Efficacy and safety of fluticasone/formoterol combination therapy in patients with moderate-to-severe asthma

Background: The inhaled corticosteroid, fluticasone propionate, and the long-acting b2-adrenergic agonist, formoterol fumarate, are both highly effective treatments for bronchial asthma. This study (NCT00393952/EudraCT number: 2006-005989-39) compared the efficacy and safety of fluticasone/formoterol combination therapy (flutiform®; 250/10 mg) administered twice daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250 mg b.i.d.; formoterol 10 mg b.i.d.), in adult and adolescent patients with moderate-to-severe asthma. Methods: This was a 12-week, double-blind, randomised, parallel-group, multicentre, placebocontrolled phase 3 study. The co-primary efficacy endpoints were: i) the mean change in the forced expiratory volume in the first second (FEV1) from morning pre-dose at baseline to pre-dose at week 12 (fluticasone/formoterol 250/10 mg vs. formoterol), ii) the mean change in FEV1 from morning pre-dose at baseline to 2 h post-dose at week 12 (fluticasone/formoterol 250/10 mg vs. fluticasone), and iii) the number of patients who discontinued prematurely due to lack of treatment efficacy (fluticasone/formoterol 250/10 mg vs. placebo). The secondary endpoints included measures of lung function, disease control, and asthma symptoms. Safety was assessed based on adverse events, vital signs, and clinical laboratory evaluations. Results: Overall, 395 (70.9%) patients completed the study. Fluticasone/formoterol 250/10 mg b.i.d. was superior to the individual components and placebo for all three co-primary endpoints and demonstrated numerically greater improvements for multiple secondary efficacy analyses. Fluticasone/formoterol combination therapy had a good safety profile over the 12 weeks. Conclusion: Fluticasone/formoterol combination therapy will provide clinicians with an efficacious alternative treatment option for patients with moderate-to-severe asthma

Asthma in emergency departments: Combined adult and paediatric versus paediatric only centres

Objective: To compare the management of paediatric patients with mild or moderate asthma in paediatric-only emergency departments (POEDs) to treatment in a mixed adult-child emergency departments (mixed EDs). Methods: Prospective, observational study conducted in 36 Australian emergency departments (EDs) for 2 weeks in 2001. Children aged 1–15 years with acute asthma classified as mild or moderate severity. Details of demography, severity assessment, and type of treatment facility, treatment and disposition were collected. Analysis used descriptive statistics, comparison of proportions by χ2, and multiple logistic regression. Results:Two-hundred and nine children were treated at POEDs and 257 at mixed EDs. The groups had similar severity. Spacers to deliver beta-agonists were used more frequently in POEDs (67.5% vs 24.2%; P < 0.01). Children treated at POEDs with a mild attack were more likely to be admitted (20.6% vs 9.5%; P < 0.02) and given salbutamol (82.8% vs 71.9%; P = 0.03). For children with moderate asthma, oral steroid prescription on hospital discharge was more common for those treated in a mixed ED (81.0% v 95.7%; P= 0.01). Ipratropium bromide (IB) was widely used at both types of ED but more commonly used in mixed EDs (41.7% vs 54.9%; P < 0.01). There were no differences in length-of-stay, representation rate within one month and oral steroid use for attack. Less than 2/3 of children with mild asthma attacks received steroid treatment in the ED. Conclusion: Treatment was similar between the two types of ED. IB was overused in mild asthma and oral steroids were underused in moderate asthma, by both ED types. Spacers were under-utilized in mixed EDs

Adjustable maintenance dosing with budesonide/formoterol in a single inhaler - efficacy and safety

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Symptoms, spirometry, exhaled nitric oxide, and asthma exacerbations in clinical practice

Background: Patient symptoms, spirometry measurements, exacerbation rates, and exhaled nitric oxide (FENO) levels have all been used to quantify asthma severity.Objective: To determine the relationships among these disease Surrogates in clinical practice.Methods: Data were collected from 5 primary care asthma clinics on patient symptoms, reliever use, spirometry measurements, maintenance pharmacotherapy, disease severity (British Thoracic Society treatment step), and FENO level. Exacerbation data (asthma-related unscheduled health care contact or rescue oral corticosteroid therapy) for the 12 months before and 3 months after the clinic visit were then obtained.Results: A total of 267 adult asthmatic patients (mean [SEM] age, 51.6 [1.1] years; forced expiratory volurne in 1 second, 86.3% [1.2%] of predicted) participated, and 157 exacerbations were captured. For the 12 months before the clinic visit, exacerbation rate was positively correlated with dose of inhaled corticosteroid (P &lt;.001), treatment step (P &lt;.001), reliever use (P =.002), and symptom score (P &lt;.001) but was negatively correlated with FENO level (P =.04); only symptom scores correlated with exacerbation rate in the 3 months after the visit. Levels of FENO were significantly lower in frequently exacerbating patients receiving higher doses of maintenance inhaled corticosteroids compared with patients with mild disease who were corticosteroid naive (19.7 vs 40.4 ppb, P &lt;.001). Measurement of FENO was an insensitive method (sensitivity, 66.7%; specificity, 51.9% at a cutoff value of 20 ppb) for identifying patients who subsequently exacerbated.Conclusion: Levels of FENO are paradoxically decreased in patients with more severe asthma and frequent exacerbations and may, therefore, be of limited utility in primary care.</p