DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Alvesco (Ciclesonide Inhalation) - Summary

 
 



ALVESCO SUMMARY

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

ALVESCO is indicated for the following:

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 >>

NEWS HIGHLIGHTS

Media Articles Related to Alvesco (Ciclesonide Inhalation)

VR475 shown significant benefit in a Phase IIb/III trial for severe asthma
Source: Respiratory / Asthma News From Medical News Today [2014.12.12]
Vectura Group plc has announced the publication in the European Respiratory Journal (ERJ) of a clinical study demonstrating positive results from its Phase IIb/III (Acti-AICS-001) clinical trial...

Asthma
Source: MedicineNet Allergy Specialty [2014.12.12]
Title: Asthma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/12/2014 12:00:00 AM

Bed-sharing toddlers 'more likely to develop asthma in later childhood'
Source: Respiratory / Asthma News From Medical News Today [2014.12.11]
Examining an association between toddlers who share the bed with their parents and risk of asthma later in childhood, researchers suggest that the link is multifactorial.

Raised Asthma Risk Seen for Toddlers Who Share Bed With Parents
Source: MedicineNet Sleep Specialty [2014.12.11]
Title: Raised Asthma Risk Seen for Toddlers Who Share Bed With Parents
Category: Health News
Created: 12/11/2014 12:00:00 AM
Last Editorial Review: 12/11/2014 12:00:00 AM

Asthma data shows no additional clinical efficacy benefits for ICS-treatments with a small particle size
Source: Respiratory / Asthma News From Medical News Today [2014.12.09]
GSK has presented data at the British Thoracic Society (BTS) meeting from a systematic analysis of 25 randomised control studies (RCTs), including a meta-analysis of three key efficacy outcomes...

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) [Recruiting]
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 .

Omnaris Versus Levocetirizine Phase 4 Study [Recruiting]

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR) [Recruiting]
This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR). [Recruiting]
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

Ciclesonide for the Treatment of Airway Hyperresponsiveness (BY9010/CH-101) [Recruiting]
The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.

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: 2014-12-12

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014