Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new pulmicort research articles will be listed here shortly after becoming available to us.
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Medical research on pulmicort
[Prevention of chronic obstructive pulmonary disease exacerbations.]
Presse Med. 2008 Sep 29;
Dusser D
Exacerbations of chronic obstructive pulmonary disease (COPD) aggravate disease course, induce increased morbidity and mortality, impair quality of life, and raise the direct costs of COPD. Their prevention is essential and is an integral part of the COPD program defined by French health authorities for the 2005-2010 period. Both pharmacologic and nonpharmacologic approaches have been shown to be effective in preventing exacerbations, but these treatments are still underused and misused. Important nonpharmacologic therapies that directly decrease the risk of exacerbation or hospitalization include smoking cessation, oxygen therapy, pulmonary rehabilitation, and education. Most of the drugs available for long-term management of COPD have significant effects on the frequency of exacerbations: tiotropium and salmeterol, each used alone, as well as fixed combinations of salmeterol/fluticasone or formoterol/budesonide. Tiotropium reduces the frequency of exacerbation in both moderate and severe COPD. Inhaled glucocorticosteroid agents are not recommended alone. They must be prescribed only with a long-acting bronchodilator and only to patients with severe disease and repeated exacerbations. Influenza vaccination is recommended.
Sustained Mechanical and Clinical Functionality of the Flexhaler() Dry Powder Inhaler.
J Aerosol Med Pulm Drug Deliv. 2008 Sep 29;
Lööf T, Elfman P, Ström P, Törngren A, Borgström L
Flexhaler() is a multiple-dose, inspiratory flow-driven dry powder inhaler that is a newer version of Turbuhaler((R)), and is identical to the Symbicort Turbuhaler ((R)). Sustained performance is of the utmost importance to ensure consistent drug delivery throughout the lifespan of the inhaler. We report functionality testing results of Flexhaler() inhalers used in two large-scale 12-week studies of budesonide (Pulmicort ((R))) and returned for testing. Functionality tests included measurement of airflow resistance and inspection of vital parts for the mechanical functionality of the inhaler, including visual inspection of the indicator wheel and function check of dose loading. In addition, delivered dose, particle size distribution, moisture content, and microbial counts were evaluated. Seven hundred sixteen out of 720 units were returned. Airflow resistance was not affected by the handling of the Flexhaler() inhalers during use (prior to use, average airflow resistance: 67 Pa(0.5)*s*L(1); returned inhalers: 66 and 67 Pa(0.5)*s*L(1) in each study, respectively. The average dose delivered remained as intended after prolonged clinical use [95% (range 88-103%) vs. reference of 99% (range 93-104%) before issue]. Relative fine particle dose (
Ann Allergy Asthma Immunol. 2008 Sep; 101(3): 295-303
Kaiser H, Parasuraman B, Boggs R, Miller CJ, Leidy NK, O'Dowd L
BACKGROUND: Onset of bronchodilation of budesonide/formoterol in one pressurized metered-dose inhaler (pMDI) has not been evaluated in asthma. OBJECTIVE: To evaluate time to onset of clinically significant bronchodilation (> or = 15% improvement in forced expiratory volume in 1 second) and patient-perceived onset of effect (OE) in patients previously receiving inhaled corticosteroids. METHODS: In two 12-week studies, patients 12 years and older with moderate to severe (study 1; n = 596) and mild to moderate (study 2; n = 480) persistent asthma received budesonide/formoterol pMDI, budesonide pMDI plus formoterol dry powder inhaler (study 1 only), budesonide pMDI, formoterol dry powder inhaler, or placebo. Postdose time to 15% or greater improvement in forced expiratory volume in 1 second and patient-perceived OE were evaluated. RESULTS: More budesonide/formoterol-treated patients achieved onset of clinically significant bronchodilation within 15 minutes (median, 13 minutes) of administration at randomization vs those taking budesonide or placebo (P < .001). More patients receiving budesonide/formoterol vs budesonide and placebo reported feeling their study medication begin to work right away (P < or = .004; end of week 1). Similar results (P < .001) were observed for patient satisfaction with how quickly they felt their medication begin to work (except budesonide/formoterol vs budesonide, study 1 [P = .073]). Time to onset of clinically significant bronchodilation and patient-perceived OE of budesonide/formoterol and formoterol were similar. CONCLUSION: Budesonide/formoterol demonstrated a more rapid onset of clinically significant bronchodilation and a greater percentage of patients who perceived their medication working right away vs budesonide or placebo.
[Nebulized corticosteroids and pediatricians: Results of the NUAGES survey.]
