Systemic therapeutic protein delivery through the lungs could potentially replace delivery by injection, but safety needs to be established in patients with known pulmonary disease. This study determined the short-term safety profile of recombinant human growth hormone (rhGH; somatropin) inhalation therapy in clinically stable adult subjects with mild to moderate asthma and methacholine sensitivity. This randomized, placebo-controlled study had two phases: (1) an escalating 3-dose, 4-day/dosage tolerance phase; and (2) a 14-day, crossover design comparability phase.
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