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Study of the Effects of Ciclesonide on Hypothalamic-Pituitary-Adrenal (HPA) Axis

2014-08-27 03:17:12 | BioPortfolio

Summary

To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Perennial Allergic Rhinitis

Intervention

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

Location

Clinical Research Atlanta
Stockbridge
Georgia
United States
30281

Status

Completed

Source

Sepracor, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:12-0400

Clinical Trials [1403 Associated Clinical Trials listed on BioPortfolio]

Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)

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...

Dose-Ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)

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...

Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis

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.

A 6 Month Study of Once Daily Ciclesonide HFA Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

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 ...

Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

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.

PubMed Articles [855 Associated PubMed Articles listed on BioPortfolio]

Intranasal Filtration of Inhaled Aerosol in Human Subjects as a Function of Nasal Pressure Drop.

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...

Pediatric Nasal Traumas: Contribution of Epidemiological Features to Detect the Distinction Between Nasal Fractures and Nasal Soft Tissue Injuries.

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...

Pediatric Nasal Obstruction.

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...

Re: "Harmonizing the Nomenclature for Therapeutic Aerosol Particle Size: A Proposal" by Hillyer et al. (J Aerosol Med Pulm Drug Deliv. 2018 31(2):111-113; DOI: 10/1089/jamp.2017.1396).

Does using a nasal barrier dressing prevent nasal injury in premature infants receiving nasal continuous positive airway pressure?

Medical and Biotech [MESH] Definitions

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.

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