EVALUATION OF CARDIAC SAFETY, TOLERABILITY AND EFFICACY OF CUMULATIVE DOSES OF CHF5188 pMDI (FIXED COMBINATION BUDESONIDE/CARMOTEROL 200/1 µg) COMPARED TO SAME CUMULATIVE DOSES OF CARMOTEROL pMDI AND PLACEBO IN ASTHMATIC PATIENTSA MONOCENTER, RANDOMISED, DOUBLE-BLIND, 3-WAY, CROSS-OVER CLINICAL STUDY

• Conditions: Stable persistent asthma; MedDRA version: 13.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2007-000774-23-GB
• Lead Sponsor: Chiesi Farmaceutici S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

·Written informed consent obtained;
·Male or female patients aged = 18 and < 70 years;
·Patients with a clinical diagnosis of persistent asthma according to the GINA 2005 Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment”;
·Patients already treated with inhaled corticosteroids at a stable dose for at least 4 weeks prior to inclusion;
.Patients with 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;
·Patients with a documented positive response to the reversibility test, defined as ?FEV1 = 15% and = 200 mL over baseline, 30 minutes after 200 µg salbutamol pMDI;
·Patients with normal blood pressure (i.e. supine SBP = 140 mmHg, supine DBP = 90 mmHg);
·Patients with normal ECG with heart rate < 100 bpm and QTcB interval = 450msec for males and = 470msec for females;
·Patients with a co-operative attitude and ability to be trained to correctly use the pMDI.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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;
·Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks (e.g. oral corticosteroids intake);
·Patients presenting with 3 or more asthma exacerbations in the previous year;
·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, long-acting ß2-agonists in the past 48 hours, short-acting anticholinergics in the past 12 hours, long-acting anticholinergics (i.e. tiotropium bromide) in the past 48 hours, leukotriene antagonists in the past 2 weeks;
·Patients treated with Duovent® and Berodual® in the past 12 hours;
·Patients treated with an inhaled combination drug (eg Seretide®, Symbicort®) in the past 48 hours;
·Patients who have changed their dose or formulation of inhaled corticosteroids during the previous 4 weeks;
·History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease;
·Patients presenting with a clinically significant abnormality at a 12-lead ECG;
·Patients presenting with serum potassium < 3.5 mmol/L or > 6.0 mmol/L;
·Patients presenting with fasting blood glucose > 8 mmol/L;
·Clinically significant or unstable concomitant disease,
·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. A pregnancy test will be performed at screening in women of childbearing potential;
·History of alcohol or drug abuse;
·Allergy, sensitivity or intolerance to beta2-aderenergic 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
Main Objective: To establish the cardiac safety (QTcB interval) and the efficacy (FEV1) of cumulative-doses of CHF 5188.;Secondary Objective: To evaluate the safety and tolerability of CHF 5188 given in cumulative doses.;Primary end point(s): ·QTcB interval (change from pre-dose to 6 hours after the last cumulative dose) <br>·FEV1 (% change from pre-dose to 120 min after the last cumulative dose).