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Diana Brixner, Eli O Meltzer, Kellie Morland, Cathryn A Carroll, Ullrich Munzel, Brian J Lipworth
OBJECTIVES: Various minimal clinically important difference (MCID) threshold estimation techniques have been applied to seasonal allergic rhinitis (SAR). The objectives of this study are to (i) assess the difference in magnitude of alternative SAR MCID threshold estimates and (ii) evaluate the impact of alternative MCID estimates on health technology assessment (HTA). METHODS: Data describing change from baseline of the reflective Total Nasal Symptom Score (rTNSS) for four intranasal SAR treatments were obtained from United States Food and Drug Administration-approved prescribing information...
December 6, 2016: International Journal of Technology Assessment in Health Care
Nikolaos Spantideas, Eirini Drosou, Anastasia Bougea, Dimitrios Assimakopoulos
BACKGROUND: Voice problems are the most common and most annoying local side effect of inhaled corticosteroids (ICS), affecting not only patients' treatment compliance but also their quality of life. The literature is very poor regarding prevalence, mechanism, prevention, and management of voice problems attributed to ICS use and especially for the new ICS, ciclesonide. Prevalence of dysphonia seems to be less common with the use of ciclesonide and beclomethasone dipropionate. METHOD: We conducted a bibliography review based on recently published data, including data from the recently introduced ICS, ciclesonide, which are lacking in previous reviews...
October 11, 2016: Journal of Voice: Official Journal of the Voice Foundation
Kerry Dwan, Stephen J Milan, Lynne Bax, Nicola Walters, Colin Powell
BACKGROUND: Vilanterol (VI) is a long-acting beta2-agonist (LABA) that binds to the beta2-adrenoceptor on the airway smooth muscle, producing bronchodilation. LABA therapy, which is well established in adults as part of the British Thoracic Society (BTS) Guidelines for the Management of Asthma, leads to improvement in symptoms and lung function and reduction in exacerbations. At present, the commonly used LABAs licensed for use in asthma management (formoterol and salmeterol) require twice-daily administration, whereas VI is a once-daily therapy...
September 1, 2016: Cochrane Database of Systematic Reviews
Jatinder Kaur Mukker, Ravi Shankar Prasad Singh, Hartmut Derendorf
Inhaled corticosteroids are used as one of the first-line drug therapy in patients with asthma. However, their long-term use is associated with various oropharyngeal and systemic side and adverse effects. Design of pro-soft drug is one of the strategies, which was adopted in the design of ciclesonide for mitigation of side effects usually observed with the use of inhaled corticosteroids. Ciclesonide, a pro-soft drug, is converted to an active metabolite desisobutyryl-ciclesonide in the lungs. The anti-inflammatory effect of desisobutyryl-ciclesonide is much higher than ciclesonide, and therefore, the local effect of the metabolite is higher with lower systemic side effects...
September 2016: Journal of Pharmaceutical Sciences
Brian S Liddell, John M Oberlin, Daniel P Hsu
INTRODUCTION: This case series intends to highlight the association between decreased linear growth velocity and adrenal suppression in patients receiving inhaled corticosteroids for asthma. A potential treatment option is also discussed. Adrenal suppression secondary to inhaled corticosteroids has previously been reported and is often under recognized. A decrease in linear height velocity has also been associated with inhaled corticosteroids. However a decrease in height velocity has not been shown to predict adrenal suppression...
June 10, 2016: Journal of Asthma: Official Journal of the Association for the Care of Asthma
Sundeep S Salvi, Abhijit J Vaidya, Rahul R Kodgule, Jaideep A Gogtay
CONTEXT: The combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) is widely used in the treatment of moderate-to-severe asthma uncontrolled by ICS alone. AIMS: To evaluate the efficacy and safety of a new ICS-LABA combination inhaler containing Formoterol (F) and Ciclesonide (C). SETTINGS AND DESIGN: A double-blind, double-dummy, parallel group fashion, multi-centric study. SUBJECTS AND METHODS: A total of 169 asthma patients received Ciclesonide 80 μg once daily during a 4-week run-in period, after which, they were randomized to receive either C (80 μg) or a combination of F (4...
