A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy - A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy

Kinki Respiratory and Allergy Diseases Research Group0 个研究点目标入组 100 人开始时间: 2012年10月1日最近更新: 2023年10月17日

适应症

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•* Patients with a history of hypersensitivity to components of budesonide/formoterol combination (including contact dermatitis) * Patients with an infectious disease or deep mycosis, both of which cannot be treated effectively by any antimicrobial drug * Patients with tuberculosis * Patients with a history of usage of long-acting beta agonist or some drug containing a long-acting beta agonist within 4 weeks before enrollment * Patients with a respiratory infectious disease that affects asthma; onset of the infection should have occurred within 4 weeks before enrollment * Patients receiving beta-blocker, including an eye drop * Patients who are administered a systemic steroid within 30 days before enrollment * Patients with a clinically serious comorbidity * Patients with FEV1 values less than 60% of the predicted value * Smokers or patients with a smoking history of more than 10 pack-years, or a former smoker who stopped smoking in the 6 months before enrollment * Patients who are planning to become pregnant, or who are pregnant, or are breast-feeding * Those who cannot provide a written informed consent by themselves * Those concluded to be ineligible by the investigator

发起方

Kinki Respiratory and Allergy Diseases Research Group