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COMPLETEDPHASE3

2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients

52-week, Double Blind, Randomized, 2 Active Parallel Arms Study of Fixed Combination CHF 5993 Administered vs Ultibro® in COPD Patients

NCT02579850•Chiesi Farmaceutici S.p.A.

View on ClinicalTrials.gov

Summary

The aim of the present study is to evaluate the superiority of the fixed triple therapy with BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler® (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.

Detailed Description

Outpatients attending the hospital clinics/study centres will be recruited. Patients with severe and very severe COPD airflow obstruction according to GOLD 2014 criteria. A total of approximately 2192 patients will need to be screened in order to obtain 1534 (767 per arm) randomized and evaluable patients. Approximately 200 sites will be involved worldwide. Each patient will perform a total of 8 clinic visits (V0 to V7) during the study. The Primary objective is to demonstrate the superiority of CHF 5993 pMDI over Ultibro® in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment. The Secondary objectives are: 1. To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures; 2. To assess the safety and the tolerability of the study treatments. A 2-week open-label run-in period under Ultibro® followed by a 52-week randomised treatment period. The trial design will be optimised to measure exacerbation rates by using the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), developed means of collecting patient-reported outcome (PRO) data, which helps to capture the frequency of exacerbations.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inclusion :
•1. Male and female ≥ 40 years
•2. Severe or very severe COPD diagnosed for at least 12 months
•3. 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
•4. Post-bronchodilator FEV1 \< 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio \< 0.7
•5. Documented history of at least one exacerbation in the 12 months
•6. Patient under double therapy for at least 2 months prior to screening. Double therapy will be defined by treatment with any of the following:
•Orally inhaled corticosteroid (ICS) and (long-acting beta2-agonist) LABA ICS and long-acting muscarinic antagonist (LAMA) Orally LABA and LAMA Monotherapy with LAMA for at least 2 months prior to screening
•7. Symptomatic patient at screening with a CAT score ≥ 10.
•8. Cooperative attitude and ability to use correctly the inhalers, the spacer AeroChamber Plus (only to patients who are using a spacer), the electronic devices with COPD questionnaire.
+13 more criteria

Exclusion Criteria

•13. Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction would prevent use of anticholinergic agents
•14. History of hypersensitivity to M3 Antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug
•15. Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug
•16. Patients with hypokalaemia (serum potassium \<3.5 mEq/L or 3.5 mmol/L) or uncontrolled hyperkalaemia
•17. Unstable concurrent disease which may impact the results of the study
•18. Patients with any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next six months (after V1) or with malignancy for which they are currently undergoing radiation therapy or chemotherapy
•19. History of alcohol abuse or substance/drug abuse within 12 months prior to screening visit
•20. Participation in another clinical trial if investigational drug was received less than 8 weeks prior to screening visit

Locations (1)

Chiesi Farmaceutici S.p.A.

Parma, Italy

Key Dates

Start Date

May 29, 2015

Primary Completion Date

July 10, 2017

Completion Date

July 10, 2017

Last Updated

October 29, 2021

Enrollment

1,532

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

CHF 5993 + Ultibro matched placebo

DRUG

Ultibro + CHF 5993 matched placebo

DRUG

Central spirometry

PROCEDURE

COPD assessment test

OTHER

Local laboratory Assessments

PROCEDURE

Saint George's Respiratory Questionnaire

OTHER

EXACT-pro questionnaire

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients

Inclusion Criteria

Exclusion Criteria

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A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A