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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577082
• Other study ID #: CCD-1005-PR-0040
• Secondary ID: 2010-020602-14
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?FEV1 >= 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).

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF1535 200/6 µg
CHF 1535 (BDP/FF) 800/24 µg daily during 12 weeks
• BDP 100 µg
Beclomethasone Dipropionate 800µg daily during 12 weeks

Locations

Country	Name	City	State
Italy	Cardio-Thoracic and Vascular Dept, University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 µg) is effective in asthma patients not adequately controlled on medium-high dose of inhale — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-dose morning PEF	Change from baseline to the entire treatment period in average pre-dose morning PEF	12 weeks
Secondary	Pre-dose morning FEV1	Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period	2 weeks
Secondary	Asthma symptoms	Asthma symptoms collected day and night-time	12 weeks
Secondary	Adverse Events	Adverse Events	14 weeks

External Links

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