Effectiveness and Treatment Compliance of Salmeterol-Fluticasone Easyhaler® Among Patients with Asthma, COPD, or Asthma-COPD Overlap Syndrome: Real-World Study Findings.

INTRODUCTION: For inhalation therapies to be effective, it is crucial that patients manage inhaler use correctly in their everyday life and achieve treatment compliance. We investigated the effectiveness of the salmeterol-fluticasone propionate Easyhaler® (SF EH) device-metered dry powder inhaler in a real-world setting in Hungary among adult patients with asthma, chronic obstructive pulmonary disease (COPD), or asthma-COPD overlap syndrome (ACO). METHODS: A prospective, open-label, multicenter, noninterventional, investigator-sponsored study was conducted in outpatient pneumonology centers. Eligible patients were aged ≥ 18 years with either a new diagnosis of asthma, COPD, or ACO, or whose disease was not controlled with preexisting medication. Data were collected at baseline and 12 + 4 weeks, including the asthma control test (ACT), COPD assessment test (CAT), spirometry parameters [including forced expiratory volume for 1 s (FEV1)], and physician- and patient-reported outcomes. RESULTS: Five hundred sixteen patients were recruited from 103 centers: 376 with asthma; 104 with COPD; and 36 with ACO. At week 12, there were significant improvements from baseline in both mean ACT score in patients with asthma (14.4 ± 4.2 versus 21.4 ± 2.8; P < 0.001) and mean CAT score in patients with COPD (24.0 ± 6.1 versus 16.0 ± 5.8; P < 0.001). Significant improvement was observed when the switch from the most frequently used previous inhalers was analyzed separately. Mean FEV1 improved from 76.0% ± 17.2 to 84.7% ± 16.1 (P < 0.001) and from 53.8% ± 15.0 to 59.9% ± 15.0 (P < 0.001) in patients with asthma or COPD, respectively. The study demonstrated improved physician-rated overall treatment compliance and patient preference for the SF EH over 3 months use compared with previous inhaler treatment, with patients effectively adopting the SF EH into everyday life. CONCLUSIONS: Treatment with SF EH significantly improved patients' lung function parameters and disease control.

Inspiratory Flow Parameters Through Dry Powder Inhalers in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD): Device Resistance Does Not Limit Use in COPD.

INTRODUCTION: Achieving correct inhalation technique through an inhaler to ensure effective drug delivery is key to managing symptoms in patients with chronic obstructive pulmonary disease (COPD). However, many patients struggle to use their inhalers correctly, with the resultant reduction in therapeutic benefit. Consequently, appropriate inhaler choice is important to maximize clinical benefit. The primary objective of this study was to characterize inspiratory flow parameters across two Easyhaler® inhalers and the HandiHaler® inhaler in patients with COPD and healthy volunteers. METHODS: In this randomized, open-label, crossover study, subjects (100 patients with COPD; 100 healthy volunteers) were trained to perform inhalations of placebo powder via two variants of Easyhaler and placebo capsules via the HandiHaler inhalers. Subjects then performed three placebo inhalations through each inhaler in a random sequence. Inspiratory flow parameters were assessed, including peak inspiratory flow (PIF), for each inhaler. A parallel sub-study was conducted in patients with COPD from the main study to assess correct use of the inhalers, patient's preference, ability to learn to use the inhalers, and the feasibility of the In-Check Dial device to measure PIF values. RESULTS: Mean PIF rates and inspiratory volumes through the three inhalers were similar between patients with COPD and healthy volunteers, and all subjects achieved the 30 L/min PIF required for effective use of Easyhaler. Almost 70% of the 88 patients enrolled in the sub-study used the Easyhaler and HandiHaler inhalers without errors. The Easyhaler was preferred by 51% of patients, while 25% favored the HandiHaler. Teaching the use of both inhalers to almost 70% of patients was very easy. The In-Check Dial PIF values and those obtained via spirometry were strongly correlated (p<0.0001) for all three inhalers. CONCLUSION: The respiratory performance of patients with COPD does not appear to be a limiting factor in the use of Easyhaler.

The value of nasopharyngeal culture in predicting the etiology of acute otitis media in children less than two years of age.

BACKGROUND: In selecting treatment of acute otitis media (AOM), knowledge of its etiology would be valuable. We revisited the possibility to use the nasopharyngeal culture of Streptococcus pneumoniae (Pnc) and Haemophilus influenzae (Hi) for predicting their presence in the middle ear fluid (MEF) during AOM. METHODS: The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of bacterial culture of the nasopharyngeal aspirate (NPA) in predicting the presence of the same pathogen in the MEF were assessed during AOM events among children followed from 2 to 24 months of age. RESULTS: The data comprised 586 AOM events. For Pnc, the sensitivity and NPV were high, 99% (95% confidence interval = 95-100%) and >99% (97-100%), respectively. The specificity and PPV were relatively low, 63% (57-68%) and 50% (43-56%). For Hi, the sensitivity and the NPV were lower (77%, 69-83% and 93%, 90-95%) than for Pnc, but the specificity and the PPV were higher (88%, 85-91% and 64%, 56-71%). The quantity of Pnc and Hi in the NPA was clearly related to their presence in the MEF. If both Pnc and Hi were found in the nasopharynx, Hi was more likely cultured from MEF. CONCLUSION: Together with clinical and epidemiologic features of AOM, the nasopharyngeal culture can be helpful in selecting specific antimicrobial therapy.

