Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
This study is currently recruiting participants.
Verified June 2012 by Chiesi Farmaceutici S.p.A.
Sponsor:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01577082
First received: April 6, 2012
Last updated: June 18, 2012
Last verified: June 2012
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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
| Estimated Enrollment: | 540 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | March 2013 (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
Contacts
| Contact: Marissa Minetti | + 39 0521 279 715 | M.Minetti@chiesigroup.com |
| Contact: Helene Raptis | + 33 1 47 68 41 45 | h.raptis@chiesifrance.com |
Locations
| Italy | |
| Cardio-Thoracic and Vascular Dept, University of Pisa | Recruiting |
| Pisa, Italy, 56124 | |
| Contact: Pierluigi Paggiaro, MD, PhD +39050995366 lpaggiaro@dcap.med.unipi.it | |
| Principal Investigator: Pierluigi Paggiaro, MD, PhD | |
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: | June 18, 2012 |
| 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 May 19, 2013