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.

CHIESI Farmaceutici S.p.A0 sites304 target enrollmentJune 7, 2006

ConditionsModerate persistent asthma sub optimally controlled on existing therapy.MedDRA version: 8Level: PTClassification code 10003553

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Moderate persistent asthma sub optimally controlled on existing therapy.
Sponsor: CHIESI Farmaceutici S.p.A
Enrollment: 304
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 7, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

CHIESI Farmaceutici S.p.A

Eligibility 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 \< 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;

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;