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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01577082
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 542 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Pre-dose morning FEV1 [ Time Frame: 2 weeks ]
    Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period

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

  3. Adverse Events [ Time Frame: 14 weeks ]
    Adverse Events

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 )
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 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