Multinational Clinical Trial of 12 weeks of duration to test the efficacy and safety of a new drug called CHF 1535 200/6µg (fixed combination beclomethasone dipropionate / formoterol) versus beclomethasone dipropionate in adults asthmatic patients not adequately controlled on high doses of inhaled corticosteroids or on medium dose of inhaled corticosteroids plus long-acting ß2 agonists

Conditions: ADULTS ASTHMATIC PATIENTS NOT ADEQUATELY CONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS OR ON MEDIUM DOSE OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING ß2 AGONISTS
MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2010-020602-14-DE

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 378

Inclusion Criteria

1.Patient’s written informed consent obtained prior to any study-related procedures.
2.Male or female patients aged >18.
3.Patients with persistent asthma not optimally controlled (GINA 2010 ‘Management Approach Based on Control’) on high doses of ICS (1000-2000µg daily dose BDP non-extrafine or equivalent) or medium dose of ICS+LABA (500-1000µg daily dose BDP non-extrafine or equivalent plus formoterol 24 µg or salmeterol 100µg) at a stable dose for at least 4 weeks prior to screening.
4.Patients with a FEV1 =40% and <80% of patient’s predicted normal value and an absolute value of at least 0.9L, after appropriate washout from bronchodilators at screening and at the end of the run-in period.
5.Patients with a positive response to the reversibility test at screening, defined as ?FEV1 =12% and =200mL over baseline, within 30 minutes after administration of 400µg of salbutamol pMDI. In case this reversibility threshold is not met, the FEV1 reversibility test can be performed once before randomisation, after an appropriate wash-out from bronchodilators. Alternatively, a documented positive response to reversibility, as defined above, within the 3 months prior to the screening visit is acceptable.
6.Patients with not adequately controlled asthma evidenced by:
at least one of the following at any week in the 2 previous weeks (other than FEV1 <80% of the predicted normal value) must be present:
-daytime symptoms more than twice/week;
-any limitations of activities;
-nocturnal symptoms/awakening;
-need for reliever/rescue treatment more than twice/week.
and a score at the Asthma Control Questionnaire© (ACQ) >0.75.
Both of the above must be met at screening and at the end of the run-in period.
7.Presence of at least 7 available pre-dose morning PEF measurements in the run-in period.
8.Patients with a co-operative attitude and ability to be trained to correctly use the pMDI and a portable electronic peak flow meter.
9.For France only: only patients registered under a social welfare can be included in the study.

Are the trial subjects under 18? no
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 322
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1.Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake.
2.Seasonal (intermittent) asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
3.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) which, in the judgement of the investigator, may place the patient at undue risk.
4.Hospitalisation, Emergency Room admission or use of systemic corticosteroids for asthma exacerbation in the 4 weeks prior to screening visit and during the run-in period.
5.Lower Respiratory Tract Infection in the 4 weeks before the screening visit.
6.History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with data evaluation.
7.Patients who suffer from COPD as defined by the current GOLD guidelines.
8.Current smokers 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.
9.Any change in dose, schedule, formulation of ICS or ICS + LABAs in the 4 weeks prior to screening visit.
10.Patients being treated with anti-IgE antibodies.
11.Patients being treated with long acting anti-cholinergics (tiotropium).
12.Patients had used any of the following medications prior to screening visit and have not met the specified minimum wash-out period:
-short-acting ß2-agonists: 6 hours,
-long-acting ß2-agonists: 12 hours,
-fixed combinations of an anti-cholinergics and short-acting ß2-agonist: 12
hours,
-short-acting anti-cholinergic: 12 hours,
-systemic corticosteroids: 4 weeks,
-slow release corticosteroids: 12 weeks.
13.Pregnant or lactating women or women at risk of pregnancy i.e. not using one or more of the following acceptable methods of contraception:
-surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
-hormonal contraception (implantable, injectable, patch, oral)
-double-barrier methods (any double combination of: IUD, male or female
condom with spermicidal gel, diaphragm, sponge, cervical cap)
(Post-menopausal women, i.e. women with at least 12 months of natural
(spontaneous) amenorrhea or at least 6 months of spontaneous
amenorrhea with documented serum follicle-stimulating hormone (FSH)
levels >40 mIU/mL, can be enrolled).
A serum pregnancy test will be performed at screening visit in women of childbearing potential.
14.Patients who have received an investigational drug within 2 months before screening visit.
15.Patients with a significant history or current evidence of heart failure, cardiomyopathy, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease which, in the judgement of the investigator, may place the patient at undue risk.
16.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration and, in the judgment of the investigator, would make the patient inappropriate for entry into this study, place the patients at undue risk or potentially compromise the results or interpretation of the study.
17.Patients with a clinically significant abnormality at 12-lead ECG or presen

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show the superiority of CHF 1535 (BDP/FF) pMDI (800/24µg per day) over BDP HFA (Qvar®) pMDI (800µg per day) 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.;Secondary Objective: To evaluate the effect of CHF 1535 pMDI on clinical outcome measures and other lung function parameters and to evaluate the safety and tolerability profile;Primary end point(s): Change from baseline to the entire treatment period in average pre-dose morning PEF.;Timepoint(s) of evaluation of this end point: PEF performed during all study period since V2(Week0 Randomisation visit) to V8 (study end) for a total of about 12weeks

Secondary Outcome Measures