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
- Conditions
- bronchial asthma
- Registration Number
- JPRN-UMIN000008912
- Lead Sponsor
- Kinki Respiratory and Allergy Diseases Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of the number of days on which asthma is well controlled in the patients during the entire treatment period
- Secondary Outcome Measures
Name Time Method (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