bronchial asthma
Conditions
Interventions
Step-down therapy group: Initially, budesonide/formoterol combination will be administered at the dosage of 2 inhalations twice a day (bid) for 12 weeks. If asthma is well controlled, the dosage wil
Sponsors
Kinki Respiratory and Allergy Diseases Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Male and female outpatients, who are aged at least 20 years * Treatment with inhaled corticosteroid at a dosage equivalent to 400 to 800 mcg/day or a lower dose of budesonide for at least 4 weeks, immediately before the patients are enrolled * Patients with poorly controlled asthma * Those who can provide written consent
Exclusion criteria
Exclusion criteria: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of the number of days on which asthma is well controlled in the patients during the entire treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The outcomes after 12 and 24 weeks of treatment are as follows: * Change in the results of respiratory function tests from the ones obtained before treatment * Change in exhaled nitric oxide level from that before treatment * Change in respiratory resistance from the pretreatment observation (2) The parameters analyzed during the entire treatment period are as follows: * Asthma symptom scores for daytime and nighttime * Asthma Control Questionnaire score * Frequency of use of relievers in daytime and nighttime * Total number of weeks in which well-controlled asthma status is achieved * Episodes of nocturnal awaking due to asthma symptoms * Adherence to study drug consumption in the morning and evening (3) Adverse event | — |
Countries
Japan
Contacts
Public ContactTakashi Iwanaga
Kinki University, Faculty of Medicine Department of Respiratory Medicine and Allergology
Outcome results
None listed