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.

Chiesi Farmaceutici S.p.A.0 sites240 target enrollmentJanuary 3, 2007

ConditionsPersistent asthma MedDRA version: 8.1Level: PTClassification code 10003553Term: Asthma

DrugsFORADIL

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Persistent asthma
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 240
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

January 3, 2007

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 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;

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 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;