A 48-week, multicentre, multinational, randomized, double-blind, 2-arm parallel group study, comparing the efficacy of FOSTERTM for maintenance and reliever versus fixed-dose FOSTERTM for maintenance + salbutamol as reliever in asthmatics >12 years of age - ND
- Conditions
- not fully controlled asthmatics.MedDRA version: 9.1Level: HLTClassification code 10024966Term: Congenital lower respiratory tract disorders
- Registration Number
- EUCTR2008-004671-22-IT
- Lead Sponsor
- CHIESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2482
1.Written signed and dated informed consent obtained 2.Male or female patients aged ≥ 18 years.3.Clinical diagnosis of asthma for ≥ 6 months. 4.A positive reversibility test 5.Patients who experienced at least one severe exacerbation in the 12 months before entry 6.Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose 7.Not fully controlled asthmatics 8.Forced expiratory volume in the first second (FEV1) ≥ 60% of predicted for the patient normal value. 9.Non smokers or ex-smokers 10. A co-operative attitude and ability to be trained to correctly use the pMDI. 11.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Pregnant or nursing women 2.Body Mass Index (BMI) > 34 kg/m2. 3.Patient with lower respiratory tract infections affecting the patient?s asthma within 30 days of the screening visit.4.Use of systemic steroids in the last month.5.Patients with other lung diseases 6.Patients who have an uncontrolled respiratory, 7.History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias. 8.Cancer or any other chronic disease with poor prognosis 9.Clinically relevant laboratory abnormalities 10.Patients who have an abnormal QTcF interval value in the screening visit ECG test 11.Intolerance or contra-indication to treatment with 2-agonists and/or ICS 12. Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.13.Patients unlikely to comply with the study14.Patients being treated with anti-IgE antibodies.15.Patients treated with LABA or ICS/LABA fixed combination in the 24h before Visit 1.
16.Patient having received an investigational drug within 2 months before the screening visit.
17.Inability to comply to study procedures or to study treatment intake.
18.Inability to carry out a valid spirometry.
19.Severe asthma exacerbation in the last month before screening visit
20.Severe asthma exacerbation during the run-in period (to be checked at V2).
Exclusion criterion 20, will be checked at Visit 2 and no use of a non-permitted concomitant medication must have taken place during the run-in period for the patient to be eligible for randomization in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Time to first severe asthma exacerbation. Severe exacerbations will be defined as deterioration in asthma resulting in hospitalisation or emergency room treatment due to asthma worsening, or the need for systemic steroids for ≥ 3 days because of asthma.;Main Objective: To compare the efficacy of FOSTERTM 100/6 µg, one inhalation bid as maintenance therapy plus additional inhalations as reliever [MART approach], with FOSTERTM 100/6 µg, (one inhalation bid as maintenance therapy) plus salbutamol (100 µg/inhalation) as reliever in not fully controlled asthmatics.;Secondary Objective: To evaluate the effect of the therapy on lung function parameters, on other clinical outcome measures, and to assess the safety and the tolerability of FOSTERTM as both maintainance and reliever therapy.
- Secondary Outcome Measures
Name Time Method