Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
NCT ID: NCT01577082
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
542 participants
INTERVENTIONAL
2012-04-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CHF 1535 200/6µg
CHF1535 200/6 µg
CHF 1535 (BDP/FF) 800/24 µg daily during 12 weeks
BDP 100µg
BDP 100 µg
Beclomethasone Dipropionate 800µg daily during 12 weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Pierluigi Paggiaro, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardio-Thoracic and Vascular Dept, University of Pisa
Locations
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Cardio-Thoracic and Vascular Dept, University of Pisa
Pisa, , Italy
Countries
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References
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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.
Related Links
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Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
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2010-020602-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-1005-PR-0040
Identifier Type: -
Identifier Source: org_study_id