 1191, Hungary

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Budapest, 1204, Hungary

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Debrecen, H-4032, Hungary

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Komárom, 2900, Hungary

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Nyíregyháza, 4400, Hungary

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Pécs, H-7635, Hungary

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Százhalombatta, H-2400, Hungary

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Szigetszentmiklós, H-2310, Hungary

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Vásárosnamény, 4800, Hungary

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Pisa, 56124, Italy

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Pordenone, 33170, Italy

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Trieste, 34149, Italy

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Kaunas, LT-50009, Lithuania

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Klaipėda, LT-92231, Lithuania

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Klaipėda, LT-92288, Lithuania

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Vilnius, LT-01117, Lithuania

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Almirall Investigational Site

Almere Stad, 1311 RL, Netherlands

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Beek, 6191 JW, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Hoofddorp, 2134, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Rotterdam, 3045 PM, Netherlands

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Almirall Investigational Site

Bialystok, 15-010, Poland

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Bialystok, 15-044, Poland

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Bialystok, 15-270, Poland

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Gdansk, 80-847, Poland

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Katowice, 40-752, Poland

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Krakow, 31-455, Poland

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Lodz, 90-242, Poland

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Almirall Investigational Site

Ostrowiec Świętokrzyski, 27-400, Poland

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Piła, 64-920, Poland

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Poznan, 60-214, Poland

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Proszowice, 32-100, Poland

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Sopot, 81-741, Poland

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Szczecin, 71-124, Poland

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Tarnów, 33-100, Poland

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Tczew, 83-110, Poland

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Warsaw, 01-138, Poland

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Almirall Investigational Site

Wilkowice-Bystra, 43-365, Poland

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Belville, 7530, South Africa

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Cape Town, 7700, South Africa

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Gauteng, 158, South Africa

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Gauteng, 1724, South Africa

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Middelburg, 1050, South Africa

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Pretoria, 0184, South Africa

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Almirall Investigational Site

Somerset West, 7130, South Africa

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Almirall Investigational Site

Alicante, 03114, Spain

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Almirall Investigational Site

Barcelona, 08003, Spain

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Almirall Investigational Site

Barcelona, 08025, Spain

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Almirall Investigational Site

Barcelona, 08907, Spain

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Almirall Investigational Site

Elda, 03600, Spain

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Almirall Investigational Site

Laredo, 39770, Spain

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Almirall Investigational Site

Madrid, 28007, Spain

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Almirall Investigational Site

Palma de Mallorca, 07010, Spain

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Almirall Investigational Site

Sant Boi de Llobregat, 08830, Spain

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Almirall Investigational Site

Santander, 38008, Spain

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Almirall Investigational Site

Seville, 41071, Spain

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Almirall Investigational Site

Birmingham, B15 2SQ, United Kingdom

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Almirall Investigational Site

Chorley, PR7 7NA, United Kingdom

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Glasgow, G20 0SP, United Kingdom

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Liverpool, L22 0LG, United Kingdom

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Manchester, M15 6SX, United Kingdom

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Almirall Investigational Site

Middlesex, HA6 2RN, United Kingdom

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Almirall Investigational Site

Reading, RG2 0TG, United Kingdom

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Almirall Investigational Site

Sidcup, DA14 6LT, United Kingdom

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Related Publications (1)

• Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M, Kirsten AM, Beier J, Seoane B, Segarra RM, Leselbaum A. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016 Oct;48(4):1030-1039. doi: 10.1183/13993003.00216-2016. Epub 2016 Aug 4.

  PMID: 27492833 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide; Formoterol Fumarate; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Salmeterol Xinafoate; Albuterol; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Information Center
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Esther Garcia, Ph.D.

  Global Medicines Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-02

Locations

NL (6); PL (17); GB (8); ZA (7); CA (7); FR (3); ES (11); IT (3); LI (4); AU (5); HU (10); CZ (6); DE (31); BU (8)