Nasopharyngeal carriage of anaerobes during health and acute otitis media by two years of age.

The nasopharyngeal acquisition of anaerobic bacteria was longitudinally examined among a homogeneous group of Caucasian infants by 2 years of age. Nasopharyngeal swab (NP) samples were collected at scheduled healthy visits at 2, 6, 12, 18, and 24 months of age, and nasopharyngeal aspirates (NPA) during every visit for acute otitis media (AOM). The infants were divided into 4 groups according to the number (0, 1, 2-3, and > 3) of AOM episodes experienced by 2 years of age. At 2 years, the cumulative carriage rates of anaerobic species in these infant groups were 29%, 62%, 89%, and 89%, respectively. Anaerobic species were found in 15/220 (6.8%) of the NP samples and in 34/71 (47.9%) of the NPA samples. Our present results indicate that anaerobic species do not belong to the indigenous nasopharyngeal microflora but only transiently colonize the nasopharynx during AOM.

Viral etiology of frequently recurring respiratory tract infections in children.

The viral etiology of frequently recurring respiratory tract infection (FRRI) in children aged <2 years was studied. Altogether, 329 children were followed from 2 to 24 months of age in the Finnish Otitis Media Cohort Study. Children with FRRI were defined as having > or =9 episodes of upper respiratory tract infection (URI) and/or > or =4 episodes of acute otitis media during follow-up. Nasopharyngeal aspirates, middle ear fluid specimens, and serum samples were analyzed for 8 common respiratory viruses. Of 1358 URI episodes, 642 (47%) occurred in the 78 children with FRRI. At least 1 virus was associated with 62% of these episodes, whereas the corresponding figure for children without FRRIs was 54%. The frequency of different viruses was similar in both groups, but the relative proportion of rhinovirus infections was slightly higher among children with FRRI. In conclusion, a specific viral etiology does not explain the excess of URI episodes in children with FRRI.

Predicting the development and outcome of otitis media by tympanometry.

OBJECTIVE: Identification of children with high risk of development or prolongation of otitis media would be highly useful in clinical practice. In this study, tympanometry was assessed for its capability in predicting development and resolution of acute otitis media (AOM). METHODS: Visits of 329 children followed in the Finnish Otitis Media Cohort Study from 2 to 24 months of age were evaluated for this report. Tympanometry was routinely performed on all children during their visits to a special study clinic. Adjacent consecutive visits were used for analysis of development and resolution of middle ear fluid (MEF) between the visits. Descriptive analysis utilized all data obtained during the longitudinal follow-up; confirmatory statistical analysis was performed on data of one randomly selected visit per subject to ensure independence of observations. Presence of MEF at the second visit was used as the outcome. RESULTS: Negative tympanometric peak pressure (<-100 daPa) was found to predict the development of otitis media when observed during respiratory infection with no concomitant ear disease. Otitis media developed within 20 days to 40% of children with negative pressure compared with 20% of children without negative pressure. The observed association was confirmed statistically (odds ratio 4.8, 95% confidence interval 2.4-9.6). Poor outcome of AOM at the subsequent follow-up visit 3-5 weeks later was found in 9% of ears with negative pressure tympanogram compared with 24% with initial type B or normal pressure tympanogram during AOM. However, we could not confirm the finding in statistical analysis (odds ratio 0.6, 95% confidence interval 0.2-2.0). CONCLUSIONS: Profound negative tympanometric peak pressure is a significant marker of increased risk for development of otitis media. Children with negative pressure have to be thoroughly followed for subsequent progress of the respiratory disease and development of otitis media. For the prediction of resolution of AOM, the findings remained inconclusive.

Common respiratory infections early in life may reduce the risk of atopic dermatitis.

Infections that occur early in life may protect against atopic disease later in life. To investigate the relationship between common acute respiratory infections and atopic dermatitis in early childhood, we closely observed a cohort of 329 children from the ages of 2 to 24 months. We assessed the effect of proven viral infections and acute otitis media on the occurrence of atopic dermatitis. If the child had his or her first respiratory infection before the age of 6 months, the child's remaining risk of developing atopic dermatitis was reduced by 49% (95% confidence interval, -24% to 79%). The individual risk of developing atopic dermatitis was similarly reduced after infection experienced at >/=6 months of age, but the remaining risk was low, because most cases of atopic dermatitis had manifested by this time. Our results are consistent with the hypothesis that early infections may reduce the risk of atopic disease.