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Archives of Disease in Childhood Aug 1986Two hundred and twenty nine children aged 6 to 15 years attending the asthma clinic at the Royal Hospital for Sick Children, Edinburgh, had throat swabs taken to...
Two hundred and twenty nine children aged 6 to 15 years attending the asthma clinic at the Royal Hospital for Sick Children, Edinburgh, had throat swabs taken to determine the incidence of candida colonisation of the oropharynx. One hundred children (group A), who were not receiving steroids, were compared with 91 children (group B) receiving less than 500 micrograms of inhaled beclomethasone a day and 38 children (group C) receiving 500 micrograms or more of inhaled beclomethasone a day. Sore throat and hoarse voice were not related to the presence of candida or to treatment with inhaled steroids. The incidence of candida was greater in the groups given treatment with steroids but did not increase at a higher dosage, nor was it related to the type of inhaler used. There was only one case of clinical thrush in all the children studied.
Topics: Adolescent; Beclomethasone; Candidiasis; Child; Dose-Response Relationship, Drug; Humans; Respiratory Therapy
PubMed: 3740927
DOI: 10.1136/adc.61.8.788 -
European Journal of Pharmaceutical... Apr 2023The correct use of dry powder inhalers by the patients is essential to ensure effective treatment and management of the disease. The purpose of the work was to assess...
The correct use of dry powder inhalers by the patients is essential to ensure effective treatment and management of the disease. The purpose of the work was to assess the consequence of inhaler misuse in terms of emitted dose and aerodynamic parameters. One reservoir multidose device (Foster-NEXThaler®) and one pre-dosed device (Relvar-Ellipta®), both sharing the "open, inhale and close" procedure, were the subject of the study. NEXThaler activated at different degrees of inclination showed a consistent dose delivery for both the drugs included in the formulation (beclometasone dipropionate/formoterol fumarate). Contrary, Ellipta showed a decrease of the emitted dose for both fluticasone furoate (FluF) and vilanterol trifenatate (VT) when the device was operated facing downward (-14% at 45° and -22% at 90°). Similarly, the delivered dose of NEXThaler was unaffected by an accidental fall, while Ellipta released FluF and VT doses 50% lower than control values. The presence of the dose protector in NEXThaler offers the advantage of retaining the powder if the inhaler is subjected to incorrect manipulations. Both products proved to be reliable in double activation. Finally, simulation exhalation conditions impaired, although not significantly, the aerodynamic profile of the two products.
Topics: Humans; Administration, Inhalation; Formoterol Fumarate; Beclomethasone; Dry Powder Inhalers; Pulmonary Disease, Chronic Obstructive; Bronchodilator Agents
PubMed: 36646153
DOI: 10.1016/j.ejps.2023.106385 -
British Medical Journal (Clinical... Feb 1983
Topics: Aerosols; Beclomethasone; Drug Administration Schedule; Humans
PubMed: 6402186
DOI: 10.1136/bmj.286.6365.644-e -
Canadian Medical Association Journal Jan 1973
Topics: Administration, Topical; Anti-Inflammatory Agents; Beclomethasone; Betamethasone; Fluocinolone Acetonide; Flurandrenolone; Glucocorticoids; Humans; Hydrocortisone; Immunosuppression Therapy; Pharmaceutic Aids; Skin; Triamcinolone
PubMed: 4682644
DOI: No ID Found -
British Journal of Clinical Pharmacology May 2001To assess the absolute bioavailability, pharmacokinetics and metabolism of beclomethasone dipropionate (BDP) in man following intravenous, oral, intranasal and inhaled... (Clinical Trial)
Clinical Trial Comparative Study
AIMS
To assess the absolute bioavailability, pharmacokinetics and metabolism of beclomethasone dipropionate (BDP) in man following intravenous, oral, intranasal and inhaled administration.
