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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01577082
First received: April 6, 2012
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period

  • Asthma symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Asthma symptoms collected day and night-time

  • Adverse Events [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577082

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

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01577082     History of Changes
Other Study ID Numbers: CCD-1005-PR-0040, 2010-020602-14
Study First Received: April 6, 2012
Last Updated: July 29, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: National Institute of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 15, 2014