Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients

A 12-week, Multinational, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of CHF 1535 200/6µg Versus Beclomethasone Dipropionate in Adult Asthmatic Patients Not Adequately Controlled on High Dose of Inhaled Corticosteroids or on Medium Dose of Inhaled Corticosteroids Plus Long-acting β2 Agonists

The purpose of this study is to show the superiority of CHF 1535 (BDP/FF) pMDI over BDP HFA pMDI in terms of lung function considering change from baseline to the entire treatment period in average pre-dose morning PEF in adult asthmatic patients not adequately controlled on high doses of ICS or on medium dose of ICS+LABA.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: CHF1535 200/6 µg; Drug: BDP 100 µg

• Study Type: Interventional
• Enrollment (Actual): 542
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56124
    • Cardio-Thoracic and Vascular Dept, University of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• Male or female patients aged > 18 years.
• Patients with persistent asthma not optimally controlled (GINA 2010) on high doses of ICS or medium dose of ICS+LABA at a stable dose for at least 4 weeks prior to screening.
• Patients with FEV1 >= 40% and < 80% of predicted for the patient normal value and at least 0.9 L.
• Patients with a documented positive response to the reversibility test, defined as ΔFEV1 >= 12% and >= 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI.
• At screening and at the end of the run-in period, patients with not adequately controlled asthma according to GINA 2010 and with score at the Asthma Control Questionnaire (ACQ)> 0.75

Main Exclusion Criteria:

• History of near fatal asthma or of a past hospitalisation for asthma in Intensive Care Unit or of frequent exacerbations (3 or more asthma exacerbations/ year).
• Hospitalisation, Emergency Room admission or use of systemic steroids (more than 3 days) for asthma exacerbation in the 4 weeks prior to screening visit and during the run-in period.
• Symptomatic infection of the lower airways in the 4 weeks before the screening visit.
• Current or ex-smokers with total cumulative exposure equal or more than 5 pack-years and /or having stopped smoking one year or less prior to screening visit.
• Patients with a clinically significant abnormality at 12-lead ECG or presenting a QTcB interval value in ECG > 450 msec in males or > 470 msec in females).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF 1535 200/6µg	Drug: CHF1535 200/6 µg; CHF 1535 (BDP/FF) 800/24 µg daily during 12 weeks
Active Comparator: BDP 100µg	Drug: BDP 100 µg; Beclomethasone Dipropionate 800µg daily during 12 weeks; Other Names: Qvar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-dose morning PEF	Change from baseline to the entire treatment period in average pre-dose morning PEF	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-dose morning FEV1	Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period	2 weeks
Asthma symptoms	Asthma symptoms collected day and night-time	12 weeks
Adverse Events	Adverse Events	14 weeks

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Pierluigi Paggiaro, MD, PhD, Cardio-Thoracic and Vascular Dept, University of Pisa

Publications and helpful links

General Publications

• Paggiaro P, Corradi M, Latorre M, Raptis H, Muraro A, Gessner C, Siergiejko Z, Scuri M, Petruzzelli S. High strength extrafine pMDI beclometasone/formoterol (200/6 mug) is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroids. BMC Pulm Med. 2016 Dec 9;16(1):180. doi: 10.1186/s12890-016-0335-9.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 6, 2012
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (Estimate): April 13, 2012

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Adults, not adequately controlled, pre-dose morning PEF
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CCD-1005-PR-0040; 2010-020602-14 (EudraCT Number)