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To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety and efficacy study of the effects of ciclesonide HFA nasal aerosol and ciclesonide AQ nasal spray on the HPA axis, when administered once daily to male and female subjects 12 years or older diagnosed with Perennial Allergic Rhinitis (PAR).
The study consists of a screening period, a single blind run in period, a 6 week double blind treatment period including an active control segment, and a follow up period.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Perennial Allergic Rhinitis
Ciclesonide HFA Nasal Aerosol 320 mcg, Ciclesonide HFA Nasal Aerosol 160 mcg, HFA Nasal Aerosol placebo, Ciclesonide Aqueous Nasal Spray 200 mcg, AQ Nasal Spray Placebo, Dexamethasone, Placebo, Placebo
Clinical Research Atlanta
Published on BioPortfolio: 2014-08-27T03:17:12-0400
The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-me...
The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA, applied as a nasal aerosol once daily, in patients with SAR. The secondary objectives are to evaluate...
To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.
6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily ...
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.
Intersubject variability in nasal deposition of inhaled aerosol is significant because of the differences in nasal anatomy and breathing rate. The notable limitation of the majority of previously deve...
The biological impact of an aerosol of a potential modifiedrisk tobacco product, carbon heated tobacco product 1.2 (CHTP1.2), was comprehensively assessed for the first time in vitro using human small...
Nasal bone is prone to injury due of its prominent position on the face. Epidemiologic surveys are necessary to investigate nasal traumas. The aim of the present study is to examine the distribution o...
Nasal obstruction is one of the most common problems seen by pediatric otolaryngologists. Prompt treatment of nasal obstruction can be critical in newborns and infants because of their obligatory nasa...
Fluid obtained by irrigation or washout of the nasal cavity and NASAL MUCOSA. The resulting fluid is used in cytologic and immunologic assays of the nasal mucosa such as with the NASAL PROVOCATION TEST in the diagnosis of nasal hypersensitivity.
The proximal portion of the respiratory passages on either side of the NASAL SEPTUM. Nasal cavities, extending from the nares to the NASOPHARYNX, are lined with ciliated NASAL MUCOSA.
Application of allergens to the nasal mucosa. Interpretation includes observation of nasal symptoms, rhinoscopy, and rhinomanometry. Nasal provocation tests are used in the diagnosis of nasal hypersensitivity, including RHINITIS, ALLERGIC, SEASONAL.
Diagnostic measurement of the nose and its cavity through acoustic reflections. Used to measure nasal anatomical landmarks, nasal septal deviation, and nasal airway changes in response to allergen provocation tests (NASAL PROVOCATION TESTS).
The type species of the genus INFLUENZAVIRUS A that causes influenza and other diseases in humans and animals. Antigenic variation occurs frequently between strains, allowing classification into subtypes and variants. Transmission is usually by aerosol (human and most non-aquatic hosts) or waterborne (ducks). Infected birds shed the virus in their saliva, nasal secretions, and feces.
Diabetes Diabetes Endocrine Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several groups of h...
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...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...