METHODS
Twelve healthy subjects participated in this seven-way cross-over study where BDP was administered via the following routes: intravenous infusion (1000 microg), oral (4000 microg, aqueous suspension), intranasal (1344 microg, aqueous nasal spray) and inhaled (1000 microg ex-valve, metered dose inhaler). The contribution of the lung, nose and gut to the systemic exposure was assessed by repeating the inhaled, intranasal and oral dosing arms together with activated charcoal, to block oral absorption. Blood samples were collected for 24 h postdose for the measurement of BDP, beclomethasone-17-monopropionate (B-17-MP) and beclomethasone (BOH) in plasma by liquid chromatography tandem mass spectrometry.
RESULTS
Intravenous administration of BDP (mean CL 150 l h-1, Vss 20 l, t(1/2) 0.5 h) was associated with rapid conversion to B-17-MP which was eliminated more slowly (t1/2 2.7 h). In estimating the parameters for B-17-MP (mean CL 120 l h-1, Vss 424 l) complete conversion of BDP to B-17-MP was assumed. The resultant plasma concentrations of BOH were low and transient. BDP was not detected in plasma following oral or intranasal dosing. The mean absolute bioavailability (%F, 90% CI; nominal doses) of inhaled BDP was 2% (1-4%) and not reduced by coadministration of charcoal. The mean percentage F of the active metabolite B-17-MP was 41% (31-54%), 44% (34-58%) and 62% (47-82%) for oral, intranasal and inhaled dosing without charcoal, respectively. The corresponding estimates of nasal and lung absorption, based on the coadministration of charcoal, were < 1% and 36% (27-47%), respectively.
CONCLUSIONS
Unchanged BDP has negligible oral and intranasal bioavailability with limited absorption following inhaled dosing due to extensive (95%) presystemic conversion of BDP to B-17-MP in the lung. The oral and intranasal bioavailabilities of the active metabolite B-17-MP were high and similar, but direct absorption in the nose was insignificant. The total inhaled bioavailability of B-17-MP (lung + oral) was also high (62%) and approximately 36% of this was due to pulmonary absorption. Estimates of oral bioavailability and pulmonary deposition based on total BOH were approximately half those found for B-17-MP.
Topics: Administration, Inhalation; Administration, Intranasal; Administration, Oral; Adult; Anti-Asthmatic Agents; Beclomethasone; Biological Availability; Cross-Over Studies; Humans; Male
PubMed: 11421996
DOI: 10.1046/j.0306-5251.2001.01374.x -
Clinical Gastroenterology and... Jul 2020Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND & AIMS
Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. Topical tacrolimus is effective and safe in patients with refractory UP. However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP.
METHODS
We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n = 43) or beclomethasone (3 mg; n = 42) for 4 weeks. The primary outcome was clinical response (decrease in Mayo score of 3 or more). Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. Outcomes were compared using Fisher's exact test and Mann-Whitney U test.
RESULTS
Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P = .812); proportions of patients in clinical remission were 46% and 38%, respectively (P = .638). Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P = .636); proportions in endoscopic remission rates were 30% and 13%, respectively (P = .092) Median increases in the inflammatory bowel disease questionnaire score were 18.0 in the tacrolimus group and 20.5 in the beclomethasone group (P = .395). Adverse event rates did not differ significantly between groups.
CONCLUSIONS
In a 4-week randomized controlled trial, tacrolimus and beclomethasone suppositories induce comparable clinical and endoscopic responses in patients with UP refractory to 5-ASA. There were no significant differences in adverse events rates. Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease. EUDRACT 2013-001259-11; Netherlands Trial Register NL4205/NTR4416.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerative; Female; Humans; Male; Mesalamine; Proctitis; Quality of Life; Suppositories; Tacrolimus
PubMed: 31610337
DOI: 10.1016/j.cgh.2019.09.049 -
The Cochrane Database of Systematic... 2001Beclomethasone dipropionate (BDP) is available in a wide range of daily doses for the treatment of long-term asthma. (Review)
Review
BACKGROUND
Beclomethasone dipropionate (BDP) is available in a wide range of daily doses for the treatment of long-term asthma.
OBJECTIVES
To assess the evidence for a dose response relationship for BDP in the treatment of long-term asthma.
