BackgroundThe inhaled corticosteroid (ICS) fluticasone propionate (fluticasone) and the long-acting β2-agonist (LABA) formoterol fumarate (formoterol) are being made available as a combination product (fluticasone/formoterol, flutiform®) in a single aerosol inhaler. This 12-week, open-label, randomized, active-controlled, parallel-group, multicentre, phase 3 study compared the efficacy and safety of fluticasone/formoterol with the commercially available combination product fluticasone/salmeterol.MethodsPatients aged ≥ 18 years (N = 202) with mild-to-moderate–severe, persistent asthma for ≥ 6 months prior to screening were included in the study. After a screening phase (4–10 days), eligible patients were randomized 1:1 to receive fluticasone/formoterol or fluticasone/salmeterol during the 12-week treatment period. The primary objective was to demonstrate non-inferiority of fluticasone/formoterol versus fluticasone/salmeterol, measured by pre-dose forced expiratory volume in the first second (FEV1), at week 12.ResultsFluticasone/formoterol was comparable to fluticasone/salmeterol for the primary efficacy endpoint, mean pre-dose FEV1 at week 12. The new combination was also comparable to fluticasone/salmeterol for change from baseline to week 12 in pre-dose FEV1, change from pre-dose FEV1 at baseline to 2-hour post-dose FEV1 at week 12 and discontinuations due to lack of efficacy. Importantly, fluticasone/formoterol was superior to fluticasone/salmeterol in time to onset of action throughout the duration of the study. The two treatments demonstrated similar results for various other secondary efficacy parameters, including other lung function tests, patient-reported outcomes, rescue medication use, asthma exacerbations and Asthma Quality of Life Questionnaire scores. Fluticasone/formoterol was well tolerated and had a good safety profile that was similar to fluticasone/salmeterol.ConclusionsThe results of this study indicate that fluticasone/formoterol is as effective as fluticasone/salmeterol, and has a more rapid onset of action, reflecting the faster bronchodilatory effects of formoterol compared with those of salmeterol. If patients perceive the benefits of therapy with fluticasone/formoterol more rapidly than with fluticasone/salmeterol, this could have a positive impact on preference and adherence.Trial RegistrationClinicalTrials.gov: NCT00476073
This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers. Fluticasone/formoterol (500/20 μg, b.i.d.) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinically important parameters.
Pharyngeal pH monitoring confirmed LPR in 83.33% selected group of patients with chronic hoarseness and RSI ≥ 13. Isolated erythema of arytenoid and interarytenoid region was the most frequent inflammatory abnormality found in the larynx. RFS values below 7 do not exclude the diagnosis of LPR. We can use RFS scales as a prognostic test of severity of LPR - due to statistically significant positive correlation between Ryan score and RFS values. The use of RSI scale revealed that the most frequent symptom among patient with LPR was throat clearing followed by hoarseness.
Introduction and Objectives Some children with severe chronic asthma require long-term oral corticosteroids (OCS) to maintain disease control which places them at risk of potentially serious adverse effects. Omalizumab is a recombinant, humanised, monoclonal anti-IgE antibody indicated in the EU for use in patients of $6 years of age with inadequately controlled severe allergic asthma. This agent improves disease control in children, adolescents and adults. We conducted an observational survey in UK clinical centres to evaluate whether omalizumab enabled reduction of OCS dose in children with severe, persistent, allergic asthma. Methods Seven UK clinical centres were identified in which children (6 to <12 years of age) with severe persistent allergic asthma were being treated with omalizumab. Lead clinicians at each centre were approached to request their participation and, if they agreed, they were sent a short questionnaire. Participating clinicians provided information on children who had continued treatment with omalizumab beyond the 16-week responder assessment. Information collected included the number of children receiving omalizumab, OCS use, OCS dose at omalizumab initiation, numbers of children stopping, reducing or increasing OCS use, and current OCS doses. Results Information was provided from four sites for 18 children receiving omalizumab, all of whom were on maintenance OCS at baseline. All patients were able to stop or reduce their OCS dose after initiating omalizumab. Four patients (22%) on a mean baseline OCS dose of 8.8 mg/day stopped using OCS altogether. In the remaining fourteen patients (78%) the OCS dose was reduced by a mean of 15.4 mg (from 22.0 mg to 6.5 mg; mean 70.2% reduction). The mean dose reduction across all patients of 77% was achieved in a mean time of 14.6 weeks. Conclusions In this observational survey, all paediatric patients with severe allergic asthma who were commenced on omalizumab were able to stop or reduce OCS use, potentially reducing the risk of OCS-related adverse effects. The reductions in OCS use occurred over a short period, raising the possibility that further reductions in OCS dose might be feasible in some patients over a longer period of time.
The preliminary results suggest the potential use of the NOFA in ENT practice. Further studies are necessary to evaluate the usefulness of this device in the diagnosis of patients with upper respiratory tract disorders.
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