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Active Controlled Trial of CH...

Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)

NCT ID: NCT03197818

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

990 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-14

Study Completion Date

2020-05-26

Brief Summary

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The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.

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Detailed Description

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Conditions

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COPD (Chronic Obstructive Pulmonary Disease)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF 5993 100/6/12.5 µg

Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide)

Group Type EXPERIMENTAL

CHF 5993 100/6/12.5 µg

Intervention Type DRUG

Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose

Symbicort Turbuhaler 160/4.5 µg

Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate)

Group Type ACTIVE_COMPARATOR

160 µg budesonide + 4.5 µg formoterol fumarate

Intervention Type DRUG

Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg

Interventions

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CHF 5993 100/6/12.5 µg

Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose

Intervention Type DRUG

160 µg budesonide + 4.5 µg formoterol fumarate

Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or Female adults aged \> 40 years with a diagnosis of COPD
* Current smokers or ex-smokers
* A post-bronchodilator FEV1 \< 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio \< 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI
* At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria

* Pregnant or lactating women
* Diagnosis of asthma, history of allergic rhinitis or atopy
* Patients treated for exacerbations in the 4 weeks prior to screening visit
* Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit
* 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 Pro Re Nata
* Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia
* Known respiratory disorders other than COPD
* Patients who have clinically significant cardiovascular condition

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinping Zheng

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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Chiesi clinical Trial Site 156031

Beijing, Beijing Municipality, China

Site Status

Chiesi Clinical Trial Site 156026

Beijing, Beijing Municipality, China

Site Status

Chiesi clinical Trial Site 156017

Beijing, Beijing Municipality, China

Site Status

Chiesi Clinical Trial Site 156012

Beijing, Beijing Municipality, China

Site Status

Chiesi Clinical Trial Site 156045

Chongqing, Chongqing Municipality, China

Site Status

Chiesi Clinical Trial Site 156002

Fuzhou, Fujian, China

Site Status

Chiesi clinical Trial Site 156024

Foshan, Guangdong, China

Site Status

Chiesi Clinical Trial Site 156048

Guangzhou, Guangdong, China

Site Status

Chiesi Clinical Trial Site 156013

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Guangzhou Medical University site 156001

Guanzhou, Guangdong, China

Site Status

Chiesi Clinical Trial Site 156008

Zhanjiang, Guangdong, China

Site Status

Chiesi Clinical Trial site 156003

Nanning, Guangxi, China

Site Status

Chiesi clinical Trial Site 156020

Haikou, Hainan, China

Site Status

Chiesi Clinical Trial Site 156044

Shijiangzhuang, Hebei, China

Site Status

Chiesi Clinical Trial Site 156040

Changsha, Hunan, China

Site Status

Chiesi Clinical Trial Site 156040

Changsha, Hunan, China

Site Status

Chiesi Clinical Trial Site 156043

Baotou, Inner Mongolia, China

Site Status

Chiesi Clinical Trial Site 156015

Baotou, Inner Mongolia, China

Site Status

Chiesi Clinical Trial Site 156004

Huai'an, Jiangsu, China

Site Status

Chiesi clinical Trial Site 156033

Jiangyin, Jiangsu, China

Site Status

Chiesi clinical Trial Site 156022

Nanjing, Jiangsu, China

Site Status

Chiesi Clinical Trial Site 156049

Suzhou, Jiangsu, China

Site Status

Chiesi Clinical Trial Site 156047

Jiujiang, Jiangxi, China

Site Status

Chiesi Clinical Trial Site 156041

Nanchang, Jiangxi, China

Site Status

Chiesi clinical Trial Site 156028

Nanchang, Jiangxi, China

Site Status

Chiesi Clinical Trial Site 156042

Pingxiang, Jiangxi, China

Site Status

Chiesi clinical Trial Site 156023

Changchun, Jilin, China

Site Status

Chiesi Clinical Trial Site 156036

Changchun, Jilin, China

Site Status

Chiesi clinical Trial Site 156019

Changchun, Jilin, China

Site Status

Chiesi Clinical Trial Site 156007

Shenyang, Liaoning, China

Site Status