Respiratory medicine
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Respiratory medicine · Feb 2017
Multicenter StudyLung function, percent emphysema, and QT duration: The Multi-Ethnic Study of Atherosclerosis (MESA) lung study.
The QT interval on electrocardiogram (ECG) reflects ventricular repolarization; a prolonged QT interval is associated with increased mortality risk. Prior studies suggest an association between chronic obstructive pulmonary disease (COPD) and prolonged QT interval. However, these studies were small and often enrolled hospital-based samples. We tested the hypotheses that lower lung function and increased percent emphysema on computed tomography (CT) are associated with a prolonged QT interval in a general population sample and additionally in those with COPD. ⋯ Our analysis revealed a significant association between lower lung function and longer QTc in men but not in women in a population-based sample. Our findings suggest the possibility of gender differences in the risk of QTc-associated arrhythmias in a population-based sample.
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Respiratory medicine · Jan 2017
Multicenter StudyRationale and study design of RESPITE: An open-label, phase 3b study of riociguat in patients with pulmonary arterial hypertension who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors.
Patients with pulmonary arterial hypertension (PAH) who do not have an adequate response to therapy with phosphodiesterase-5 inhibitors (PDE-5i) may have insufficient synthesis of cyclic guanosine monophosphate (cGMP). These patients may respond to a direct soluble guanylate cyclase (sGC) stimulator such as riociguat. RESPITE (NCT02007629) was an open-label, multicenter, uncontrolled, single-arm phase 3b study of riociguat in patients with PAH who demonstrated an insufficient response to treatment with PDE-5i. ⋯ The following biomarkers were to be measured: cGMP, asymmetric dimethyl arginine, growth-differentiation factor-15, and ST2. Results from RESPITE will help to determine if PAH patients who do not respond to PDE-5i are likely to benefit from treatment with an sGC stimulator. The study may also identify biomarkers that are able to suggest which patients are more likely to respond to sGC stimulators.
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Respiratory medicine · Dec 2016
Randomized Controlled Trial Multicenter Study Comparative StudyA randomized, controlled multicentric study of inhaled budesonide and intravenous methylprednisolone in the treatment on acute exacerbation of chronic obstructive pulmonary disease.
Almost all international guidelines recommend corticosteroids for management of exacerbations of chronic obstructive pulmonary disease (COPD), because it leads to improved outcomes of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Nevertheless, due to its side effects, there are still concerns regarding the use of systemic corticosteroid (SC). Inhaled corticosteroids (IC) can be used as an alternative to SC, while reducing the risk of occurrence of side effects. ⋯ Results show that inhalation of budesonide (2 mg 3 times/day) and systemic methylprednisolone (40 mg/day) had similar clinical outcome in AECOPD. In conclusion, inhaled budesonide is an alternative to systemic corticosteroids in AECOPD treatment.
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Respiratory medicine · Nov 2016
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD.
This study formed part of the dose selection for a glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination formulated using novel Co-Suspension™ Delivery Technology and delivered via a metered dose inhaler (GFF MDI). The study aimed to confirm the optimal dose of GP to formulate with FF 9.6 μg in the fixed-dose combination product, GFF MDI. ⋯ These findings further support selection of GP 18 μg as the optimal dose to combine with FF MDI 9.6 μg for advancement into Phase III clinical trials of GFF MDI.
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Respiratory medicine · Jun 2016
Randomized Controlled Trial Multicenter StudyLong-term safety of glycopyrrolate: A randomized study in patients with moderate-to-severe COPD (GEM3).
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in the United States. Long-acting muscarinic antagonists (LAMAs) are a class of medications used as maintenance therapy for COPD. The GEM3 (Glycopyrrolate Effect on syMptoms and lung function) study assessed the long-term safety and efficacy of a LAMA, glycopyrrolate (GLY) 15.6 μg twice daily (b.i.d.), compared with an approved long-acting β2-agonist (LABA), indacaterol (IND) 75 μg once daily (q.d.) in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation. ⋯ NCT01697696.