Clinical trial NCT01908140: Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 933
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
timeFrame: At Week 24
Secondary outcomes:
measure: Transition Dyspnoea Index (TDI) Focal Score at Week 24
timeFrame: At Week 24
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: Almirall Investigational Site
city: Feldkirch
country: Austria
facility: Almirall Investigational Site
city: Grieskirchen
country: Austria
facility: Almirall Investigational Site
city: Linz
country: Austria
facility: Almirall Investigational Site
city: Salzburg
country: Austria
facility: Almirall Investigational Site
city: Dimitrovgrad
country: Bulgaria
facility: Almirall Investigational Site
city: Gabrovo
country: Bulgaria
facility: Almirall Investigational Site
city: Kozlodui
country: Bulgaria
facility: Almirall Investigational Site
city: Petrich
country: Bulgaria
facility: Almirall Investigational Site
city: Plovdiv
country: Bulgaria
facility: Almirall Investigational Site
city: Razgrad
country: Bulgaria
facility: Almirall Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Almirall Investigational Site
city: Vidin
country: Bulgaria
facility: Almirall Investigational Site
city: Edmonton
country: Canada
facility: Almirall Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Almirall Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Almirall Investigational Site
state: British Columbia
city: Moncton
country: Canada
facility: Almirall Investigational Site
state: New Brunswick
city: Toronto
country: Canada
facility: Almirall Investigational Site
state: Ontario
city: Saint Romuald
country: Canada
facility: Almirall Investigational Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: Almirall Investigational Site
state: Quebec
city: Karlovy Vary
country: Czech Republic
facility: Almirall Investigational Site
city: Kralupy nad Vltavou
country: Czech Republic
facility: Almirall Investigational Site
city: Liberec
country: Czech Republic
facility: Almirall Investigational Site
city: Ostrava - Hrabuvka
country: Czech Republic
facility: Almirall Investigational Site
city: Rokycany
country: Czech Republic
facility: Almirall Investigational Site
city: Strakonice
country: Czech Republic
facility: Almirall Investigational Site
city: Nîmes
country: France
facility: Almirall Investigational Site
city: Perpignan
country: France
facility: Almirall Investigational Site
city: Vieux Conde
country: France
facility: Almirall Investigational Site
city: Berlin
country: Germany
facility: Almirall Investigational Site
city: Berlin
country: Germany
facility: Almirall Investigational Site
city: Berlin
country: Germany
facility: Almirall Investigational Site
city: Berlin
country: Germany
facility: Almirall Investigational Site
city: Berlin
country: Germany
facility: Almirall Investigational Site
city: Berlin
country: Germany
facility: Almirall Investigational Site
city: Berlin
country: Germany
facility: Almirall Investigational Site
city: Berlin
country: Germany
facility: Almirall Investigational Site
city: Bochum
country: Germany
facility: Almirall Investigational Site
city: Bonn
country: Germany
facility: Almirall Investigational Site
city: Cologne
country: Germany
facility: Almirall Investigational Site
city: Cottbus
country: Germany
facility: Almirall Investigational Site
city: Dortmund
country: Germany
facility: Almirall Investigational Site
city: Dresden
country: Germany
facility: Almirall Investigational Site
city: Frankfurt
country: Germany
facility: Almirall Investigational Site
city: Frankfurt
country: Germany
facility: Almirall Investigational Site
city: Gauting
country: Germany
facility: Almirall Investigational Site
city: Großhansdorf
country: Germany
facility: Almirall Investigational Site
city: Hamburg
country: Germany
facility: Almirall Investigational Site
city: Hamburg
country: Germany
facility: Almirall Investigational Site
city: Hamburg
country: Germany
facility: Almirall Investigational Site
city: Hannover
country: Germany
facility: Almirall Investigational Site
city: Jena
country: Germany
facility: Almirall Investigational Site
city: Leipzig
country: Germany
facility: Almirall Investigational Site
city: Marburg
country: Germany
facility: Almirall Investigational Site
city: Munich
country: Germany
facility: Almirall Investigational Site
city: Rüdersdorf
country: Germany
facility: Almirall Investigational Site
city: Schwabach
country: Germany
facility: Almirall Investigational Site
city: Wiesbaden
country: Germany
facility: Almirall Investigational Site
city: Wiesloch
country: Germany
facility: Almirall Investigational Site
city: Witten
country: Germany
facility: Almirall Investigational Site
city: Balassagyarmat
country: Hungary
facility: Almirall Investigational Site
city: Budapest
country: Hungary
facility: Almirall Investigational Site
city: Budapest
