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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908140
• Other study ID #: M/40464/39
• Secondary ID: 2013-000116-14
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2013
• Last updated: February 8, 2016
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen (BASG) / Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES)Bulgaria: Bulgarian Drug AgencyCanada: Health Canada, Therapeutics Products DirectorateCzech Republic: State Institute for Drug ControlFrance: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Agenzia Italiana del Farmaco (AIFA)Lithuania: State Medicines Control Agency of LithuaniaNetherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow Medycznych i Produktow BiobojczychSouth Africa: Medicines Control Council, Registrar of MedicinesSpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 933
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium Bromide / Formoterol Fumarate

• Salmeterol / Fluticasone

Locations

Country	Name	City	State
Austria	Almirall Investigational Site	Feldbach
Austria	Almirall Investigational Site	Feldkirch
Austria	Almirall Investigational Site	Grieskirchen
Austria	Almirall Investigational Site	Linz
Austria	Almirall Investigational Site	Salzburg
Bulgaria	Almirall Investigational Site	Dimitrovgrad
Bulgaria	Almirall Investigational Site	Gabrovo
Bulgaria	Almirall Investigational Site	Kozlodui
Bulgaria	Almirall Investigational Site	Petrich
Bulgaria	Almirall Investigational Site	Plovdiv
Bulgaria	Almirall Investigational Site	Razgrad
Bulgaria	Almirall Investigational Site	Stara Zagora
Bulgaria	Almirall Investigational Site	Vidin
Canada	Almirall Investigational Site	Edmonton	Alberta
Canada	Almirall Investigational Site	Moncton	New Brunswick
Canada	Almirall Investigational Site	Saint Romuald	Quebec
Canada	Almirall Investigational Site	Toronto	Ontario
Canada	Almirall Investigational Site	Trois-Rivières	Quebec
Canada	Almirall Investigational Site	Vancouver	British Columbia
Canada	Almirall Investigational Site	Vancouver	British Columbia
Czech Republic	Almirall Investigational Site	Karlovy Vary
Czech Republic	Almirall Investigational Site	Kralupy nad Vltavou
Czech Republic	Almirall Investigational Site	Liberec
Czech Republic	Almirall Investigational Site	Ostrava - Hrabuvka
Czech Republic	Almirall Investigational Site	Rokycany
Czech Republic	Almirall Investigational Site	Strakonice
France	Almirall Investigational Site	Nîmes
France	Almirall Investigational Site	Perpignan
France	Almirall Investigational Site	Vieux Conde
Germany	Almirall Investigational Site	Berlin
Germany	Almirall Investigational Site	Berlin
Germany	Almirall Investigational Site	Berlin
Germany	Almirall Investigational Site	Berlin
Germany	Almirall Investigational Site	Berlin
Germany	Almirall Investigational Site	Berlin
Germany	Almirall Investigational Site	Berlin
Germany	Almirall Investigational Site	Berlin
Germany	Almirall Investigational Site	Bochum
Germany	Almirall Investigational Site	Bonn
Germany	Almirall Investigational Site	Cologne
Germany	Almirall Investigational Site	Cottbus
Germany	Almirall Investigational Site	Dortmund
Germany	Almirall Investigational Site	Dresden
Germany	Almirall Investigational Site	Frankfurt
Germany	Almirall Investigational Site	Frankfurt
Germany	Almirall Investigational Site	Gauting
Germany	Almirall Investigational Site	Großhansdorf
Germany	Almirall Investigational Site	Hamburg
Germany	Almirall Investigational Site	Hamburg
Germany	Almirall Investigational Site	Hamburg
Germany	Almirall Investigational Site	Hannover
Germany	Almirall Investigational Site	Jena
Germany	Almirall Investigational Site	Leipzig
Germany	Almirall Investigational Site	Marburg
Germany	Almirall Investigational Site	Munich
