Pulmonary pharmacology & therapeutics
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Pulm Pharmacol Ther · Jan 2008
Randomized Controlled Trial Comparative StudyComparison of twice-daily inhaled ciclesonide and fluticasone propionate in patients with moderate-to-severe persistent asthma.
To investigate the relative efficacy of ciclesonide and fluticasone propionate (FP) administered at comparable microgram doses in maintaining asthma control in patients with moderate-to-severe persistent asthma. ⋯ Ciclesonide 320 microg and FP 330 microg administered twice daily over 6 months provided similar efficacy in patients with moderate or severe persistent asthma previously well-controlled by high doses of ICS at baseline. Ciclesonide was associated with fewer local AEs than FP.
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Pulm Pharmacol Ther · Jan 2008
Randomized Controlled Trial Multicenter Study Comparative StudyComparable spirometric efficacy of tiotropium compared with salmeterol plus fluticasone in patients with COPD: a pilot study.
International guidelines recommend the long-acting anticholinergic, tiotropium, or long-acting beta 2-agonists as maintenance therapy in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). The efficacy of long-acting beta(2)-agonists combined with inhaled corticosteroids (ICS) in the treatment of COPD has also been confirmed for severe and very severe COPD, but data comparing tiotropium with the combination of a long-acting beta 2-agonist and an ICS are lacking. ⋯ Six weeks of treatment with tiotropium resulted in comparable bronchodilation compared with salmeterol plus fluticasone in patients with moderate-to-very severe COPD, despite tiotropium patients having lower lung function and fewer patients considered reversible at baseline. The results of this pilot study will aid planning for further large-scale comparative studies.
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Pulm Pharmacol Ther · Jan 2008
Randomized Controlled Trial Multicenter StudyComparable long-term safety and efficacy of a novel budesonide/formoterol pressurized metered-dose inhaler versus budesonide/formoterol Turbuhaler in adolescents and adults with asthma.
Budesonide/formoterol in one inhaler is an established therapy for asthma and chronic obstructive pulmonary disease. The long-term safety and efficacy profile of a novel hydrofluoroalkane (HFA) pressurized metered-dose inhaler (pMDI) formulation of budesonide/formoterol was compared with that of budesonide/formoterol in a dry powder inhaler (DPI; Turbuhaler). This multinational, 52-week, randomized, open, parallel-group study included patients aged > or = 12 years with asthma who had a forced expiratory volume in 1s (FEV1)> or = 50% of predicted normal; all patients used inhaled corticosteroids (400-1200 microg/day) and needed additional short-acting beta 2-agonist therapy. ⋯ The proportion of patients discontinuing as a result of adverse events was low in both groups (pMDI 12/446 [3%], DPI 2/227 [1%]). Lung function was improved to a similar extent in both groups and there was no detectable difference in time to first severe asthma exacerbation. The novel HFA pMDI formulation of budesonide/formoterol is an equally well tolerated and effective treatment for adults and adolescents with asthma as the budesonide/formoterol DPI.
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Pulm Pharmacol Ther · Jan 2008
ReviewThe impact of inhaled corticosteroid and long-acting beta-agonist combination therapy on outcomes in COPD.
Chronic obstructive pulmonary disease (COPD) is an under-recognized cause of morbidity and mortality worldwide that imposes an ever increasing burden on the patient and society alike. The disease encompasses multiple structural and functional components of which inflammation is at the core of the disease, affecting the lungs and other organs. Consequently, current treatment strategies are aimed at treating both the symptoms and the pulmonary inflammation underlying the complex pathophysiology of COPD. Smoking cessation is the only intervention currently shown to slow disease progression in COPD and decrease all-cause mortality, aside from lung transplant, lung-volume reduction surgery and oxygen therapy in selective patients. However, this intervention is difficult to achieve and sustain because of the addictive and chronic relapsing nature of cigarette smoking. Pharmacotherapy with bronchodilating agents, including the beta 2-agonists, anticholinergics and methylxanthines, is central to the symptomatic management of all stages of COPD. While inhaled corticosteroids (ICS) are employed to reduce inflammation in more severe patients, their role as stand alone medication in COPD is not well defined. However, increasing evidence suggests that long-acting beta 2-agonists (LABAs) and ICS have complementary and synergistic effects, when delivered as combination therapy from a single inhaler. In this respect, two preparations comprising combinations of salmeterol+fluticasone propionate (SFC) and formoterol+budesonide (FBC) are currently available and employed for treatment of more severe disease. Several large-scale studies in patients with moderate-to-severe COPD have demonstrated that treatment with SFC and FBC leads to significantly greater improvements in lung function, exacerbations, health status and breathlessness, compared with placebo or monotherapy with the component drugs. In the recently published landmark study, Towards a Revolution in COPD Health (TORCH), regular treatment with SFC narrowly missed demonstrating a statistically significant benefit on the reduction in all-cause mortality over 3 years (17.5% reduction in risk, P=0.052), further emphasizing the clinical usefulness of LABA+ICS therapy in COPD. In view of this increasing evidence for the additional effectiveness of LABA+ICS combinations compared with the individual components, and the potential benefits of LABA+ICS on lung function, disease progression and potentially on all-cause mortality, initiation of LABA+ICS combination treatment early in the COPD disease process may be warranted. ⋯ The studies discussed in this review were identified from systematic searches of Medline and the Cochrane Database, up to October 2007, for articles in English or with English abstracts describing randomized, double-blind, parallel-group/crossover trials of at least 24 weeks' duration. All searches were performed using the terms: chronic obstructive pulmonary disease, COPD, chronic obstructive airway disease, or COAD AND either salmeterol, formoterol, long-acting beta 2-adrenoceptor agonist, fluticasone propionate, budesonide, inhaled corticosteroids, or inhaled glucocorticosteroids. Additional relevant references were identified from the reference lists of selected papers. Only studies that compared a combined LABA+ICS therapy with its monotherapy components were selected for inclusion in this manuscript.
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Pulm Pharmacol Ther · Jan 2008
Randomized Controlled TrialChronic inhalation of nebulized levalbuterol does not increase mucociliary clearance in healthy subjects.
Acute inhalations of beta 2-adrenergic receptor agonists increase mucociliary clearance (MCC). Less is known about the effect of long-term inhalations of these agents on MCC, or cough clearance (CC). We hypothesized that chronic inhalations of nebulized levalbuterol, the R-isomer of albuterol, would enhance MCC and/or CC in healthy subjects, compared to albuterol or placebo. ⋯ MCC averaged (+/-SD) 12.3+/-8.3%, 9.2+/-4.7% and 10.0+/-9.6% with placebo, albuterol and levalbuterol, respectively. CC averaged 3.9+/-6.8%, 4.9+/-4.3% and 3.8+/-6.4% with placebo, albuterol and levalbuterol, respectively. These results indicate that chronic inhalations of nebulized levalbuterol for 1 week do not increase MCC or CC in healthy subjects, compared to albuterol or placebo.