Arch Pediatr. 2008 Sep 18;
Salles M, de Monte M, Dubus JC, Diot P,
INTRODUCTION: The aim of the study was to analyze the data of the NUAGES survey (a survey on the practice of nebulization in France), concerning the prescriptions of nebulized steroids from 514 pediatricians. MATERIAL AND METHODS: The reason why nebulization was chosen as a delivery route, the diseases motivating the prescription, the age of the patients, the kind of drug used, and the prescription and device modalities were studied. RESULTS: Efficacy in treating various respiratory diseases was the main reason cited for using nebulization, in particular severe persistent asthma (76%). Pediatricians prescribed nebulization mainly to infants (60%). The most frequently used drug was budesonide suspension (89%), but the intravenous route for steroids (18%) and drug admixtures (62%) were also proposed by nebulization. A specific prescription for the nebulizer was given in 75% of the cases, with the type of interface to use specified in 66%. DISCUSSION: Pediatricians consider that nebulization is well adapted to young children. Although the proper steroid is usually chosen, unfortunately, it is often prescribed with other drugs, with 1 prescription out of 4 not following the recommendations. Prescription of the device is not optimal and may compromise the efficacy of the treatment. CONCLUSION: Nebulization is a potential mode of delivery for steroids that is difficult to prescribe and warrants improved pediatrician training.
Int J Pharm. 2008 Aug 30;
Varshosaz J, Emami J, Tavakoli N, Fassihi A, Minaiyan M, Ahmadi F, Dorkoosh F
Budesonide is a potent glucocorticoid with high affinity for the glucocorticoid receptor, which is now used for the treatment of inflammatory bowel diseases. Current oral formulations of budesonide present low efficacy against ulcerative colitis because of the premature drug release in the upper part of the gastrointestinal tract. The objective of this study was to develop a colon specific delivery system for budesonide to increase the efficacy in the treatment of ulcerative colitis. Dextran-budesonide conjugates were prepared with different molecular weights (MW) of dextran (10,000, 70,000 and 500,000) in the presence of dimethylaminopyridine (DMAP) using succinate spacer. The conjugates were characterized by (1)H NMR and IR spectroscopy and elemental analysis. The degree of substitution, aqueous solubility and chemical stability of conjugates in HCl 0.1N, phosphate buffer solutions pH 6.8 and 7.4 were studied. Drug release characteristics of the conjugates were also studied in the presence of the luminal contents of different segments of the rat gastrointestinal tract. Degree of substitution (DS) was dependent on the polymer MW and was 19.33, 14.29 and 11.60mg/100mg conjugate for MW 10,000, 70,000 and 500,000, respectively. Solubility of the drug in conjugates of MW 10,000 and 70,000 was increased with respect to the free drug and was dependent on DS. The three conjugates were found to be stable in HCl 0.1N, phosphate buffer solutions pH 6.8 and 7.4 incubated at 37 degrees C within 6h and the rate constants for degradation of conjugates to budesonide and budesonide hemisuccinate were less than 0.006h(-1). Less than 10% of the drug was released in contents of the stomach and small intestine, while about two-fold increase was observed after incubating the conjugates with colonic luminal contents. Conjugate prepared by dextran 70,000 showed the most desirable solubility, stability and release properties and could therefore be evaluated in vivo, for potential clinical use in the treatment of ulcerative colitis.
Int J Clin Pract. 2008 Sep 17;
Aballéa S, Cure S, Vogelmeier C, Wirén A
Aims: This retrospective, observational cohort study aimed to compare treatment outcomes and healthcare costs in the year after initiation of maintenance treatment with budesonide/formoterol or salmeterol/fluticasone in a German healthcare setting. Methods: Data on German asthma patients initiating treatment with budesonide/formoterol or salmeterol/fluticasone between June 2001 and June 2005 were obtained from the IMS Disease Analyzer database. The primary outcome was the probability of treatment success, defined according to short-acting beta(2)-agonist prescriptions and switches or addition of controller medications, during the postindex year. A secondary definition of treatment success included hospitalisations and oral corticosteroid (OCS) prescriptions. Secondary outcomes included severe asthma exacerbations, defined as >/=1 OCS prescription, asthma-related hospitalisation and/or referral. The effect of treatment on costs was estimated using generalised linear models, adjusting for patient and physician characteristics. Results: There were no significant differences between the budesonide/formoterol (n = 1456) and salmeterol/fluticasone (n = 982) groups in disease severity markers in the pre-index year. Patients on budesonide/formoterol had a 44% greater probability of treatment success [odds ratio (OR): 1.44; p = 0.0003] according to the primary definition and a 26% greater probability (OR: 1.26; p = 0.0119) according to the secondary definition, fewer severe exacerbations (-33.4%; p = 0.0123) and fewer OCS prescriptions (-31.5%; p = 0.0082) compared with salmeterol/fluticasone, after controlling for baseline characteristics. Adjusting for covariates, budesonide/formoterol had a significant inverse relationship on asthma-related costs compared with salmeterol/fluticasone (-13.4%; p < 0.001). Total cost (asthma- and non-asthma-related costs) was 12.6% lower for budesonide/formoterol (p < 0.0001). Conclusion: This study suggests that for patients with chronic asthma in Germany, budesonide/formoterol rather than salmeterol/fluticasone had a higher likelihood of treatment success, and that budesonide/formoterol is the less costly option. Although the cohorts appeared to be well matched at baseline, the results should be interpreted with caution given the observational nature of the study.
Combination therapy in asthma: a review.
