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To assess asthma-related quality of life after treatment with combination fluticasone propionate and salmeterol delivered via hydrofluoroalkane 134a metered-dose inhaler compared with the individual components alone.
The hypothesis of the study was that salmeterol and ipratropium would have similar dyspnoea ratings during steady-state cycle ergometry at 1 h, but that salmeterol would reduce dyspnoea at 6 h after administration in patients with chronic obstructive pulmonary disease (COPD). The study design was a randomized, double-blind trial in 16 patients (aged 63 +/- 11 yrs) with symptomatic COPD. Two days after familiarization with testing procedures, patients were randomly assigned to receive either two puffs (42 microg) of salmeterol and two puffs of placebo inhaler, or two puffs (36 microg) of ipratropium from each of two inhalers (total, 72 microg). Two days later, patients received the alternative medication. During exercise at 60% of peak oxygen consumption patients rated dyspnoea and performed inspiratory capacity manoeuvres each minute. Forced expiratory volume in one second was 1.13+/-0.48 L (37+/-13% predicted). Dyspnoea ratings were similar for salmeterol and ipratropium at 1 and 6 h. Inspiratory capacity was similar for salmeterol and ipratropium at 1 h, but significantly higher for salmeterol at 6 h (delta = 120 mL; p = 0.03). It is concluded that with the doses used, salmeterol and ipratropium provided similar dyspnoea ratings during exercise at 1 and 6 h after administration.
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Patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone. Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than did those in the fluticasone-only group. (AUSTRI ClinicalTrials.gov number, NCT01475721.).
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In both obese and non-obese subjects, fluticasone propionate combined with salmeterol was more effective in controlling asthma than fluticasone alone. However, for both treatments the odds of achieving well-controlled asthma were significantly lower in obese subjects, particularly among those with a BMI of >or=40 kg/m2. Reported prevalence of atopy increased with BMI. Age did not influence the effect of obesity in response to asthma medications.
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46 patients provided evaluable efficacy for analysis. The morning PEF improved significantly throughout the two weeks of treatment compared with baseline in the SAL/FP group. Mean morning PEF was 23.0 L/min higher in SAL/FP group than in FP group (p = 0.013). The change of forced expiratory volume in one second (FEV1) from baseline was greater in SAL/FP group compared to FP group (p = 0.048). There were similar effects on day-time and night-time symptom scores, percentage symptom free days and nights and usage of salbutamol. 70.8% of the patients receiving SAL/FP were satisfied with the treatment, while only 26.1% of patients receiving FP alone were (p = 0.020). No death or acute exacerbation occurred.
Over weeks 1 to 12, adjusted mean improvements in morning PEFR were 43 and 36 L/min for combination and concurrent therapies, respectively. The difference between the two treatment arms was 6 L/min (90% CI -13 to 0 L/min; P=0.114), which was within the predefined criteria for clinical equivalence. Adjusted mean improvements in forced expiratory volume in 1 s from baseline for week 28 were also similar between the two therapies. Thirty-five per cent of patients receiving combination inhaler and 31% of those receiving concurrent therapy had a mean daytime symptom score of zero over weeks 1 to 12 compared with 1% and 2%, respectively, at baseline. There was no difference in the incidence of adverse events between the two treatment arms. Mean serum cortisol levels were similar, and no differences in frequency of abnormal results were noted between the two groups.
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Rochester, New York.
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Asthmatics were stratified by ADRB2 genotype in two studies to assess the effects of inhaled corticosteroids plus longacting beta2-agonists on asthma exacerbations. In study 1 (double-blind), 2250 asthmatics were randomly assigned to budesonide plus formoterol maintenance and reliever therapy, fixed-dose budesonide plus formoterol, or fixed-dose fluticasone plus salmeterol for 6 months. Study 2 (open-label) consisted of 405 asthmatics and compared an adjustable regimen of budesonide plus formoterol with fixed-dose budesonide plus formoterol and fixed-dose fluticasone plus salmeterol for 7 months. The relation between ADRB2 polymorphism, severe asthma exacerbations, and other asthma outcomes was analysed. Primary endpoints for studies 1 and 2 were severe asthma exacerbation and asthma control as assessed by measures of exacerbations, respectively.
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Since the proportion of missing outcome data compared to the observed outcome data is enough to induce a clinically relevant bias in the intervention effect, the relative efficacy and safety of combined inhalers and tiotropium remains uncertain. Further large, long-term randomised controlled trials comparing combination therapy to tiotropium are required, including adequate follow-up of all participants randomised (similar to the procedures undertaken in TORCH and UPLIFT). Additional studies comparing alternative inhaled LABA/steroid combination therapies with tiotropium are also required.