SEARCH STRATEGY
We searched the Cochrane Airways Group trial register, Cochrane Controlled Trials Register (The Cochrane Library issue 1 1999) and references lists of articles. Authors and Glaxo Wellcome UK were contacted to identify eligible studies. We also hand searched the proceeding from relevant respiratory society meetings, the British Journal of Clinical Research and the European Journal of Clinical Research for studies.
SELECTION CRITERIA
Prospective, randomised trials comparing two or more daily doses of BDP in patients over the age of two years with long-term asthma.
DATA COLLECTION AND ANALYSIS
Trials were selected for inclusion and scored for quality by two reviewers. Data were extracted by one reviewer. Authors were contacted to clarify details of study design and retrieve missing data.
MAIN RESULTS
11 trials involving 1614 subjects were included. Methodological quality was variable. Studies rarely gave a clear indication of the degree of asthma control at baseline. Less than two-fold to five-fold dose differences were assessed by different studies. The results are reported as weighted mean differences (WMD) with 95% confidence limits (95% CI). The number of trials (N) contributing to each outcome is stated. In non-oral steroid treated asthmatics a small advantage of BDP 800 mcg/d over 400 mcg/d was apparent for improvement in morning peak expiratory flow rate (PEFR) compared to baseline, WMD 11 L/min (95% CI 4 to 19 L/min) N=2; improvement in forced expired volume in one second (FEV1) compared to baseline, WMD 9 ml (95% CI 3 to 140) N=1; and reduction in night-time symptom score compared to baseline, WMD 0.13 (95% CI 0.04 to 0.22) N=1. Studies that assessed BDP 1000 v 500 mcg/d and BDP 1600 v 400 mcg/d demonstrated significant advantage of higher dose over lower dose for histamine bronchial hyper-responsiveness (BHR) and percentage improvement in FEV1 compared to baseline. No differences between higher and lower daily doses of BDP were apparent for daytime symptoms, withdrawals due to asthma exacerbation, oropharyngeal side effects or measures of hypothalamo-pituitary-adrenal (HPA) function. No difference in prednisolone sparing effect was apparent when comparing high dose and low dose BDP in oral corticosteroid (OCS) dependent patients.
REVIEWER'S CONCLUSIONS
BDP appears to demonstrate a shallow dose response effect in long-term asthma for a small number of efficacy outcomes over range of daily doses from 400 mcg/d to 1600 mcg/d, although the clinical significance of the improvements afforded by higher doses is questionable.
Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Dose-Response Relationship, Drug; Humans; Prospective Studies; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 11279769
DOI: 10.1002/14651858.CD002879 -
Biology of Blood and Marrow... Apr 2009For over a decade, nonabsorbable corticosteroids have been employed in the treatment of gastrointestinal graft-versus-host-disease (GVHD) in hematopoietic stem cell... (Review)
Review
For over a decade, nonabsorbable corticosteroids have been employed in the treatment of gastrointestinal graft-versus-host-disease (GVHD) in hematopoietic stem cell transplant (HSCT), as monotherapy or in combination with systemic corticosteroids. The majority of the evidence showing a favorable outcome consisted of case series, small phase II trials and a large randomized phase III trial. The 2 most commonly studied molecules were oral budesonide and beclomethasone diproprionate. Although these reports hint at some benefit with the local treatment strategy, their methodologic inconsistencies preclude meaningful adoption to everyday clinical practice. This review evaluates the current evidence of nonabsorbable corticosteroids in HSCT and sets forth recommendations for future trials with these agents.
Topics: Beclomethasone; Budesonide; Clinical Trials as Topic; Gastrointestinal Diseases; Glucocorticoids; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Treatment Outcome
PubMed: 19285626
DOI: 10.1016/j.bbmt.2008.12.487 -
Respiratory Medicine Jul 2010Few studies on the concomitant effects of beclomethasone dipropionate and asthma-related factors on the growth of prepubertal asthmatic children have been published to...
