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 enrollmentOctober 19, 2011

ConditionsPersistent asthma MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

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: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 19, 2011

End Date

July 18, 2007

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

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; At the end of the run\-in period, the presence of day\-time asthma symptoms \> once a week (but not every day) and nocturnal asthma symptoms \> twice a month is to be confirmed by means of patient interview by the investigator.
•Are the trial subjects under 18? yes
•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 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; Patients treated with oral or nebulized bronchodilators in the 4 weeks prior to study start; Patients treated with nebulized corticosteroids in the 4 weeks prior to study start; Patients who have changed their dose or formulation of inhaled or nasal corticosteroids during the previous 4 weeks; Patients treated with fixed combination of inhaled corticosteroids and ß2\-agonists (e.g. Seretide®, Symbicort®) during the previous 4 weeks prior to study start; Patients undergoing immunotherapy; Patients treated with a xanthine derivative (e.g. theophylline) any formulation in the 4 weeks prior to study start; Patients treated with sodium cromoglycate or nedocromil sodium in the 4 weeks prior to study start; History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiac disease; Patients with a QTc interval (Bazett’s formula) in the ECG test \> 450 msec in males or \> 470 msec in females; Serum potassium \< 3\.5 mmol/L or \> 6\.0mmol/L; Clinically significant or unstable concurrent disease, e.g. uncontrolled diabetes mellitus; uncontrolled hyperthyroidism, significant hepatic impairment, significant pulmonary disease other than asthma (e.g. tuberculosis, lung cancer), gastrointestinal disease (e.g. active peptic ulcer), neurological or haematological autoimmune disorders; 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 (oral contraception, IUD, tubal ligature, double barrier method). A pregnancy test will be performed at screening in women of childbearing potential; History of alcohol or drug abuse; Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta\-blockers; Allergy, sensitivity or intolerance to beta2\-adrenergic 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.