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Influence of salmeterol/fluticasone via single versus separate inhalers on exacerbations in severe/very severe COPD

Patients with severe or very severe chronic obstructive pulmonary disease (COPD) frequently suffer repeated exacerbations generating high health care utilization costs. Combined corticosteroid and bronchodilator treatment using a single inhaler might - via improved compliance - reduce exacerbation rates.

Objectives Our aim was to obtain descriptive data on exacerbation rates in patients with severe or very severe COPD (GOLD Stages III and IV as per GOLD 2009 classification) receiving salmeterol xinafoate/fluticasone propionate via a single inhaler (SFC) or via separate inhalers (Sal/FP) in addition to individual existing therapy in order to investigate the potential benefit of a fixed combination device as compared with two separate devices due to potentially improved patients' compliance.

Methods This prospective, randomized, open-label, parallel-group, multi-center, exploratory study was conducted in Germany in 2007–2009. Patients were required to have suffered ≥ 2 moderate/severe exacerbations in the preceding year.

Results 213 patients (SFC: 108 patients, Sal/FP: 105 patients) from 23 centers were evaluated. Approximately 25% of patients showed COPD Stage IV. On average patients had suffered 2.3 ± 0.6 moderate/severe exacerbations in the preceding year. The annual rate of moderate/severe exacerbations observed in the study was similar in both treatment groups (SFC: 0.86 ± 0.13; Sal/FP: 0.86 ± 0.14; exacerbation rate ratio SFC/Sal/FP: 1.00; p = 0.73; negative binomial model). Compliance was high and comparable in both groups. Besides COPD exacerbations, pneumonia (5.6%) and nasopharyngitis (5.2%) were the most common adverse events.

Conclusion Observed exacerbation rates were lower than those reported at baseline. No substantial difference was observed between administration of salmeterol xinafoate/fluticasone propionate via a single inhaler and separate inhalers. Treatment was safe and well tolerated.

Discordance between asthma control clinical, physiological and inflammatory parameters in mild asthma

Discrepancies have been observed between clinical, physiological, and inflammatory asthma control criteria, mostly in asthmatic subjects using regular inhaled corticosteroids (ICS) treatment.

This study compared the prevalence of discrepancies between these 3 control parameters in mild asthmatic subjects not taking ICS. Methods A retrospective analysis of demographic data and results from the Asthma Control Scoring System tool was performed in mild patients with asthma not taking ICS. The % score obtained for the clinical (symptoms), physiological (FEV1), and inflammatory (sputum eosinophil percentage) criteria were compared. Discrepancy was defined as a >20% difference between any 2 scores.

Findings Data from 213 subjects with mild asthma were analysed. Discrepancies between clinical and inflammatory scores were observed in 32% of subjects, whereas 31% showed discrepancies between physiological and inflammatory scores, and 20% between clinical and physiological scores. Sub-analysis of the discrepancy groups showed that respectively 88% and 89% of subjects had a higher clinical or physiological score than inflammatory score. Twenty-seven percent of subjects had residual airway inflammation despite adequate clinical control and optimal pulmonary function.

Interpretation There are significant discrepancies between scores of subjective and objective asthma control criteria. Airway inflammation often persists in subjects with good clinical or physiological asthma control scores. The consequences of this persisting airway inflammation in mild patients remain to be further studied.

Inhaler devices – From theory to practice

This brief overview of the factors determining lung deposition of aerosols provides background information required by health care providers when instructing patients to use their prescribed inhalers. We discuss differences in the optimal inhalation manoeuvres for each type of aerosol generator and the difficulties patients face.

Provision of short, clear instructions with demonstration of critical steps and checking technique during later clinical visits are necessary if these aerosolised medications are to be fully beneficial.

The effectiveness of physiotherapy in patients with asthma: A systematic review of the literature

Since the introduction of medical therapy for asthma the interest in non-medical treatments deteriorated. Physiotherapy could have beneficial effects in asthmatics. This review investigates the effectiveness of physiotherapy in the treatment of patients with asthma.

A review was performed on the terms breathing exercises (BE), inspiratory muscle training (IMT), physical training (PhT) and airway clearance (AC) in patients with asthma. The search resulted in 237 potentially relevant articles, after exclusion 23 articles remained. BE (n = 9) may improve disease specific quality of life (QoL), reduce symptoms, hyperventilation, anxiety and depression, lower respiratory rate and medication use. IMT (n = 3) can improve inspiratory pressure and may reduce medication use and symptoms. PhT (n = 12) can reduce symptoms, improve QoL and improve cardiopulmonary endurance and fitness.

In conclusion, physiotherapy may improve QoL, cardiopulmonary fitness and inspiratory pressure and reduce symptoms and medication use. Further studies, investigating combinations of techniques, are needed to confirm these findings.

Efficacy of theophylline plus salmeterol/fluticasone propionate combination therapy in patients with asthma

To compare the efficacy of theophylline plus salmeterol/fluticasone propionate combination product (SFC) with SFC plus placebo in asthmatic patients.

Methods In this randomized, stratified, parallel-group study, 325 patients were randomized to receive either 200 mg theophylline plus 50/250 μg SFC or placebo tablet plus 50/250 μg SFC twice daily for 24 weeks. Outcome variables included the level of asthma control (assessed by the Asthma Control Test) and the number of patients experiencing ≥1 exacerbations during the 24-week treatment period. Testing of lung function as well as measurement of the levels of inflammatory markers in induced sputum was performed.

Results There were significantly fewer patients with ≥1 asthma exacerbation in the theophylline plus SFC group (29.6%) when compared with the SFC plus placebo group (46.9%) (p = 0.004). Theophylline plus SFC improved the FEF25–75% value, which indicates enhanced small airway function, to a greater extent than SFC plus placebo (66.9 ± 18.8% and 57.4 ± 17.6%, respectively; p < 0.001). A significant decrease in eosinophil count and concentration of eosinophil cationic protein in induced sputum was also seen in the theophylline plus SFC group when compared with the SFC plus placebo group (4.1 ± 2.2% and 6.3 ± 2.7%, 63.6 ± 39.5 μg/L and 89.4 ± 45.6 μg/L, respectively; all p < 0.01).

Conclusion The combination of theophylline plus SFC may provide greater protection against asthma exacerbations, and its administration is accompanied by significant improvements in small airway function and airway inflammation.

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