May 2016: Lung India: Official Organ of Indian Chest Society
Thys van der Molen, Dirkje S Postma, Richard J Martin, Ron M C Herings, Jetty A Overbeek, Victoria Thomas, Cristiana Miglio, Richard Dekhuijzen, Nicolas Roche, Theresa Guilbert, Elliot Israel, Wim van Aalderen, Elizabeth V Hillyer, Simon van Rysewyk, David B Price
BACKGROUND: Most randomised clinical trials typically exclude a significant proportion of asthma patients, including those at higher risk of adverse events, with comorbidities, obesity, poor inhaler technique and adherence, or smokers. However, these patients might differentially benefit from extrafine-particle inhaled corticosteroids (ICS). This matched cohort, database study, compared the effectiveness of extrafine-particle with fine-particle ICS in a real-life population initiating ICS therapy in the Netherlands...
2016: BMC Pulmonary Medicine
Geun-Mi Park, Hye Won Han, Jae Youn Kim, Eun Lee, Hyun-Ju Cho, Jisun Yoon, Soo-Jong Hong, Song-I Yang, Hyeon-Jong Yang, Jinho Yu
BACKGROUND: A key therapeutic approach to asthma, which is characterized by chronic airway inflammation, is inhaled corticosteroid (ICS). This study evaluated the association of symptom control with changes in lung function, bronchial hyperresponsiveness (BHR), and exhaled nitric oxide (eNO) after ICS treatment in asthmatic children. METHODS: A total of 33 children aged between 5 and 12 years with mild to moderate persistent asthma were treated with 160 μg ciclesonide per day for 3 months...
May 5, 2016: Allergology International: Official Journal of the Japanese Society of Allergology
Lee Yee Chong, Karen Head, Claire Hopkins, Carl Philpott, Martin J Burton, Anne G M Schilder
BACKGROUND: This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Topical (intranasal) corticosteroids are used with the aim of reducing inflammation in the sinonasal mucosa in order to improve patient symptoms...
April 26, 2016: Cochrane Database of Systematic Reviews
Payal H Mandaliya, Brendan Kennedy, Peter van Asperen, Paul D Robinson
No abstract text is available yet for this article.
September 7, 2015: Medical Journal of Australia
Loes E M Kistemaker, I Sophie T Bos, Mark H Menzen, Harm Maarsingh, Herman Meurs, Reinoud Gosens
BACKGROUND: The long-acting anticholinergic tiotropium has recently been registered for the treatment of asthma, and its use is associated with a reduction in exacerbation frequency. Anti-inflammatory and anti-remodeling effects of tiotropium have been demonstrated in in vitro and in vivo models. Because tiotropium treatment is used in combination with inhaled corticosteroids, potential additive effects between the two would be clinically relevant. Therefore, the aim of this study was to investigate additive effects between tiotropium and ciclesonide on airway inflammation and remodeling in guinea pig models of asthma...
2016: Respiratory Research
Marek L Kowalski, Piotr Wojciechowski, Marta Dziewonska, Przemyslaw Rys
BACKGROUND: Inhaled corticosteroids used for treating persistent asthma can suppress adrenal cortisol secretion. This inhibition of endogenous cortisol secretion is an important marker of systemic steroid activity. Although meta-analyses have demonstrated a dose-dependent suppression of cortisol by inhaled corticosteroids, regardless of inhaler type, the impact of novel freon-free inhaled corticosteroid preparations has not been reviewed. OBJECTIVE: The aim of this study was to synthesize all currently available studies on novel inhaled corticosteroid preparations, including ciclesonide, beclomethasone dipropionate, budesonide, and fluticasone propionate...
January 2016: Allergy and Asthma Proceedings:
R K Sen, S Prakash, S K Tripathy, A Agarwal, I M Sen
BACKGROUND: Many studies have established intravenous corticosteroid as an effective prophylactic therapy in fat embolism syndrome (FES). However, its use is limited among surgeons because of systemic side effects. Inhalational steroids have least systemic effects and are widely used for several chest conditions (i.e., asthma), but their effectiveness in FES has not been established. QUESTION/PURPOSE: This study was sought to evaluate the (1) efficacy and (2) safety of inhalational Ciclesonide (CIC) in prevention of FES and treatment of hypoxemia in isolated skeletal trauma victims...
January 18, 2016: European Journal of Trauma and Emergency Surgery: Official Publication of the European Trauma Society
Seyed MohammadReza Hashemian, Hamidreza Jamaati, Majid Malekmohammad
No abstract text is available yet for this article.
December 2015: Critical Care Medicine
Amit Kumar Agarwal, Ramesh Sen, Sujit K Tripathy, Sameer Aggarwal, Nirmalraj G, Dheeraj Gupta
Fat embolism syndrome (FES) is primarily a lung parenchymal disorder resulting from interstitial and alveolar inflammation triggered by the lipid metabolites in blood circulation. The 'low-dose' corticosteroid is supposed to have a prophylactic effect on the incidence of the FES and arterial hypoxemia by reducing this inflammatory response. It is expected that inhaled corticosteroids (ciclesonide aerosol) may prevent the development of hypoxemia or fat embolism syndrome in high-risk patients by reducing this inflammatory response...
September 25, 2015: Curēus
Ole D Wolthers
During recent years, extra-fine particle inhaled corticosteroids with a median aerodynamic diameter ≤2 μm have been introduced in the treatment of asthma. The aim of this paper was to review pharmacokinetics and systemic activity of extra-fine particle hydroalkane pressurized metered dose inhaled (pMDI) ciclesonide and beclomethasone dipropionate in children. A literature review was performed. Systemic bioavailability of oral and pulmonary deposition of extra-fine ciclesonide and beclomethasone dipropionate was 52% and 82%, the half-life in serum 3...
February 2016: Pediatric Allergy and Immunology
Ozlem Cavkaytar, Dogus Vuralli, Ebru Arik Yilmaz, Betul Buyuktiryaki, Ozge Soyer, Umit M Sahiner, Nurgun Kandemir, Bulent E Sekerel
The possible risk of adverse effects due to regular use of inhaled corticosteroids (ICS) is a real concern. Our aim was to describe the factors that have an impact on hypothalamic-pituitary-adrenal axis suppression (HPA-AS) in children and adolescents taking ICS regularly. The HPA axis status of patients who were on moderate-to-high-dose ICS [>176 and >264 μg/day fluticasone propionate-hydrofluoroalkane (FP-HFA) for patients 0-11 and ≥12 years, respectively] was investigated. Various types of ICS were converted to FP-HFA equivalent according to National Asthma Education and Prevention Program (NAEPP) guidelines...
November 2015: European Journal of Pediatrics
Hamidreza Jamaati, Majid Malekmohammad, Fanak Fahimi, Arvin Najafi, Seyed Mohammadreza Hashemian
BACKGROUND: The aim of this study was to compare the efficacy of ciclesonide (80 mg/day) and fluticasone propionate (200 mg/day) for mild to moderate persistent asthma. MATERIALS AND METHODS: Female and male patients older than 12 years with a history of persistent bronchial asthma for at least 6 months were enrolled. Patients were eligible to enter into a 2-week run-in period before randomization (baseline) if they had received inhaled corticosteroids (fluticasone propionate 250 μg/day or equivalent) at a constant dose during the last 4 weeks before the run-in period...
2015: Tanaffos
Marc Rohrschneider, Sharvari Bhagwat, Raphael Krampe, Victoria Michler, Jörg Breitkreutz, Günther Hochhaus
Assessing the dissolution behavior of orally inhaled drug products (OIDs) has been proposed as an additional in vitro test for the characterization of innovator and generic drug development. A number of suggested dissolution methods (e.g., commercially available Transwell or Franz cell systems) have in common a membrane which provides the separation between the donor compartment, containing nondissolved drug particles, and an acceptor (sampling) compartment into which dissolved drug will diffuse. The goal of this study was to identify and overcome potential pitfalls associated with such dissolution systems using the inhaled corticosteroids (ICS), viz...
August 3, 2015: Molecular Pharmaceutics
Thorsten Müller, Regina Scherließ, Jörg Schiewe, Rüdiger Smal, Claudius Weiler, Hartwig Steckel
In a former publication the authors showed that low amounts of amorphous content (LOQ of 0.5%) in a hydrophobic model API (Ciclesonide) can be measured with an individually adjusted one-step dynamic organic vapor sorption (DVS). In this investigation the applicability is tested on various APIs which differ in lipophilicity (poor water solubility) and hygroscopicity (absorption of water). The vapor sorption method proved to be applicable in almost all cases. Moisture sorption isotherms were determined for all five investigated crystalline and amorphous APIs...
August 2015: European Journal of Pharmaceutics and Biopharmaceutics
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