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Long-acting beta(2)-agonists have acquired an indispensable position in the management of bronchial symptoms in patients with asthma. The objective of this study was to compare onset-of-action and clinical effectiveness of formoterol and salmeterol during 2 weeks of treatment. We also investigated the association between bronchodilator effects and perceived relieve of dyspnoea.
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The use of dry-powder inhalers (DPIs) to administer respiratory medicines is increasing, and new DPIs are likely to be developed because of expiring patents. However, there is considerable debate concerning the extent to which DPIs are interchangeable without altering disease control or the safety profile of the treatment.
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Twice-daily salmeterol aerosol, 42 microg, or placebo via metered-dose inhaler for 24 weeks. Backup albuterol was available.
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Asthmatic patients sensitized to pollen allergens were randomly allocated to monotherapy with salmeterol (n = 14) or placebo (n = 13).
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indacaterol is a novel, inhaled once-daily ultra-long-acting β(2)-agonist for the treatment of chronic obstructive pulmonary disease (COPD).
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No significant differences have been found in fatal or non-fatal serious adverse events in trials in which regular salmeterol has been randomly allocated with inhaled corticosteroids, in comparison to inhaled corticosteroids at the same dose. Although 10,873 adults and 1,173 children have been included in trials, the number of patients suffering adverse events is too small, and the results are too imprecise to confidently rule out a relative increase in all-cause mortality or non-fatal adverse events. It is therefore not possible to determine whether the increase in all-cause non-fatal serious adverse events reported in the previous meta-analysis on regular salmeterol alone is abolished by the additional use of regular inhaled corticosteroids. The absolute difference between groups in the risk of serious adverse events was small. There were no asthma-related deaths and few asthma-related serious adverse events. Clinical decisions and information for patients regarding regular use of salmeterol have to take into account the balance between known symptomatic benefits of salmeterol and the degree of uncertainty and concern associated with its potential harmful effects.
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We conclude that inhaled LABA therapy improves sleeping SaO(2) without significant change in sleep quality.
We investigated 10 nonsmoking subjects (8 men and 2 women; mean +/- SD age, 24 +/- 8 years) with mild intermittent allergic asthma in the stable phase of the disease, who were never previously treated with regular beta(2)-agonists. Subjects with a previous positive early airway response (EAR) to a screening allergen challenge were considered. They underwent sBPT with allergen after a single dose of inhaled salmeterol, 50 microg (T(1)), and then underwent sBPT after 1 week of regular treatment with inhaled salmeterol, 50 microg bid (T(2)); after that, they continued inhaled salmeterol treatment for 4 days, and then changed to inhaled salmeterol with placebo (two puffs bid) for 3 days (72 h) and underwent sBPT with allergen after a single dose of salmeterol, 50 microg (T(3)).
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Improved adherence to inhaled corticosteroids (ICSs) has also been associated with decreased asthma-associated morbidity and mortality.
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Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease in which patients experience a progressive decline in lung function. Based on clinical evidence, the management of COPD should focus on (1) earlier diagnosis; (2) risk reduction through smoking cessation, decreased exposure to inhaled irritants, and immunization against respiratory pathogens; (3) symptom reduction with pharmacotherapy and pulmonary rehabilitation; (4) decreasing complications by reducing exacerbations and improving pulmonary function; and (5) improving health-related quality of life (HRQOL). Smoking cessation has been shown to slow lung function decline and to reduce mortality--including deaths due to lung cancer, other respiratory disease (including COPD), and cardiovascular disease. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the American Thoracic Society and European Respiratory Society (ATS/ERS) guidelines advocate interventions according to the severity of COPD and recommend initiation of maintenance long-acting bronchodilator therapy in patients with moderate disease. However, recent evidence from a post hoc analysis of randomized controlled trials of tiotropium suggests that initiation of long-acting bronchodilator therapy at earlier stages of disease may also provide improvements in lung function and HRQOL. The results of ongoing long-term studies may soon provide evidence that in addition to relieving symptoms and improving patient HRQOL, specific pharmacologic therapies may also alter the clinical course of COPD.
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Forty-four studies including a salmeterol 100 microg treatment arm were identified. Data on predictable systemic effects were available in 10 single-dose and 9 chronic-dose studies lasting more than 7 days, in patients with asthma (6 adult, 2 pediatric) or chronic obstructive pulmonary disease (1 study), which were included in a weighted, pooled analysis.
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Long-term treatment studies with formoterol and salmeterol show that these inhaled long-acting beta 2-agonists compared to available beta 2-agonists produce better bronchodilation, decrease the need for additional doses, decrease asthma symptoms, and are strongly preferred by the patients. Development of tolerance has not been found. One case history indicates that these effective bronchodilators might mask deterioration of asthma.