Trova impiego nella profilassi e nel trattamento dell' asma bronchiale, delle riniti allergiche e della rettocolite e proctosigmoidite ulcerosa. In clinica viene spesso utilizzato sotto forma di profarmaco , il beclometasone dipropionato. Si preferisce l' esterificazione con l' acido propionico in quanto la molecola vede un incremento della propria lipofilia, che ne facilita l'assorbimento da parte della mucosa nasale e, in generale, delle membrane fosfolipidiche. La molecola esterificata viene successivamente biotrasformata nell'organismo nella sua forma attiva, appunto il beclometasone. Si presenta come una polvere bianca inodore, poco solubile in acqua ma facilmente solubile in etanolo e acetone.
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Review by the Competent Authority or Ethics Committee in the country concerned. As of 1. EU Clinical Trials Register. Search tools. Select Date Range: to. Select Rare Disease:. IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:.
Biosensors in the exhaled breath analysis: comparison between healthy and asthmatic adults and effect of montelukast and fluticasone on frequency pattern detected by biosensors in adults with asthma. Analisi del respiro mediante biosensori nell asma.
The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy. Male or females adults, aged 15 to 70 years, have atopic mild persistent asthma at step 2 of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institute of Health as defined by a history of symptoms more than twice a week but less than daily step 2.
Positive skin prick testing. Patient fulfills all the following signs and symptoms of asthma by visit 2: a History of symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production for at least 12 months.
This must be demonstrated twice at visits 1 and 2. Patient is able to chew a tablet and inhale drug from a dry powder inhaler. Ability to perform reproducible spirometry. Nonsmoker including no use of smokeless tobacco products in the past year.
Ability of parent to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject s respective study institution, with assent from the child. Women give up pregnancy throughout the study duration 5 weeks.
Presenza dei seguenti segni e sintomi di asma precedentemente alla visita 2: a. Questo deve essere dimostrato due volte alla visita 1 e 2. Assenza di storia di fumo compresi prodotti del tabacco non da fumo nell ultimo anno. Patient is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material. Patient is hospitalized. Patient has undergone any major surgical procedure within four weeks of visit 1.
Patient has, in addition to asthma, any active, acute or chronic pulmonary disorder documented by history or physical examination. Patient received 4 or more oral corticosteroid bursts for asthma exacerbations in the past year. Patient has unresolved symptoms and signs of an upper respiratory tract infection URI within three weeks of visit 1 or during the run-in period.
Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems, or an immunodeficiency, or an autoimmune disorder. Patient has a history of any illness that would require treatment with an excluded medication, could be immediately life threatening, would pose restriction on participation or successful completion of the study, or would pose an additional risk to the patient by administering the study drugs.
Patient has taken the following medications: a Oral, intravenous, intramuscular, intra-articular or inhaled corticosteroids within 4 weeks of visit 1 with the exception of nasal corticosteroids administered on a continuous basis. Patient has started immunotherapy within six months of visit 1. Patient is unable or unwilling to comply with the study procedures as determined during the run-in period, including compliance with study medication.
Persone che non sono in grado di fornire il consenso informato. Pazienti ricoverati in ospedale. Pazienti che abbiano subito un intervento chirurgico nelle 4 settimane precedenti la visita 1. Presenza di patologie polmonari acute o croniche, oltre ad asma, evidenziate dall anamnesi o esame obiettivo. Infezioni delle vie respiratorie superiori nelle tre settimane precedenti la visita 1.
Patologie gastrointestinali, cardiovascolari, epatiche, neurologiche, renali, genitourinarie, ematologiche, endocrine, oftalmiche, articolari, sindromi da immunodeficienza o malattie autoimmunitarie, malattie dell apparato locomotore. Pazienti che abbiano preso i seguenti farmaci: a glucocorticoidi per os, endovena, intramuscolo, intra-articolari o inalatori nelle 4 settimane precedenti la visita 1 con l eccezione degli steroidi intranasali somministrati cronicamente.
Pazienti che hanno iniziato la immunoterapia nei 6 mesi precedenti la visita 1. I pazienti non sono in grado o non vogliono seguire le procedure dello studio compresa la compliance con la terapia con montelukast o fluticasone. Concentrations of exhaled nitric oxide. The trial involves single site in the Member State concerned.
Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial.