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Alvesco (Ciclesonide Inhalation) - Summary



The active component of ALVESCO 80 mcg Inhalation Aerosol, and ALVESCO 160 mcg Inhalation Aerosol is ciclesonide, a non-halogenated glucocorticoid.

Treatment of Asthma

ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

  •   Important Limitations of Use:
  •   ALVESCO is NOT indicated for the relief of acute bronchospasm.
  •   ALVESCO is NOT indicated for children under 12 years of age.

See all Alvesco indications & dosage >>


Media Articles Related to Alvesco (Ciclesonide Inhalation)

Childhood asthma: Looking on the brighter side
Source: Respiratory / Asthma News From Medical News Today [2015.11.27]
The effect of a widespread genetic variant that increases the risk for childhood asthma can be neutralized.

Early childhood bronchiolitis increases asthma risk in adulthood
Source: Respiratory / Asthma News From Medical News Today [2015.11.24]
Persons who have had bronchiolitis in early childhood have an increased risk of asthma at the age of 28-31 and a weaker health-related quality of life than their peers.

Asthma Treatment Before School Cuts Exacerbations
Source: MedPage Today Allergy & Immunology [2015.11.24]
(MedPage Today) -- In this MedPage Today video report, David Lang, MD, explains the value of pretreatment

Allergy and Asthma Sufferers Beware as Holiday Season Kicks In
Source: MedicineNet Allergy Specialty [2015.11.23]
Title: Allergy and Asthma Sufferers Beware as Holiday Season Kicks In
Category: Health News
Created: 11/21/2015 12:00:00 AM
Last Editorial Review: 11/23/2015 12:00:00 AM

High levels of physical activity may worsen asthma control in young females
Source: Respiratory / Asthma News From Medical News Today [2015.11.19]
Among 526 adolescents and young adults who were asked about their exercise habits, those with asthma tended to report more physical activity than those without asthma.

more news >>

Published Studies Related to Alvesco (Ciclesonide Inhalation)

An investigation of the pharmacokinetics, pharmacodynamics, safety, and tolerability of ciclesonide hydrofluoroalkane nasal aerosol in healthy subjects and subjects with perennial allergic rhinitis. [2011.08]
Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development for treatment of allergic rhinitis. This Phase I study evaluated the pharmacokinetics, pharmacodynamics, safety, and tolerability of CIC-HFA in healthy subjects (N = 18) and subjects with perennial allergic rhinitis (PAR, N = 18) in a double-blind, placebo-controlled, 3-period crossover design following treatment with 282 mug or 148 mug CIC-HFA or placebo once-daily for 14 days...

Simultaneous determination of ciclesonide and its active metabolite desisobutyryl-ciclesonide in human plasma by LC-APCI-MS/MS: application to pharmacokinetic study in healthy Chinese volunteers. [2011.04.28]
A sensitive and highly selective liquid chromatography tandem mass spectrometric (LC/MS/MS) method was developed and validated for the determination of ciclesonide (CIC) and its active metabolite, desisobutyryl-ciclesonide (des-CIC), in human plasma... The method was fully validated and successfully applied to determine CIC and des-CIC simultaneously in human plasma and proved to be suitable for phase I clinical pharmacokinetic study of inhaled ciclesonide in healthy Chinese volunteers.

Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control. [2011.02]
BACKGROUND: Patients with mild persistent asthma constitute about 70% of the asthma population; thus, it is important to know which first-line treatment is best for the management of mild asthma. We compared benefits of first-line treatment with ciclesonide and a combination of fluticasone and salmeterol in patients with mild asthma... CONCLUSIONS: In mild asthma, FP200/S100 prolonged time to first severe asthma exacerbation, and CIC160 and FP200/S100 were clinically equieffective for most measures of asthma control. Trial registry: ClinicalTrials.gov; No.: NCT00163358; URL: www.clinicaltrials.gov.

Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 mug once daily, for the treatment of seasonal allergic rhinitis. [2010.12]
BACKGROUND: A hypotonic aqueous nasal spray of ciclesonide is indicated for the treatment of allergic rhinitis (AR). A new nasal aerosol formulation of ciclesonide containing a hydrofluoroalkane propellant delivered via a metered-dose inhaler (CIC-HFA) is currently in clinical development as a potential treatment for AR. OBJECTIVES: To study the efficacy and safety of once-daily administration of CIC-HFA 80 or 160 mug compared with placebo in subjects 12 years and older with seasonal AR (SAR)... CONCLUSIONS: In this study, once-daily treatment with CIC-HFA 80 or 160 mug demonstrated statistically significant improvements in nasal and ocular symptoms of SAR. Both doses of active treatment were well tolerated. Copyright (c) 2010 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of ciclesonide in patients with severe asthma: a 12-week, double-blind, randomized, parallel-group study with long-term (1-year) follow-up. [2010.12]
CONCLUSIONS: Ciclesonide 320 mug b.i.d. sustained lung function and asthma symptoms in patients with severe asthma over 12 weeks' treatment, and maintained lung function during a 40-week EP; ciclesonide 640 mug b.i.d. did not provide additional benefits. Long-term use of ciclesonide was not associated with increased local AEs or negative effects on cortisol levels.

more studies >>

Clinical Trials Related to Alvesco (Ciclesonide Inhalation)

ATEM (Alvesco Non-interventional Study) [Completed]
The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco .

Asthma Care With Alvesco (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102) [Completed]
The purpose of this study is to investigate the effectiveness of Alvesco (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco or usual care.

Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis [Recruiting]
This study will provide the clinicians guidance on the safest combination of inhaled and nasal corticosteroids for children with mild asthma and allergic rhinitis respectively; however, one safety concern is that these products are independently known to have dose-related effects on short term and intermediate term growth. Knemometry is a non invasive technique for measuring short-term lower leg growth in children and is currently the method of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.

Omnaris Versus Levocetirizine Phase 4 Study [Completed]

Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis [Completed]

more trials >>

Reports of Suspected Alvesco (Ciclesonide Inhalation) Side Effects

Dermatitis Allergic (4)Asthma (3)Dyspnoea (3)Bronchitis Bacterial (3)Agitation (2)Hallucination, Auditory (2)Cerebrovascular Disorder (2)Headache (2)Palpitations (2)Bronchospasm (2)more >>

Page last updated: 2015-11-27

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