Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)

NCT02467452 | Completed Phase 3

• 2 other identifiers: CCD-05993AA1-072014-001487-35
• Study Type: interventional
• Target: 1,479
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to demonstrate the triple combination of beclometasone dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality of life in COPD patients (Chronic Obstructive Pulmonary Disease).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Saint George's Respiratory Questionnaire (SGRQ) total score at Week 26.

  the primary efficacy variable is the numeric value of the change

  26 weeks

Secondary Outcomes (2)

• SGRQ response (change from baseline in total score ≤ -4) at Week 26.

  26 weeks

• rced expiratory volume at one second (FEV1) response (change from baseline in pre-dose morning FEV1 ≥ 100 ml) at Week 26.

  26 weeks

Study Arms (2)

BDP/FF/GB

EXPERIMENTAL

Drug: BDP/FF/GB Other name: CHF 5993 pMDI 100/6/12 mcg

Drug: BDP/FF/GB

FlF/VI + Tiotropium

ACTIVE COMPARATOR

FlF/VI + Tiotropium Other name: Relvar DPI 100/25 mcg + Spiriva 18 mcg capsule

Drug: FlF/VI + Tiotropium

Interventions

BDP/FF/GB DRUG

BDP/FF/GB

FlF/VI + Tiotropium DRUG

FlF/VI + Tiotropium

Eligibility Criteria

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

You may qualify if:

• Male and female adults aged ≥ 40 years with written informed consent obtained prior to any study-related procedure.
• Patients with a diagnosis of COPD at least 12 months before the screening visit (according to GOLD document updated 2014).
• Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years \[pack-years = (number of cigarettes per day x number of years)/20\].
• A post-bronchodilator FEV1 \< 50% of the predicted normal value and a post-bronchodilator forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) \< 0.7 at least 10-15 min after 4 puffs (4 x 100 μg) of salbutamol pMDI. If this criterion is not met at screening, the test can be repeated once before randomisation.
• A documented history of at least one exacerbation in the 12 months preceding the screening visit.
• COPD exacerbation will be defined according to the following:
• "A sustained worsening of the patient's condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids and/or antibiotics or need for hospitalization". Also documented visits to an emergency department due to COPD exacerbation are considered acceptable to fulfil this criterion.
• Patients under double therapy for at least 2 months prior to screening visit with either:
• inhaled corticosteroids/long-acting β2-agonist combination (fixed or free), without regular use of short-acting muscarinic antagonist (regular use means 2 puffs 4 times per day at least) or
• inhaled corticosteroids/long-acting muscarinic antagonist free combination, without regular use of short-acting β2-agonist (regular use means 2 puffs 4 times per day at least) or
• Inhaled long-acting β2-agonist and inhaled long-acting muscarinic antagonist or
• Patients under monotherapy with long-acting muscarinic antagonist for at least 2 months prior to screening.
• Symptomatic patients at screening with a CAT score ≥10.
• A cooperative attitude and ability to use correctly the inhalers.
• A cooperative attitude and ability to use correctly the daily electronic Diary (eDiary).

You may not qualify if:

• Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more methods of contraception as defined in the protocol
• Patients with a current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy
• Patients requiring use of the following medications:
• A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening
• A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening
• phosphodiesterase-4 (PDE4) inhibitors in the 4 weeks prior to screening
• Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) in the 4 weeks prior to screening
• COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period
• Patients treated with non-cardio selective β-blockers in the month preceding the screening visit or during the run-in period. Those patients may enter the study after non-selective β-blockers withdrawal and/or cardio selective β-blockers intake for at least 10 days before randomization
• Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as o re nata (PRN).
• Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
• Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator's judgment
• Patients who have clinically significant cardiovascular condition
• Patients with atrial fibrillation (AF):
• Paroxysmal Atrial Fibrillation

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Erzsebet Gondozohaz

Gödöllő, 2100, Hungary

Location

Related Links

• Study Record on EU Clinical Trials Register including results
• CSR Synopsis available in the CHIESI Clinical Study Register

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 10, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Locations

HU (1)