Respiratory medicine
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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 · Jul 2014
Randomized Controlled Trial Multicenter Study Comparative StudyAmbulatory adaptation to noninvasive ventilation in restrictive pulmonary disease: a randomized trial with cost assessment.
Home mechanical ventilation is usually initiated in hospital. However, cost-effectiveness of inpatient set up has never been compared to outpatient adaptation in a randomized design. A Prospective, multicenter, non-inferiority trial was conducted comparing the effectiveness of adaptation to noninvasive mechanical ventilation (NIMV) performed in the ambulatory or hospital setting in patients with chronic respiratory failure secondary to restrictive thoracic disease, obesity-hypoventilation syndrome or neuromuscular disease. ⋯ Identifier number NCT00698958 at www.clinicaltrials.gov.
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Respiratory medicine · May 2014
Multicenter StudyDeterminants of exercise capacity in obese and non-obese COPD patients.
The effects of obesity in combination with chronic obstructive pulmonary disease (COPD) on exercise capacity are receiving increased attention. But, a comprehensive analysis of factors associated with aerobic capacity in obese COPD patients has not been performed. ⋯ Obese and non-obese COPD patients show different determinants of aerobic capacity, including pulmonary and non-pulmonary factors that are also dependent on the type of exercise protocol. These results could be considered in the evaluation of obese patients with COPD.