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 enrollmentFebruary 28, 2007

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

DrugsFORADIL

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Persistent asthma
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 240
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 28, 2007

End Date

TBD

Last Updated

9 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;