Germany	Almirall Investigational Site	Rüdersdorf
Germany	Almirall Investigational Site	Schwabach
Germany	Almirall Investigational Site	Wiesbaden
Germany	Almirall Investigational Site	Wiesloch
Germany	Almirall Investigational Site	Witten
Hungary	Almirall Investigational Site	Balassagyarmat
Hungary	Almirall Investigational Site	Budapest
Hungary	Almirall Investigational Site	Budapest
Hungary	Almirall Investigational Site	Debrecen
Hungary	Almirall Investigational Site	Komárom
Hungary	Almirall Investigational Site	Nyíregyháza
Hungary	Almirall Investigational Site	Pécs
Hungary	Almirall Investigational Site	Szazhalombatta
Hungary	Almirall Investigational Site	Szigetszentmiklós
Hungary	Almirall Investigational Site	Vásárosnamény
Italy	Almirall Investigational Site	Pisa
Italy	Almirall Investigational Site	Pordenone
Italy	Almirall Investigational Site	Trieste
Lithuania	Almirall Investigational Site	Kaunas
Lithuania	Almirall Investigational Site	Klaipeda
Lithuania	Almirall Investigational Site	Klaipeda
Lithuania	Almirall Investigational Site	Vilnius
Netherlands	Almirall Investigational Site	Almere
Netherlands	Almirall Investigational Site	Beek
Netherlands	Almirall Investigational Site	Eindhoven
Netherlands	Almirall Investigational Site	Hoofddorp
Netherlands	Almirall Investigational Site	Leeuwarden
Netherlands	Almirall Investigational Site	Rotterdam
Poland	Almirall Investigational Site	Bialystok
Poland	Almirall Investigational Site	Bialystok
Poland	Almirall Investigational Site	Bialystok
Poland	Almirall Investigational Site	Gdansk
Poland	Almirall Investigational Site	Katowice
Poland	Almirall Investigational Site	Krakow
Poland	Almirall Investigational Site	Lodz
Poland	Almirall Investigational Site	Ostrowiec Swietokrzyski
Poland	Almirall Investigational Site	Pila
Poland	Almirall Investigational Site	Poznan
Poland	Almirall Investigational Site	Proszowice
Poland	Almirall Investigational Site	Sopot
Poland	Almirall Investigational Site	Szczecin
Poland	Almirall Investigational Site	Tarnow
Poland	Almirall Investigational Site	Tczew
Poland	Almirall Investigational Site	Warsaw
Poland	Almirall Investigational Site	Wilkowice-Bystra
South Africa	Almirall Investigational Site	Belville
South Africa	Almirall Investigational Site	Cape Town
South Africa	Almirall Investigational Site	Gauteng
South Africa	Almirall Investigational Site	Gauteng
South Africa	Almirall Investigational Site	Middelburg
South Africa	Almirall Investigational Site	Pretoria
South Africa	Almirall Investigational Site	Somerset West
Spain	Almirall Investigational Site	Alicante
Spain	Almirall Investigational Site	Barcelona
Spain	Almirall Investigational Site	Barcelona
Spain	Almirall Investigational Site	Barcelona
Spain	Almirall Investigational Site	Elda
Spain	Almirall Investigational Site	Laredo
Spain	Almirall Investigational Site	Madrid
Spain	Almirall Investigational Site	Palma de Mallorca
Spain	Almirall Investigational Site	Sant Boi de Llobregat
Spain	Almirall Investigational Site	Santander
Spain	Almirall Investigational Site	Seville
United Kingdom	Almirall Investigational Site	Birmingham
United Kingdom	Almirall Investigational Site	Chorley
United Kingdom	Almirall Investigational Site	Glasgow
United Kingdom	Almirall Investigational Site	Liverpool
United Kingdom	Almirall Investigational Site	Manchester
United Kingdom	Almirall Investigational Site	Middlesex
United Kingdom	Almirall Investigational Site	Reading
United Kingdom	Almirall Investigational Site	Sidcup

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Bulgaria,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Lithuania,  Netherlands,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Transition Dyspnoea Index (TDI) Focal Score 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	No

External Links

•   CSR Synopsis