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This is an integrated Phase 1, single centre, multi-part, open-label study in both healthy subjects (Part 1), subjects with mild stable asthma (Part 2) and subjects with mild to moderate stable asthma (Part 3). In all parts of the study (i.e. Parts 1, 2 and 3) every effort will be made to include as close as possible an equal balance between male and female subjects; in Part 1 and Part 2 this will be in each of the individual cohorts.
Safety, tolerability and PK will be assessed following either single ascending (SAD) or multiple ascending (MAD) dosing of ZP-059; Part 1 and Part 2, respectively.
Allergic Bronchopulmonary Aspergillosis
Voriconazole inhaled (ZP-059), Cross-over with VFEND
Medicines Evaluation Unit Ltd. (MEU)
Not yet recruiting
Published on BioPortfolio: 2020-01-21T11:31:59-0500
To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patie...
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea...
This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency
A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic characteristics of voriconazole in CYP2C19 poor metabolizers
A pilot study was performed to evaluate the appropriateness of the voriconazole dosing regimen based on the population pharmacokinetic model and the influence of sex on the pharmacokinetic...
Allergic bronchopulmonary aspergillosis (ABPA) is an allergic pulmonary disease caused by a hypersensitivity reaction to Aspergillus colony in the airways. Due to the diversity of disease manifestatio...
Oral itraconazole has variable pharmacokinetics and risks of adverse events (AEs) associated with high plasma exposure. An inhalation formulation of itraconazole (PUR1900) is being developed to treat ...
Allergic bronchopulmonary aspergillosis (ABPA) complicated with pulmonary thromboembolism (PTE) is rare. This report describes a patient who was diagnosed with ABPA and soon developed PTE.
The clinical utility of IgE against recombinant Aspergillus fumigatus-specific (rAsp) antigens in allergic bronchopulmonary aspergillosis (ABPA) remains unclear.
Allergic bronchopulmonary aspergillosis (ABPA) may be a risk factor for poorly controlled asthma in children. The studies regarding prevalence and risk factors of ABPA in children with poorly controll...
Hypersensitivity reaction (ALLERGIC REACTION) to fungus ASPERGILLUS in an individual with long-standing BRONCHIAL ASTHMA. It is characterized by pulmonary infiltrates, EOSINOPHILIA, elevated serum IMMUNOGLOBULIN E, and skin reactivity to Aspergillus antigen.
Infections of the respiratory tract with fungi of the genus ASPERGILLUS. Infections may result in allergic reaction (ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS), colonization in pulmonary cavities as fungus balls (MYCETOMA), or lead to invasion of the lung parenchyma (INVASIVE PULMONARY ASPERGILLOSIS).
Allergic rhinitis that occurs at the same time every year. It is characterized by acute CONJUNCTIVITIS with lacrimation and ITCHING, and regarded as an allergic condition triggered by specific ALLERGENS.
Illicit use of chemicals and products whose vapors can be inhaled to produce a rapid mind-altering effect. Inhalants include aerosols, gases, and volatile solvents that are often inhaled repeatedly to achieve the short-lived intoxicating effect.
A triazole antifungal agent that specifically inhibits STEROL 14-ALPHA-DEMETHYLASE and CYTOCHROME P-450 CYP3A.
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...