Clinical trial NCT01577082: Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Adults, not adequately controlled, pre-dose morning PEF
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Pre-dose morning PEF
timeFrame: 12 weeks
Secondary outcomes:
measure: Pre-dose morning FEV1
timeFrame: 2 weeks
measure: Asthma symptoms
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Cardio-Thoracic and Vascular Dept, University of Pisa
Study officials:
affiliation: Cardio-Thoracic and Vascular Dept, University of Pisa
name: Pierluigi Paggiaro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.