country: Hungary
facility: Almirall Investigational Site
city: Debrecen
country: Hungary
facility: Almirall Investigational Site
city: Komárom
country: Hungary
facility: Almirall Investigational Site
city: Nyíregyháza
country: Hungary
facility: Almirall Investigational Site
city: Pécs
country: Hungary
facility: Almirall Investigational Site
city: Szazhalombatta
country: Hungary
facility: Almirall Investigational Site
city: Szigetszentmiklós
country: Hungary
facility: Almirall Investigational Site
city: Vásárosnamény
country: Hungary
facility: Almirall Investigational Site
city: Pisa
country: Italy
facility: Almirall Investigational Site
city: Pordenone
country: Italy
facility: Almirall Investigational Site
city: Trieste
country: Italy
facility: Almirall Investigational Site
city: Kaunas
country: Lithuania
facility: Almirall Investigational Site
city: Klaipeda
country: Lithuania
facility: Almirall Investigational Site
city: Klaipeda
country: Lithuania
facility: Almirall Investigational Site
city: Vilnius
country: Lithuania
facility: Almirall Investigational Site
city: Almere
country: Netherlands
facility: Almirall Investigational Site
city: Beek
country: Netherlands
facility: Almirall Investigational Site
city: Eindhoven
country: Netherlands
facility: Almirall Investigational Site
city: Hoofddorp
country: Netherlands
facility: Almirall Investigational Site
city: Leeuwarden
country: Netherlands
facility: Almirall Investigational Site
city: Rotterdam
country: Netherlands
facility: Almirall Investigational Site
city: Bialystok
country: Poland
facility: Almirall Investigational Site
city: Bialystok
country: Poland
facility: Almirall Investigational Site
city: Bialystok
country: Poland
facility: Almirall Investigational Site
city: Gdansk
country: Poland
facility: Almirall Investigational Site
city: Katowice
country: Poland
facility: Almirall Investigational Site
city: Krakow
country: Poland
facility: Almirall Investigational Site
city: Lodz
country: Poland
facility: Almirall Investigational Site
city: Ostrowiec Swietokrzyski
country: Poland
facility: Almirall Investigational Site
city: Pila
country: Poland
facility: Almirall Investigational Site
city: Poznan
country: Poland
facility: Almirall Investigational Site
city: Proszowice
country: Poland
facility: Almirall Investigational Site
city: Sopot
country: Poland
facility: Almirall Investigational Site
city: Szczecin
country: Poland
facility: Almirall Investigational Site
city: Tarnow
country: Poland
facility: Almirall Investigational Site
city: Tczew
country: Poland
facility: Almirall Investigational Site
city: Warsaw
country: Poland
facility: Almirall Investigational Site
city: Wilkowice-Bystra
country: Poland
facility: Almirall Investigational Site
city: Belville
country: South Africa
facility: Almirall Investigational Site
city: Cape Town
country: South Africa
facility: Almirall Investigational Site
city: Gauteng
country: South Africa
facility: Almirall Investigational Site
city: Gauteng
country: South Africa
facility: Almirall Investigational Site
city: Middelburg
country: South Africa
facility: Almirall Investigational Site
city: Pretoria
country: South Africa
facility: Almirall Investigational Site
city: Somerset West
country: South Africa
facility: Almirall Investigational Site
city: Alicante
country: Spain
facility: Almirall Investigational Site
city: Barcelona
country: Spain
facility: Almirall Investigational Site
city: Barcelona
country: Spain
facility: Almirall Investigational Site
city: Barcelona
country: Spain
facility: Almirall Investigational Site
city: Elda
country: Spain
facility: Almirall Investigational Site
city: Laredo
country: Spain
facility: Almirall Investigational Site
city: Madrid
country: Spain
facility: Almirall Investigational Site
city: Palma de Mallorca
country: Spain
facility: Almirall Investigational Site
city: Sant Boi de Llobregat
country: Spain
facility: Almirall Investigational Site
city: Santander
country: Spain
facility: Almirall Investigational Site
city: Seville
country: Spain
facility: Almirall Investigational Site
city: Birmingham
country: United Kingdom
facility: Almirall Investigational Site
city: Chorley
country: United Kingdom
facility: Almirall Investigational Site
city: Glasgow
country: United Kingdom
facility: Almirall Investigational Site
city: Liverpool
country: United Kingdom
facility: Almirall Investigational Site
city: Manchester
country: United Kingdom
facility: Almirall Investigational Site
city: Middlesex
country: United Kingdom
facility: Almirall Investigational Site
city: Reading
country: United Kingdom
facility: Almirall Investigational Site
city: Sidcup
country: United Kingdom
facility: Almirall Investigational Site
Study officials:
affiliation: Global Medicines Development
name: Esther Garcia, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.