EVALUATION OF THE EFFICACY, SAFETY AND TOLERABILITY OF THE CONCURRENT ADMINISTRATION OF CHF 4226 HFA pMDI AND EXTRAFINE BUDESONIDE HFA pMDI, BOTH GIVEN ONCE OR TWICE DAILY (2µg + 200µg qd or 1µg + 100µg bid) OVER AN 8-WEEK RANDOMIZED DOUBLE-BLIND TREATMENT PERIOD IN ADULT PATIENTS WITH MODERATE PERSISTENT ASTHMA AND PRESENTING WITH SYMPTOMS ON EXISTING INHALED CORTICOSTEROID THERAPY.

• Conditions: Moderate persistent asthma sub optimally controlled on existing therapy.; MedDRA version: 8Level: PTClassification code 10003553

• Registration Number: EUCTR2006-000038-11-HU
• Lead Sponsor: CHIESI Farmaceutici S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 304

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 < 80% of predicted for the patient normal value;

Positive FEV1 reversibility test at the screening visit, defined as an increase of at least 15% and at least 200 mL from pre-dose value in FEV1 30 minutes following 4 puffs (4 x 100 µg) of inhaled salbutamol pMDI;

A documented FEV1 positive reversibility test as above, is acceptable if performed within 6 months of the screening visit ;

Non-smokers or ex-smokers with cumulative tobacco exposure < 5 pack-years [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 who have stopped smoking for at least 1 year;

A co-operative attitude and ability to be trained to correctly use the pMDI and Turbuhaler®.

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 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 < 3.5mEq/L or > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified