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Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study.

UNLABELLED: The fixed-dose combination of beclometasone dipropionate/formoterol fumarate (BDP/FF) delivered via pressurised metered-dose inhaler (pMDI) has demonstrated efficacy in chronic obstructive pulmonary disease (COPD), in studies predominantly conducted in Caucasian adults. The current study evaluated the efficacy and safety of BDP/FF pMDI in Chinese patients with COPD, as part of registration for COPD in China. This double-blind, double-dummy, randomised, parallel-group study was conducted in patients with COPD of Chinese ethnicity aged ≥40 years. After a 4-week open-label budesonide/

Endoscopic findings of immune checkpoint inhibitor-related gastrointestinal adverse events.

The use of immune checkpoint inhibitors (ICIs) for the treatment of various malignancies is increasing. Immune-related adverse events can occur after ICI administration, with gastrointestinal adverse events constituting a significant proportion of these events. When ICI-related diarrhea/colitis is suspected, endoscopic evaluation is recommended to differentiate it from other etiologies and assess the severity of colitis. The distribution of intestinal inflammation in ICI-related colitis demonstrates a high frequency of extensive colitis (23-86%). However, isolated right-sided colitis (3-8%) an

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… In a recent case report, oral beclomethasone was reported to induce clinical and histologic remission in two patients with ICI-related microscopic colitis. 36 Furthermore, Alexander et al. 37 reported that oral beclomethasone administration led to a clinical response in all 22 patients diagnosed with … Corticosteroids are recommended as first-line treatment for ICI-related diarrhea/colitis, whereas budesonide and oral beclomethasone are suitable for microscopic colitis. …

Evaluation of the combined medical and surgical treatment in nasal polyposis. I: functional results.

CONCLUSION: This prospective study is the first in the literature to present long-term results of a combined medical and surgical treatment in patients with nasal polyposis (NP) including strict inclusion criteria, analysis of the results in terms of clinical amelioration, polyp size reduction, and steroid consumption. The results of the present study show that combined surgery and corticosteroid therapy is effective in the treatment of NP. OBJECTIVE: Most publications on outcome after functional endoscopic sinus surgery (FESS) include patients with various pathologies. The aim of this study

Intranasal steroids and septum perforation--an overlooked complication? A description of the course of events and a discussion of the causes.

The use of intranasal steroids for the treatment of allergic and vasomotor rhinitis has doubled during the past 5 years. The number of reported cases of nasal septum perforation has increased correspondingly. The mechanism behind this is unknown, and steroid-induced septum perforation is rarely described in the literature. In order to describe the course of events and to form an idea of the extent of the problem, we have reviewed the cases reported at our clinic and compiled reports on side-effects from the Swedish Medical Products Agency. In our department we found 32 patients with septum per

Tolerability of Bisoprolol on Domiciliary Spirometry in COPD.

We investigated if serial domiciliary measures of spirometry were sensitive at detecting subtle effects of beta-2 blockade associated with bisoprolol in (n = 17) patients with COPD. After a two-week run in on inhaled corticosteroid (ICS) and long acting beta-2 agonist (LABA): beclometasone/formoterol 100/6 µg, patients' started additional a long acting muscarinic receptor antagonist: (LAMA) Tiotropium 18 µg, with concomitant weekly dose titration of bisoprolol: 1.25-2.5-5 mg. After a further week of bisoprolol 5 mg, they were stepped back down to (ICS/LABA) for one week. Mean age was 64 years,

Clinical studies in asthmatics with a new non-extra fine HFA formulation of beclometasone dipropionate (BDP Modulite).

The main objective of the clinical development programme for BDP Modulite, a new non-extra fine formulation of beclometasone dipropionate (BDP) in hydrofluoroalkane (HFA), has been to demonstrate therapeutic equivalence compared with standard BDP chlorofluorocarbon (CFC) products at the recommended posology (delivered dose and patient population). A total of 1158 asthmatic patients were included in five clinical studies and 658 patients were treated with BDP Modulite. Four studies were undertaken in mild or moderate-to-severe asthmatic adults, while one study was carried out in children. The d

Inhaled corticosteroids do not prevent the development of tolerance to the bronchoprotective effect of salmeterol.

INTRODUCTION: Twice-daily inhaled salmeterol produces rapid reduction in its acute bronchoprotective effect against methacholine in patients with mild asthma. This investigation examined this effect in patients with moderate asthma who were using inhaled corticosteroids. SUBJECTS AND METHODS: Eight asthmatic volunteers who required inhaled corticosteroids for control of their symptoms and who were able to withhold treatment with beta 2-agonists for 4 weeks before and during the study participated in a double-blind, crossover, placebo-controlled study with two random-order treatment periods: i

Clinical outcomes and adverse effect monitoring in allergic rhinitis.

The subjective recording in diary cards of symptoms of itch, sneeze, nose running, and blockage, with the use of a rating scale to indicate … y significant effect on growth in children has been identified with the long-term use of intranasal beclomethasone when administered twice daily for 1 year, this is not evident with all intranasal steroids. In addition, twice-daily intranasal steroid administration may have more effect--from the endocrinologic perspective--than once-daily administration in the m …

Association between corticosteroid use and vertebral fractures in older men with chronic obstructive pulmonary disease.

Osteoporosis is a major complication of long-term corticosteroid administration, but the magnitude of the effect in patients with chronic obstructive pulmonary disease (COPD) is not well defined. In a cross-sectional study, we evaluated the association between steroid use and vertebral fractures in 312 men, 50 yr of age or older, with COPD. Subjects were evaluated according to their corticosteroid use: Never Steroid Users (NSU) (n = 117), Inhaled Steroid Users (ISU) (n = 70), and Systemic Steroid Users (SSU) (n = 125). The prevalence of one or more vertebral fractures was 48.7% in the NSU grou

Stopping long-acting beta2-agonists (LABA) for children with asthma well controlled on LABA and inhaled corticosteroids.

BACKGROUND: Asthma is the most common chronic medical condition among children and is one of the most common causes of hospitalisation and m … ICS and LABA.We included any dose of LABA (formoterol, salmeterol, vilanterol) and any dose of ICS (beclomethasone, budesonide, ciclesonide, mometasone, flunisolide, fluticasone propionate, fluticasone furoate, triamcinolone) delivered in a combination inhaler or in separate inhalers. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all r …

The Real-World Efficacy of Fixed Triple Inhalation Therapy in the Treatment of Moderate COPD Patients (RATIONALE Study).

PURPOSE: COPD affects more than 300 million people worldwide, requiring inhalation treatment. Novel triple formulations of ICS, LABAs and LAMAs are becoming the mainstay of treatment, however there is still a lack of clinical evidence for personalized therapy. PATIENTS AND METHODS: RATIONALE was a non-interventional, prospective, 52 week study, assessing the effectiveness of beclometasone/formoterol/glycopyrronium-bromide (BDP/FF/G), in symptomatic COPD patients, with moderate airflow obstruction. The study included 4 visits, where data on demographic parameters, exacerbations, symptoms, qual

Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA.

BACKGROUND: Current pharmacological therapies for COPD improve quality of life and symptoms and reduce exacerbations. Given the progressive nature of COPD, it is arguably more important to understand whether the available therapies are able to delay clinical deterioration; the concept of "clinically important deterioration" (CID) has therefore been developed. We evaluated the efficacy of the single-inhaler triple combination beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G), using data from three large 1-year studies. METHODS: The studies compared BDP/FF/G to BDP/

Equivalent efficacy and safety of a new HFA-134a formulation of BDP compared with the conventional CFC in adult asthmatics.

The present study demonstrates the equivalent efficacy for BDP 500 microg bid given via MDI with the new HFA-134a propellant (Chiesi Farmaceutici S.p.A., Parma) compared to a conventional CFC propellant (Becotide, Allen & Hanburys, UK). One hundred and sixteen adult patients with stable mild to moderate asthma (FEV1 > or = 60% of predicted normal) entered a 2-week run-in period where they maintained their own inhaled corticosteroids and were then assigned to a 12-week treatment with the test drug in a randomized, multicentre, double-blind, double-dummy, parallel-group design. Ninety-one patien

Prognostic factors and outcomes of severe gastrointestinal GVHD after allogeneic hematopoietic cell transplantation.

We hypothesized that clinical risk factors could be identified within 2 weeks of onset of severe (stage 3 or 4) acute gut GVHD for identifying a patient population with a very poor outcome. Among 1462 patients who had allogeneic hematopoietic cell transplantation (HCT) between January 2000 and December 2005, 116 (7.9%) developed stage 3-4 gut GVHD. The median time for onset of stage 3-4 gut GVHD was 35 (4-135) days after allogeneic HCT. Eighty-five of the 116 patients (73%) had corticosteroid resistance before or within 2 weeks after the onset of stage 3-4 gut GVHD. Significant risk factors fo

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… dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease Blood 2007 109 4557 4563 17244684 10.1182/blood-2006-05-021139 4 Baehr PH Levine DS Bouvier ME Hockenbery DM Gooley TA Stern JG Oral beclomethasone dipropionate for treatment of human intestinal graft-versus-host … PA McDonald GB Deeg HJ Initial therapy of acute graft-versus-host disease with low-dose prednisone does not compromise patient outcomes Blood 2009 113 2888 2894 19001082 10.1182/blood-2008-07-168401 PMC2662636 8 Castilla C Perez-Simon JA Sanchez-Guijo FM Diez-Campelo M Ocio E Perez-Persona E Oral beclomethasone …

Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: the TRIVERSYTI randomised controlled trial.

BACKGROUND: A single-inhaler extrafine triple combination of beclometasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) has been developed for maintenance therapy of chronic obstructive pulmonary disease (COPD). This study evaluated the efficacy and safety of BDP/FF/G in patients in three eastern Asian areas: China, Republic of Korea and Taiwan. METHODS: TRIVERSYTI was a double-blind, randomised, active-controlled, parallel-group study in patients with COPD, post-bronchodilator forced expiratory volume in 1 s (FEV1) < 50% predicted, ≥ 1 exacerbation in the previous 12 m

[Extrinsic allergic alveolitis. Clinical experience at the Instituto National de Enfermedades Respiratorias (INER)].

Extrinsic allergic alveolitis is an interstitial lung disease caused by exposure to a variety of inhaled antigens. In Mexico, the most frequent form is due to the inhalation of avian antigens, markedly pigeon proteins. Depending on type and time exposure, the disease presents different clinical forms usually characterized by progressive dyspnea, ground glass or reticulonodular images on chest x rays, a restrictive functional pattern, rest hypoxemia worsening with exercise, and increase of T lymphocytes in bronchoalveolar lavage with an inversion in the helper/suppressor ratio. In this paper, w

Bronchial mucosal immunoreactivity of sensory neuropeptides in severe airway diseases.

Neuropeptides act on most of the components of the bronchial environment. They influence bronchomotor tone and bronchial vascular caliber and permeability. To investigate the nonadrenergic, noncholinergic system within the airways in asthma and chronic bronchitis, we performed endobronchial biopsies in 16 normal human volunteers, 49 patients with asthma of varying severity, including 16 patients treated with oral corticosteroids, and 13 patients with chronic bronchitis. Frozen sections of biopsies stained with specific antibodies against the neural marker PGP 9.5, vasoactive intestinal peptide

Real-World Effectiveness and Safety of Extrafine Triple Therapy in COPD Patients with Comorbid and Cardiovascular Conditions.

PURPOSE: This study evaluated the real-world effectiveness and safety of extrafine single-inhaler triple therapy (SITT) with beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB) in chronic obstructive pulmonary disease (COPD) patients with diverse comorbidity burdens, cardiovascular (CV) history, or CV risk. PATIENTS AND METHODS: A pooled analysis of six observational studies assessed outcomes in subgroups with 1-2 or ≥3 comorbidities, CV history, or CV risk. Endpoints included COPD Assessment Test (CAT) scores, exacerbation, lung function (FEV1), adherence (TAI-1

Maternal asthma medication use and the risk of selected birth defects.

OBJECTIVES: Approximately 4% to 12% of pregnant women have asthma; few studies have examined the effects of maternal asthma medication use on birth defects. We examined whether maternal asthma medication use during early pregnancy increased the risk of selected birth defects. METHODS: National Birth Defects Prevention Study data for 2853 infants with 1 or more selected birth defects (diaphragmatic hernia, esophageal atresia, small intestinal atresia, anorectal atresia, neural tube defects, omphalocele, or limb deficiencies) and 6726 unaffected control infants delivered from October 1997 throu

Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades.

We have used a non-myeloablative conditioning regimen for allogeneic hematopoietic cell transplantation for the past twenty years. During that period, changes in clinical practice have been aimed at reducing morbidity and mortality from infections, organ toxicity, and graft-versus-host disease. We hypothesized that improvements in clinical practice led to better transplantation outcomes over time. From 1997-2017, 1,720 patients with hematologic malignancies received low-dose total body irradiation +/- fludarabine or clofarabine before transplantation from HLA-matched sibling or unrelated donor

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… Topically-active glucocorticoids such as beclomethasone dipropionate were introduced which, when given with prednisone to patients with gastrointestinal GvHD in a randomized, placebo-controlled trial, allowed for a rapid taper of prednisone dosing starting 10 days after initiation, significantly reduced … A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft- versus -host disease. Blood. 2007;109(10):4557-4563. 4. Ruutu T, Eriksson B, Remes K, et al. …