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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: CHF1535 200/6 µg; Drug: BDP 100 µg

• Registration Number: NCT01577082
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 542

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF 1535 200/6µg	CHF1535 200/6 µg	-
BDP 100µg	BDP 100 µg	-

Primary Outcome Measures

Name	Time	Method
Pre-dose morning PEF	12 weeks	Change from baseline to the entire treatment period in average pre-dose morning PEF

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardio-Thoracic and Vascular Dept, University of Pisa; 🇮🇹 Pisa, Italy