Mild to moderate adult persistent asthmatic patients MedDRA version: 7.0 Level: low Classification code 10003553
Conditions
Interventions
Product Name: BDP+Formoterol
Product Code: CHF 1535
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Beclomethasone Dipropionate
Concentration unit: µg microgram(s)
Concentra
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged > 18 60% and 12% of thei baseline FEV1 and > 200ml, 15 minutes after 2 puffs (2' 100mcg) of inhaled salbutamol (pMDI) performed within last two years. The condition causing the airflow obstruction should have been stable on the same regular treatment for at least 4 weeks. A cooperative attitude and ability to be trained in the proper use of a pMDI. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or lactating females or women of childbearing potential without any efficient contraception (oestro-progestatives, condoms and/or intra-uterine devices). Heavy smokers defined as smoking for > 10 pack year. Having received an investigational drug within 30 days before the current study. Inability to perform outcome measurements optimally and to complete diary cards. Patients with lack of personal freedom decreed by a judicial or administrative authority. Patients not having signed their informed consent form. Evidence of asthma exacerbation having caused a hospitalization (even for a short period) or induced oral or parenteral corticosteroides treatment or evidence of symptomatic infection of the airways in the previous 4 weeks (3 months for slow-release corticosteroids) Seasonal asthma or asthma occuring only during episodic exposure to an allergen or an occupational chemical sensitizer. History of cystic fibrosis or bronchiectasis. History of clinically significant cardiac, renal, neurological, hepatic or endocrine diseases whose sequelae and/or treatments can interfere with the results of the present study. A particular oversight has to be kept towards patients with coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias, heart failure or diabetes mellitus. Any concomitant disease, which could interfere with the protocol according to investigator's opinion. Intolerance or contra-indication to treatment with b2-agonists and/or inhaled corticosteroids. Allergy to one component of medications used (beclomethasone dipropionate, formoterol fumarate dihydrate, tetrafluoroethane-134a, anhydrous alcohol, norflurane, CFC-11,12, lactose). Patiens already chronically treated or treated within the previous month with inhaled LABAs. Patients already receiving inhaled (including nasal) corticosteroids at a daily dose strictly greater than: 400mcg of Budesonide 200mcg Mometasone furoate 500mcg beclomethasone dipropionate or flunisolide 200mcg fluticasone propionate 200mcg BDP extra fine Anti-asthmatic treatment modification within the month preceding inclusion. Patients already receiving sodium cromoglycate, nedocromil sodium, theophylline or leukotriene antagonists for whom the dose is likely to change during the 14-week study period. Patients treated with oral or parenteral corticosteroids in the previous month (3 months for slow release corticosteroids). Patients treated with monoamine oxidase inhibitors, anticholinergics, tricyclic antidepressants or beta blockers as regulary use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the clinical superiority in terms of pulmonary function of CHF 1535 (formoterol and beclomethasone fixed combination) vs. double dose of beclomethasone alone in the 12- week treatment period of mild to moderate persistent asthma in adult patients;Secondary Objective: the evening PEF, the daily PEF variability (as reflect of bronchial hyper reactivity), morning and evening FEV1, FVC, FEV1/FVC, FEF25%, FEF75%, FEF25-75% calculated as the mean of the last 7 values obtained during the two last weeks of the treatment period, Pulmonary Function Test performed at each visit. morning and evening asthma clinical symptoms scores, percentage of nights and/or days free of clinical symptoms. Asthma control defined as no or minimal clinical symptoms, no emergency visits, minimal need for SABAs, no limitation on activities, PEF diurnal variability < 20% and no adverse effects from drugs SABA consumption. Adverse events and adverse drug reactions recording (described in chapter 9). Biological tests: Standard haematology and biochemistry. Morning serum cortisol. 12hr overnight urine cortisol/creatinine ratio;Primary end point(s): the morning Peak Expiratory Flow at the end of the treatment period and it will be calculated as the mean of the last seven values obtained during the two last weeks of the treatment period. | — |
Countries
Czech Republic, Slovakia
Outcome results
None listed