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ICS Hazard Ratio (95 CI)b Serious asthma-related eventc.10 (0.85,.44) Asthma-related death 2 0 Asthma-related intubation (endotracheal) 1 2 Asthma-related hospitalization (24-hour stay) 115 105 ICS Inhaled Corticosteroid, laba Long-acting Beta2-adrenergic Agonist. No dosage adjustment is required in patients with renal impairment see Clinical Pharmacology (12.3). Patients were symptomatic with a history of moderate or severe exacerbations within the previous year. Deterioration of Disease and Acute Episodes Breo Ellipta should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of copd or asthma. In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension. At screening in the treatment group using Breo Ellipta 100/25, the mean postbronchodilator percent predicted FEV1 was 48 (range: 18 to 70 the mean (SD) FEV1/ FVC ratio was.52 (0.10 and the mean percent reversibility was 12 (range: -26 to 84). tremor nervousness bone thinning or weakness (osteoporosis).

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