Few studies on the concomitant effects of beclomethasone dipropionate and asthma-related factors on the growth of prepubertal asthmatic children have been published to date. In this prospective long-term 'real-life' cohort study we recruited 82 prepubertal steroid-naïve asthmatic patients aged 3 + years, excluding those with birth weight lower than 2500 g, malnutrition, and other concurrent chronic diseases. Height/age and weight/age Z scores were calculated every three months. Random effects multivariate longitudinal data analysis was used to adjust height/age and weight/age Z scores with independent variables. Among the studied patients, 63.4% were male, aged 4.7 + or - 1.5 years, 68.3% suffered from severe persistent asthma and had normal values for height/age and weight/age Z scores at enrolment. They were followed for 5.2 years (range 2.3-6.1) and used a mean daily beclomethasone dipropionate dose of 351.8 mcg (range 137.3-1140.0). Height/age and weight/age Z scores were not affected by either duration of treatment or doses of beclomethasone dipropionate up to 500 mcg, 750 mcg and higher than 750 mcg (p-values > 0.17). The multivariate analysis final model showed that severe persistent asthma was associated to lower height for age Z score (p = 0.04), whereas hospitalizations because of acute asthma (before and during follow-up) were associated (p = 0.02) to lower weight for age Z score. Growth parameters were not affected by the use of beclomethasone dipropionate.
Topics: Administration, Inhalation; Anthropometry; Anti-Asthmatic Agents; Asthma; Beclomethasone; Brazil; Child; Child, Preschool; Female; Follow-Up Studies; Growth; Humans; Male; Multivariate Analysis; Prospective Studies; Time Factors
PubMed: 20189373
DOI: 10.1016/j.rmed.2010.02.002 -
Journal of Veterinary Internal Medicine 2006Glucocorticoid (GC) therapy is recognized to be effective for the treatment of recurrent airway obstruction (RAO) in horses. Anti-inflammatory properties of GC are... (Randomized Controlled Trial)
Randomized Controlled Trial
Effect of beclomethasone dipropionate and dexamethasone isonicotinate on lung function, bronchoalveolar lavage fluid cytology, and transcription factor expression in airways of horses with recurrent airway obstruction.
Glucocorticoid (GC) therapy is recognized to be effective for the treatment of recurrent airway obstruction (RAO) in horses. Anti-inflammatory properties of GC are thought to be mediated by suppression of inflammatory gene expression via inhibition of transcription factors such as nuclear factor-kappaB (NF-kappaB) and activator protein-1 (AP-1). The purpose of this study was to evaluate the effect of low-dose inhaled beclomethasone dipropionate and injectable dexamethasone 21-isonicotinate on clinical signs, pulmonary function, airway cytology, and activity of NF-kappaB and AP-1 in bronchial cells of RAO-affected horses. Seven horses with RAO were exposed to moldy hay until they developed airway obstruction on 3 separate occasions. In a crossover design, they were then treated with a placebo (injection on day 1), inhaled beclomethasone (500 microg q12h for 10 days), or dexamethasone (0.06 mg/kg, IM on day 1) and monitored for 10 days. Pulmonary function, bronchoalveolar lavage fluid cytology, and NF-kappaB and AP-1 activity in bronchial brushing cells were measured before (day 1) and after treatment (day 10). Treatment with beclomethasone resulted in significantly improved pulmonary function of RAO-affected horses compared with placebo and dexamethasone treatments. However, none of the treatments had an effect on bronchoalveolar lavage fluid cytology or NF-kappaB and AP-1 activity. These findings reveal that, in a model of severe RAO, the benefits of low-dose inhaled beclomethasone on pulmonary function are not accompanied by a decrease in airway inflammatory cells or a suppression of transcription factors NF-kappaB and AP-1 DNA-binding activity.
Topics: Animals; Anti-Inflammatory Agents; Beclomethasone; Bronchoalveolar Lavage Fluid; Cross-Over Studies; Dexamethasone Isonicotinate; Female; Gene Expression Regulation; Horse Diseases; Horses; Lung; Lung Diseases, Obstructive; Male; Respiratory Therapy; Transcription Factors
PubMed: 16594601
DOI: 10.1892/0891-6640(2006)20[399:eobdad]2.0.co;2