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ASTHMA

  • Comparison of a beta 2-agonist, terbutaline, with an inhaled corticosteroid, budesonide, in newly detected asthma. New Engl J Med 1991; 325:388–92.

    • - Randomized, blinded trial comparing terbutaline and budesonide, which provided early evidence useful for establishing inhaled corticosteroids as a first-line treatment in asthma management.

  • The Salmeterol Multicenter Asthma Research Trial (SMART). Chest 2006;129(1):15–26.

    • - Randomized, double-blinded, placebo-controlled trial of salmeterol BID for asthma in patients >12 yr old. Demonstrated a small but statistically significant increase in respiratory- and asthma-related deaths for the population receiving salmeterol, particularly for African Americans who were enrolled in the trial.

  • As-needed budesonide-formoterol versus maintenance budesonide in mild asthma. N Engl J Med 2018;378(20):1877–1887.

    • - Randomized, double-blinded, placebo-controlled trial that demonstrated budesonide–formoterol PRN was noninferior to budesonide BID with respect to the rate of severe asthma exacerbations and resulted in approximately one-quarter of the inhaled glucocorticoid exposure. However, symptom control was inferior in the budesonide–formoterol PRN group.

COPD

  • Antibiotic therapy in exacerbations of COPD. Ann Intern Med 1987;106:196–204.

    • - Randomized, double-blinded, placebo-controlled study assessing antibiotic use when all three cardinal symptoms of an acute exacerbation of COPD were present (i.e., increased dyspnea, increased sputum production, increased sputum purulence). Results demonstrated less failure with use of antibiotics; however, this improvement was not significant after controlling for use of oral steroids.

  • Antibiotics in addition to systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2010;181:150–157.

    • - Randomized, placebo-controlled study to evaluate the effect of adding doxycycline to prednisone for patients presenting with dyspnea and increased sputum volume; patients with fever or chest radiograph consistent with pneumonia were excluded. The results demonstrated no significant improvement in 30-day clinical response with antibiotics, although clinical cure/clinical success at day 10 were improved in the antibiotic arm.

INSTERSTITIAL LUNG DISEASE

  • A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med 2014;370:2083–2092.

    • - Randomized, placebo-controlled trial which demonstrated that pirfenidone slowed the rate of decline in FVC for patients with IPF (no decline in FVC for 23% patients treated with pirfenidone vs. 9.7% patients treated with placebo; >10% decline in FVC for 17% patients treated with pirfenidone vs. 32% patients treated with placebo).

  • Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med 2014;370:2071–2082.

    • - Randomized, placebo-controlled trial which demonstrated that nintedanib slowed the rate of decline in FVC for patients with IVF (115 mL decrease in FVC in patients treated with pirfenidone vs. 240 mL decrease in FVC in patients treated with placebo over 1 yr).

CYSTIC FIBROSIS

  • A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med 2011;365:1663–1672.

    • - Seminal study that demonstrated a considerable benefit from a therapy that targeted cystic fibrosis’s underlying genetic cause. In this study, patients with at least one ...

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