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

This study has been completed.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A. Identifier:
First received: April 6, 2012
Last updated: March 28, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Asthma Drug: CHF1535 200/6 µg Drug: BDP 100 µg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Pre-dose morning PEF [ Time Frame: 12 weeks ]
    Change from baseline to the entire treatment period in average pre-dose morning PEF

Secondary Outcome Measures:
  • Pre-dose morning FEV1 [ Time Frame: 2 weeks ]
    Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period

  • Asthma symptoms [ Time Frame: 12 weeks ]
    Asthma symptoms collected day and night-time

  • Adverse Events [ Time Frame: 14 weeks ]
    Adverse Events

Enrollment: 542
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF 1535 200/6µg Drug: CHF1535 200/6 µg
CHF 1535 (BDP/FF) 800/24 µg daily during 12 weeks
Active Comparator: BDP 100µg Drug: BDP 100 µg
Beclomethasone Dipropionate 800µg daily during 12 weeks
Other Name: Qvar


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01577082

Cardio-Thoracic and Vascular Dept, University of Pisa
Pisa, Italy, 56124
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Principal Investigator: Pierluigi Paggiaro, MD, PhD Cardio-Thoracic and Vascular Dept, University of Pisa
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT01577082     History of Changes
Other Study ID Numbers: CCD-1005-PR-0040
2010-020602-14 ( EudraCT Number )
Study First Received: April 6, 2012
Last Updated: March 28, 2017

Keywords provided by Chiesi Farmaceutici S.p.A.:
Adults, not adequately controlled, pre-dose morning PEF

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents processed this record on August 22, 2017