Back to resultsEfficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
CHF1535 200/6 µg
BDP 100 µg
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Adults, not adequately controlled, pre-dose morning PEF
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).
Sites / Locations
- Cardio-Thoracic and Vascular Dept, University of Pisa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHF 1535 200/6µg
BDP 100µg
Arm Description
Outcomes
Primary Outcome Measures
Pre-dose morning PEF
Change from baseline to the entire treatment period in average pre-dose morning PEF
Secondary Outcome Measures
Pre-dose morning FEV1
Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period
Asthma symptoms
Asthma symptoms collected day and night-time
Adverse Events
Adverse Events
Full Information
NCT ID
NCT01577082
First Posted
April 6, 2012
Last Updated
October 28, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01577082
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Adults, not adequately controlled, pre-dose morning PEF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
542 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHF 1535 200/6µg
Arm Type
Experimental
Arm Title
BDP 100µg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CHF1535 200/6 µg
Intervention Description
CHF 1535 (BDP/FF) 800/24 µg daily during 12 weeks
Intervention Type
Drug
Intervention Name(s)
BDP 100 µg
Other Intervention Name(s)
Qvar
Intervention Description
Beclomethasone Dipropionate 800µg daily during 12 weeks
Primary Outcome Measure Information:
Title
Pre-dose morning PEF
Description
Change from baseline to the entire treatment period in average pre-dose morning PEF
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pre-dose morning FEV1
Description
Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period
Time Frame
2 weeks
Title
Asthma symptoms
Description
Asthma symptoms collected day and night-time
Time Frame
12 weeks
Title
Adverse Events
Description
Adverse Events
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierluigi Paggiaro, MD, PhD
Organizational Affiliation
Cardio-Thoracic and Vascular Dept, University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardio-Thoracic and Vascular Dept, University of Pisa
City
Pisa
ZIP/Postal Code
56124
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
27938358
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.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-020602-14
Description
Study Record on EU Clinical Trials Register including results
URL
https://www.chiesi.com/clinic/CSR_Synopsis_CCD-1005-PR-0040.pdf
Description
CSR Synopsis available in the CHIESI Clinical Study Register
Learn more about this trial
Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
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