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Kusajili – Centralise les essais cliniques mondiaux
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de votre recherche par promoteur : Chiesi Farmaceutici S.p.A
Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE 50 µg PLUS FORMOTEROL FUMARATE 6 µg ) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETASONE DPI AND FORMOTEROL DPI IN ASTHMATIC CHILDREN
Primary: - To evaluate, in children, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t , after inhalation of CHF 1535 NEXT DPI® in comparison with a free combination of licensed B...
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Essai clos aux inclusions
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A clinical study to look at the safety, effectiveness and how COPD patients tolerate a new compound CHF6001 which will be inhaled daily for 28 days compared with existing treatment and placebo
The primary objectives of the study are: - to evaluate the effect of CHF 6001 DPI on biological markers of inflammation in induced sputum and in the blood, and on pulmonary function. - to evaluate t...
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Essai clos aux inclusions
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A SINGLE-DOSE, OPEN-LABEL, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 HFA pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 50µg PLUS FORMOTEROL FUMARATE 6 µg ) USING THE AEROCHAMBER PLUS™ SPACER DEVICE VERSUS THE FREE COMBINATION OF BECLOMETHASONE HFA pMDI AND FORMOTEROL HFA pMDI AVAILABLE ON THE MARKET USING THE AEROCHAMBER PLUS™ SPACER DEVICE IN ASTHMATIC CHILDREN
Primary Objective(s). To evaluate, in children, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t , after inhalation of CHF 1535 pMDI 50/6 with spacer device in comparison with an ...
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Essai clos aux inclusions
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
Multinational Clinical Trial of 12 weeks of duration to test the efficacy and safety of a new drug called CHF 1535 200/6µg (fixed combination beclomethasone dipropionate / formoterol) versus beclomethasone dipropionate in adults asthmatic patients not adequately controlled on high doses of inhaled corticosteroids or on medium dose of inhaled corticosteroids plus long-acting β2 agonists
To show the superiority of CHF 1535 (BDP/FF) pMDI (800/24µg per day) over BDP HFA (Qvar®) pMDI (800µg per day) in terms of lung function considering change from baseline to the entire treatment period...
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unknown
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A PHASE II, MONOCENTRE, OPEN, RANDOMIZED, 6-WAY CROSS-OVER CLINICAL PHARMACOLOGY STUDY TO EVALUATE THE LUNG BIOAVAILABILITY OF BDP/B17MP AND FORMOTEROL AND THE TOTAL SYSTEMIC EXPOSURE ACROSS TWO DIFFERENT DOSE STRENGTHS OF CHF 1535 NEXThaler® DPI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE 100/6 µg and 200/6 µg) ADMINISTERED WITH AND WITHOUT ACTIVATED CHARCOAL IN ADULT ASTHMATIC PATIENTS
• To evaluate the lung bioavailability of B17MP (active metabolite of BDP) and formoterol as AUC0-t across two different dose strengths of CHF 1535 NEXThaler DPI (100/6 µg, 200/6 µg) with activated ch...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A 48-WEEK, DOUBLE BLIND, RANDOMIZED, MULTINATIONAL, MULTICENTRE, 2-ARM PARALLEL GROUP, REFERENCE TREATMENT CONTROLLED CLINICAL TRIAL OF “FIXED COMBINATION” BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA pMDI (CHF 1535 FOSTER®) VERSUS FORMOTEROL IN PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE
To demonstrate that CHF 1535 twice daily is superior to Formoterol twice daily in terms of COPD exacerbations rate after 48 weeks of treatment and in terms of pulmonary function (change in pre-dose mo...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
Multicentre, randomized research study to test the safety and efficacy of Foster® compared to Symbicort® on small airway function in patients with COPD (Chronic Obstructive Pulmonary Disease)
To demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction in patien...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
Korttidsvækst hos børn med astma og optagelse af beclometason og formoterol givet i én spray på spacer til børn
The primary objective of the study is to show that CHF 1535 50/6µg pMDI, 2 inhalations bid (total daily dose: BDP 200μg / FF 24μg) using AeroChamber Plus™ spacer device is non-inferior to a correspond...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
2 part study in spontaneously breathing preterm neonates with mild to moderate respiratory distress syndrome
Part I: Objective To assess the safety and tolerability of three single ascending doses of nebulized Curosurf®. Part II Objective To compare the efficacy of nebulized Curosurf®, administered at low...
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unknown
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A MULTICENTER, MULTINATIONAL, SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 2-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI IN ASTHMATIC ADOLESCENTS AND ADULTS PATIENTS
To evaluate the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after four single inhalations of fixed combination CHF1535 100/6 NEXT DPI® (total dose: BDP 400 μg / FF 24 μg) in compa...
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