PROSPECTIVE, RANDOMIZED, OPEN-LABEL, MULTICENTRE,ACTIVE DRUG CONTROLLED, PARALLEL GROUP DESIGN CLINICAL TRIAL OF THE EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE 400 MCG FORMOTEROL 24 MCG FOSTER PMDI VIA HFA-134A VS. FLUTICASONE PROPIONATE 500 MCG SALMETEROL XINAFOATE 100 MCG DPI SERETIDE DISKUS IN THE 6 MONTHS STEP DOWN TREATMENT OF ADULT PATIENTS WITH CONTROLLED ASTHMA - ND
- Conditions
- ASTHMAMedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2006-005349-13-IT
- Lead Sponsor
- CHIESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion into the 8-week run-in period consenting male and female adult age 18-65 years, limits included patients with moderate persistent asthma for more or equal to 6 months; FEV1 or PEFR more or equal to 80 of the predicted normal value; treated with stabilised fluticasone 1000 mcg salmeterol 100 mcg daily for more or equal to 4 weeks; patients with controlled asthma defined as no nocturnal symptoms or awakenings, no exacerbations, no limitations of activities, daytime symptoms and use of rescue medication less or equal to 2 days per week in the last 4 weeks. Cooperative attitude Inclusion into the treatment period 61472;asthma controlled in each of the last 4 weeks of run-in no nocturnal symptoms or awakenings; no exacerbations; no limitations of activities; daytime symptoms for less or equal to 2 days; use of rescue medication less or equal to 2 days; morning PEF more or equal to 80 of predicted every day .
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) no
F.1.3.1 Number of subjects for this age range
Exclusion from the 8-week run-in period 61472;inability to carry out pulmonary function tests; 61472;diagnosis of COPD; 61472;current smokers or recent less or equal to 1 year ex-smokers with a smoking history of more or equal to 10 packs/years; 61472;history of near-fatal asthma; 61472;evidence of symptomatic infection of the airways in the previous 8 weeks; 61472;more or equal to 3 courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months; 61472;treatment with anticholinergics and antihistamines during the previous 2 weeks, with topical or intranasal corticosteroids and leukotriene antagonists during the previous 4 weeks; 61472;his tory or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; 61472;diabetes mellitus; 61472;percutaneous transluminal coronary angioplasty PTCA or coronary artery by-pass graft CABG during the previous six months; 61472;abnormal QTc interval value more to 450 msec in males or more to 470 msec in females in the ECG test or other haemodynamically relevant rhythm disturbances including atrial flutter or atrial fibrillation with ventricular response, bradicardia equal to 55 bpm , evidence of atrial-ventricular AV block on ECG of more than 1st degree; 61472;clinically significant or unstable concurrent diseases uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary tuberculosis, active mycotic infection of the lung , gastrointestinal e.g. active peptic ulcer , neurological or haematological autoimmune diseases; 61472;cancer or any chronic diseases with prognosis less to 2 years; 61472;pregnant or lactating females or females of childbearing potential not demonstrating adequate contraception; 61472;history of alcohol or drug abuse; 61472;regular treatment with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers; 61472;allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients; 61472;Patients unlikely to comply with the protocol 61472; 61472;subjects treated with any investigational new drug within the last 12 weeks; 61472;subjects previously enrolled in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs and that Foster is equivalent to the reference medication in maintaining the control of asthma;Secondary Objective: N.A.;Primary end point(s): N.A.
- Secondary Outcome Measures
Name Time Method