EVALUATION OF THE EFFECT OF 4 WEEKS TREATMENT WITH CHF 4226 pMDI 2µg DOSE GIVEN ONCE DAILY IN THE EVENING ON 24-HOUR TROUGH FEV1 IN ADULT AND ADOLESCENT PATIENTS AGED 15 YEARS OR OVER WITH MODERATE OR SEVERE PERSISTANT ASTHMA.A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PARALLEL GROUP, PLACEBO AND ACTIVE (FORMOTEROL 12µg B.I.D.) CONTROLLED, EFFICACY, SAFETY AND TOLERABILITY STUDY.
- Conditions
- Persistent asthmaMedDRA version: 8.1Level: PTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2006-005689-38-HU
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
Patients will be enrolled at Visit 1 into the run-in period if they meet all the following criteria:
·Written informed consent obtained;
·Male or female patients aged 15 years and over;
·Moderate or severe persistent asthma according to the GINA 2005 Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment”;
·Patients free of long-acting ß2 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-medium asthma severity (GINA 2005) (up to 1000 µg BDP CFC or equivalent);
·Level of asthma control on existing therapy, defined as presence of day-time asthma symptoms > once a week and nocturnal asthma symptoms > twice a month. These findings are to be based on recent medical history and are to be confirmed at the end of the run-in period;
·Forced expiratory volume in the first second (FEV1) less or equal to 90% of predicted for the patient normal value and not less than 0.9 L in absolute value;
·Positive response to the reversibility test in the screening visit, defined as an increase of at least 12% and at least 250 mL from pre-dosing value in the measurement of FEV1 30 minutes following 2 puffs (2 x 100 µg) of inhaled salbutamol pMDI;
·Non-smokers or ex-smokers < 5 pack-year [e.g. less than 1 pack cigarettes (i.e. 20 cigarettes) per day for 5 years or 2 packs cigarettes per day for 2.5 years] and having stopped smoking > 1 year;
·A co-operative attitude and ability to be trained to correctly use the pMDI and the Aerolizer® inhaler;
·At the end of the run-in period, the presence of day-time asthma symptoms > once a week (but not every day) and nocturnal asthma symptoms > twice a month is to be confirmed by means of patient interview by the investigator.
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
Patients will not be enrolled at Visit 1 into the run-in period if they meet any of the following criteria:
·Inability to carry out pulmonary function testing;
·Diagnosis of COPD as defined by the current GOLD guidelines;
·Current smoker or ex-smoker with total cumulative exposure equal or more than 5 pack-years and/or having stopped smoking one year or less prior to study start;
·History of near fatal asthma or of a past hospitalisation for asthma in an intensive care unit;
·History of significant seasonal variation of asthma;
·Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks (e.g. oral corticosteroids intake);
·Hospitalisation due to asthma during the previous 8 weeks;
·Patients treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks;
·Patients treated with short-acting ß2-agonists in the past 8 hours, short-acting anticholinergics in the past 12 hours, long-acting anticholinergics (i.e. tiotropium bromide) in the past 48 hours, leukotriene modifiers in the past 2 weeks;
·Patients treated with oral or nebulized bronchodilators in the 4 weeks prior to study start;
·Patients treated with nebulized corticosteroids in the 4 weeks prior to study start;
·Patients who have changed their dose or formulation of inhaled or nasal corticosteroids during the previous 4 weeks;
·Patients treated with fixed combination of inhaled corticosteroids and ß2-agonists (e.g. Seretide®, Symbicort®) during the previous 4 weeks prior to study start;
·Patients undergoing immunotherapy;
·Patients treated with a xanthine derivative (e.g. theophylline) any formulation in the 4 weeks prior to study start;
·Patients treated with sodium cromoglycate or nedocromil sodium in the 4 weeks prior to study start;
·History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiac disease;
·Patients with a QTc interval (Bazett’s formula) in the ECG test > 450 msec in males or > 470 msec in females;
·Serum potassium < 3.5 mmol/L or > 6.0mmol/L;
·Clinically significant or unstable concurrent disease, e.g. uncontrolled diabetes mellitus; uncontrolled hyperthyroidism, significant hepatic impairment, significant pulmonary disease other than asthma (e.g. tuberculosis, lung cancer), gastrointestinal disease (e.g. active peptic ulcer), neurological or haematological autoimmune disorders;
·Cancer or any other chronic disease with poor prognosis and/or affecting patient status;
·Pregnant or lactating females or females at risk of pregnancy, i.e. those not making use of an effective contraceptive method (oral contraception, IUD, tubal ligature, double barrier method). A pregnancy test will be performed at screening in women of childbearing potential;
·History of alcohol or drug abuse;
·Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers;
·Allergy, sensitivity or intolerance to beta2-adrenergic agonists and/or study drug formulation ingredients;
·Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
·Patients who received any investigational new drug within the last 8 weeks.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method