Niger J Med. 2008 Jul-Aug; 17(3): 238-43
Saleh JA
BACKGROUND: Asthma can be defined as a chronic inflammatory disease of the airways that is reversible either spontaneously or by treatment. Despite the exponential increase in asthma research, the prevalence of asthma is on the increase, especially in children and young adults in the western societies. Inhaled therapies are the mainstay of asthma management. This is often in the form of combined therapy using two drugs in a single device to ensure adjustable maintenance dosing. METHOD: Relevant literature was reviewed using available medical journals, MEDLINE, Pubmed and Science direct via the Internet. The key words employed were: asthma, combination therapy, long acting beta agonists and corticosteroids. British Thoracic Society and The National Heart, Lung and Blood Institute websites were also used in sourcing information. RESULTS: Several studies have shown that combination therapy using long acting beta agonists (LABA) and inhaled corticosteroids (ICS) in a single inhaler device confers complementary and synergistic effect in the management of asthma. It further improves patient compliance and reduces the complexity of treatment and morbidity associated with the disease. Recent studies have shown the combination therapy to serve not only as maintenance but also a reliever therapy with same efficacy as the short acting beta agonists (SABA). CONCLUSION: This review was able to show the advantages of using combination therapy in asthma patients. This has been a subject of review at both national and international levels as there is no single medication that is effective against both the inflammatory and bronchoconstrictive components of this disorder. Recent studies have shown that Budesonide/formoterol in a single inhaler has been found to be effective maintenance and reliever agent in both adults and children. It has also been found to be safe and more efficacious than fixed-dosing. In addition to convenience and patient compliance, combination devices also help towards individualized approach to asthma management and reduce the complexity of treatment; this appears ideal for adoption by the primary care physician with a view for the patient to effectively achieve control of his own condition.
Pharmacokinetics of a novel submicron budesonide dispersion for nebulized delivery in asthma.
Int J Pharm. 2008 Aug 22;
Shrewsbury SB, Bosco AP, Uster PS
The objective of this study was to evaluate the safety and pharmacokinetics of unit dose budesonide (UDB), an aqueous dispersion of submicron-sized budesonide particles, and a commercially available budesonide suspension formulation. This was a randomized, double-blind, active-controlled, 4-period, 4-way crossover trial in 16 healthy, adult volunteers. Subjects received UDB 0.24, 0.12, and 0.06mg or commercial budesonide 0.25mg via a jet nebulizer. T(max) was significantly (p
Allergy. 2008 Oct; 63(10): 1292-300
Derendorf H, Meltzer EO
Intranasal corticosteroids (INSs) are effective treatments for allergic rhinitis, rhinosinusitis, and nasal polyposis. In recent years, increased understanding of corticosteroid and glucocorticoid receptor pharmacology has enabled the development of molecules designed specifically to achieve potent, localized activity with minimal risk of systemic exposure. Pharmacologic potency studies using affinity and other assessments have produced similar rank orders of potency, with the most potent being mometasone furoate, fluticasone propionate, and its modification, fluticasone furoate. The furoate and propionate ester side chains render these agents highly lipophilic, which may facilitate their absorption through nasal mucosa and uptake across phospholipid cell membranes. These compounds demonstrate negligible systemic absorption. Systemic absorption rates are higher among the older corticosteroids (flunisolide, beclomethasone dipropionate, triamcinolone acetonide, and budesonide), which have bioavailabilities in the range of 34-49%. Studies, including 1-year studies with mometasone furoate, fluticasone propionate, and budesonide that evaluated potential systemic effects of INSs in children have generally found no adverse effects on hypothalamic-pituitary-adrenal axis function or growth. Clinical data suggest no significant differences in efficacy between the INSs. Theoretically, newer agents with lower systemic availability may be preferable, and may come closer to the pharmacokinetic/pharmacologic criteria for the ideal therapeutic choice.
Arerugi. 2008 Aug; 57(8): 1034-42
Tezuka J, Motomura C, Ikei J, Ide K, Kando N, Goto M, Taba N, Hayashi D, Murakami Y, Moriyasu Y, Soebijanto K, Shibata R, Okada K, Okada H, Nishima S
OBJECTIVE: This study evaluated the efficacy and safety of Budesonide Inhalation Suspension (BIS) nebulazation by mesh nebulizer in children ages 6 months to 4 years with moderate to severe persistent asthma. METHOD: This 12-week, randomized, open study involved 30 asthmatic children. They were randomized 3 different nebulizer groups, Pari TurboBoy +LC Plus nebulizer, Pari eMotion and Omron MicroAir NE-22U. BIS administered 0.25 mg once daily (qd). Efficacy was assessed by daily card. Safety was assessed by adverse event, plasma cortisol and growth. RESULT: Baseline concentrations of plasma cortisol were significantly high in the group of Omron MicroAir NE-22U compared to other group. Plasma cortisol were decreased significantly at 4 weeks in Omron MicroAir NE-22U compared with baseline, but those in no subjects decreased under normal range. Asthma symptoms were improved significantly from baseline to 12-week. CONCLUSION: This study demonstrate that usage of mesh nebulizer in BIS 0.25 mg qd is effective and safe in young asthmatic children.