Moderate persistent asthma sub optimally controlled on existing therapy. MedDRA version: 8 Level: PT Classification code 10003553
Conditions
Interventions
Product Name: CHF 4226 HFA pMDI
Product Code: CHF 4226 HFA
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Carmoterol hydrochloride
CAS Number: 137888-11-0
Current Sponsor
Sponsors
CHIESI Farmaceutici S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled at Visit 1 into the run-in period if they meet all of the following criteria: Written informed consent obtained; Male or female patients aged > or equal to 18 years; Moderate persistent asthma according to the GINA 2004 “Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment”, sub-optimally controlled on existing therapy; Patients free of long-acting beta2 agonists treatment (LABAs) at least for 4 weeks before the screening visit and already treated for at least 1 month with inhaled corticosteroids at a stable dose corresponding to mild asthma severity (GINA 2004) (up to 500µg BDP CFC or equivalent); Asthma not adequately controlled on existing therapy, defined as presence of asthma symptoms > once a week and nocturnal asthma symptoms > twice a month. These findings are to be confirmed at the end of the run-in period, taking into consideration the patient's recent medical history; Forced expiratory volume in the first second (FEV1) > or equal to 60% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be enrolled at Visit 1 into the run-in period if they meet one or more of the following criteria: Inability to carry out pulmonary function testing; Diagnosis of COPD as defined by the current GOLD guidelines; History of near fatal asthma; History of significant seasonal variation of asthma; Asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks or during the run-in period (e.g. oral corticosteroids intake, antibiotics); Patients presenting with 3 or more asthma exacerbations in the previous 6 months; Hospitalization due to asthma during the previous 8 weeks; Patients who have been treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks or during the run-in period; Patients who have changed their dose or formulation of their inhaled corticosteroids during the previous 4 weeks or during the run-in period; Patients who have been treated with a short-acting ß2-agonist in the past 8 hours; Patients who have been treated with an oral ß2-agonist in the past 4 weeks; Patients who have been treated with nebulized ß2-agonists, nebulized corticosteroids, inhaled anticholinergics, leukotriene modifiers, xanthine derivatives (e.g. theophylline any formulation) in the past 4 weeks or during the run-in period; Patients who have been treated with sodium cromoglycate or nedocromil sodium in the past 12 hours or during the run-in period; Patients who have been treated with an inhaled combination drug (eg Seretide®, Symbicort®, Duovent®, Berodual®) in the past 4 weeks or during the run-in period; History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease; Patients with a QTc interval (Bazett’s formula) in the ECG test > 450 msec in males or > 470 msec in females; Patients with serum potassium 6.0mEq/L; Clinically significant or unstable concomitant disease : e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant pulmonary disease (e.g. tuberculosis, lung cancer or other); gastrointestinal disease (e.g. active peptic ulcer or other); neurological disease; haematological disease; autoimmune disorders or other; Cancer or any other chronic disease with poor prognosis and /or affecting patient status; Pregnant or lactating females or females at risk of pregnancy, who are not making use of an effective contraceptive method. A pregnancy test will be performed at screening in women of childbearing potential; Patients who have been treated with monoamine oxidase inhibitors, tricyclic antidepressants, Selective Serotonin Re Uptake Inhibitors (SSRIs), long-acting antihistamines or beta-blockers in the past 48 hours or during the run-in period (if the patient is on a short acting antihistamine or SSRI treatment, she/he can be included in the study under the following 2 conditions : (i) a recent ECG while patient was on therapy with these medications demonstrate that the QTc interval is in normal range;(ii) these therapies are taken in an unchanged dose throughout the duration of the study); Allergy, sensitivity or intolerance to study drug formulation or excipients; Patients unlikely to comply with the protocol or unable to understand the nature, scope of the study but also the possible benefits or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To demonstrate the non inferiority in terms of morning PEF of the "free combination" of CHF 4226 HFA pMDI + extrafine budesonide HFA pMDI given once daily in the evening (2µg + 200µg qd) versus CHF 4226 HFA pMDI + extrafine budesonide HFA pMDI given twice daily (1µg + 100µg bid). ;Secondary Objective: Secondary: To demonstrate the superiority of both "free combination" regimens over the Inhaled CorticoSteroid [ICS] monotherapy [Budesonide Turbuhaler]; Evaluation of the other lung function endpoints (FEV1, FCV, FEF25-75), effect on asthma symptoms, rescue salbutamol use; To monitor for safety and tolerability.;Primary end point(s): Primary variables: Morning PEF (L/min) measured daily with the electronic peak flow meter (mean of at least 7 values obtained during the last 14 days of the treatment period). Secondary variables: Morning and evening PEF (L/min) measured with the electronic peak flow meter in the last 14 days before each clinic visit; FEV1 (L) , FVC (L), FEF25-75 (L/s) measured at clinic at each visit; Day and night asthma symptoms scores; Percentage of nights and / or days free of symptoms; Salbutamol rescue use; Asthma control. | — |
Countries
Hungary
Outcome results
None listed