Respiratory medicine
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Respiratory medicine · Sep 2014
Randomized Controlled TrialInitiation of home mechanical ventilation at home: a randomised controlled trial of efficacy, feasibility and costs.
Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-inferior to an in hospital based setting. ⋯ This study is the first to show that initiation of HMV at home in a selective group of patients with chronic respiratory failure is as effective for gas exchange and quality of life as hospital initiation. In addition we found that it is safe, technically feasible and that more than € 3000 per patient can be saved compared to our standard care.
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Respiratory medicine · Aug 2014
Randomized Controlled Trial Multicenter Study Comparative StudyEfficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Fluticasone furoate/vilanterol (FF/VI) is an inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA), recently approved as once-daily maintenance therapy for COPD. We compared the lung function effects of FF/VI with those of twice-daily fluticasone propionate/salmeterol (FP/SAL). ⋯ clinicaltrials.gov: NCT01323634; NCT01323621; NCT01706328. GlaxoSmithKline study codes: HZC113109; HZC112352; RLV116974.
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Respiratory medicine · Aug 2014
Randomized Controlled Trial Multicenter Study Comparative StudyExtrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations.
The FORWARD study is a randomised, double-blind trial that compares the efficacy and safety of 48 weeks treatment with extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI, 2 inhalations BID, vs. FOR 12 μg pMDI, 1 inhalation BID, in severe COPD patients with a history of exacerbations. Co-primary endpoints were exacerbation rate over 48 weeks and pre-dose morning FEV(1) at 12 weeks. ⋯ Pneumonia incidence was low, slightly higher with BDP/FOR (3.8%) than with FOR (1.8%). No difference for laboratory values, ECG or vital signs. Extrafine BDP/FOR significantly reduces the exacerbation rate and improves lung function of patients with severe COPD and history of exacerbations as compared to FOR alone.
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Respiratory medicine · Aug 2014
Randomized Controlled Trial Multicenter StudySystemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent.
Prescription of inhaled corticosteroids to children with asthma is recommended at half the nominal dose of adults in order to reduce the risk of systemic side effects. However, there is a lack of pharmacokinetic trials supporting such dose reduction regimens. Therefore, we aimed to compare the systemic exposure to the active ingredients of a fixed dose combination of beclometasone-dipropionate (BDP) and formoterol after dry powder inhaler (DPI) administration in children, adolescents and adults. ⋯ The systemic exposure to the active ingredients of BDP/formoterol administered as DPI correlates inversely with age and body size suggesting that dry powder dosage regimens should be adjusted for age and body size to avoid high systemic drug levels in children.
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Respiratory medicine · Aug 2014
Randomized Controlled TrialResistance training as a preconditioning strategy for enhancing aerobic exercise training outcomes in COPD.
Aerobic exercise training is a recognized approach for improving functional capacity in COPD. People with greater disease severity often have difficulty achieving higher aerobic exercise training intensity. The effects of resistance training prior to aerobic training were examined to determine if this sequential approach was associated with greater gains in functional status than aerobic training alone or concurrent aerobic and resistance training. ⋯ Although the sequential approach to resistance and aerobic training yielded a greater increase in muscle endurance and higher resistance training volume compared to concurrent resistance and aerobic training, other training outcomes were similar between the two groups, thus the sequential approach is not clearly superior to the concurrent approach in severe COPD. ClinicalTrials.gov Identifier: NCT01058213.