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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, randomised, double blind, double dummy, placebo-controlled, three-period crossover clinical study, comparing the efficacy, safety and tolerability of Formoterol-HFA pMDI 12 microgram per actuation administered by means of a "spacer" device (AeroChamber Plus) with that of Formoterol-HFA pMDI 12 microgram per actuation in 5- to 12-year-old children with persistent moderate to severe asthma
The objective of this study is to demonstrate that Formoterol-HFA pMDI 12 µg with spacer (AeroChamber Plus) is clinically equivalent in terms of efficacy to Formoterol-HFA pMDI following a single dose...
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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 study to evaluate the effects of two different doses given once of the combination of two components (beclomethasone plus formoterol) given in two different inhalation formulations to patients with chronic obstructive pulmonary disease
To compare the average heart rate over 4 hours after administration of BDP and Formoterol using CHF 1535 100/6 NEXThaler® DPI and CHF 1535 100/6 pMDI at two different dose levels
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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 PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS
To demonstrate the equivalence in terms of FEV1 between CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily) and an equipotent dose of Seretide® Diskus® (fluticasone plus salmeterol, ...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A study to evaluate whether a new inhaled medicine (combination of beclometasone plus formoterol plus glycopyrronium) works as well as a licensed medicine (combination of indacaterol and glycopyrronium) in patients with chronic obstructive pulmonary disease
To demonstrate the superiority of CHF 5993 pMDI over Ultibro® in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment.
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A RESEARCH STUDY TO EVALUATE THE EFFECT OF ONE ADMINISTRATION OF A PEDIATRIC INHALED COMBINED FORMULATION (BECLOMETASONE PLUS FORMOTEROL) IN CHILDREN WITH ASTHMA
-To evaluate, in children, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after inhalation of CHF 1535 35/4 NEXThaler® in comparison with a free combination of licensed BDP DPI a...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
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
To characterise the mean trough 23-24 hrs FEV1 following 4 weeks of treatment (Visit 6/Day 28) of CHF 4226 2µg given q.d. in the evening and to compare it with placebo.
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE BRONCHODILATOR EFFICACY AND SAFETY AFTER SINGLE AND REPEATED ADMINISTRATIONS OF DIFFERENT DOSES OF GLYCOPYRROLATE VIA PMDI IN MODERATE TO SEVERE COPD PATIENTS. (GLYCO 2)
PART I • To assess the safety and tolerability of single administration of Glyco pMDI at 5 dose levels in patients with moderate to severe COPD PART II • To assess the bronchodilator efficacy of Gly...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA
The primary objective of the study will be to demonstrate that Tobrineb/Actitob®/ Bramitob® is noninferior to TOBI® in primary efficacy variable forced expiratory volume in one second (FEV1) percent p...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A trial of the long-term safety of Lamazym aftercare treatment of subjects with alpha-Mannosidosis who previously participated in Lamazym-trials
The overall objective of the trial is to provide aftercare treatment with Lamazym and to evaluate the safety and efficacy of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis who pre...
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Femme et Homme Max 99 ans
Chiesi Farmaceutici S.p.A
MAJ Il y a 4 ans
A RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 3 WAY CROSS-OVER STUDY TO EVALUATE THE EFFECT ON TROUGH FEV1 AFTER 4 WEEKS TREATMENT WITH CHF 5188 pMDI QD (FIXED COMBINATION BUDESONIDE / CARMOTEROL) IN ADULT PATIENTS WITH MODERATE OR SEVERE PERSISTENT ASTHMA
To demonstrate superiority of CHF5188 pMDI 400/4µg administered once-a-day in the morning over budesonide extrafine pMDI on trough FEV1 after 4 weeks of treatment in persistent moderate or severe asth...
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