Bronchial asthma
Conditions
Interventions
Observation period: combined therapy with fluticasone and salmeterol (Adair Discus) for 2-4 weeks Treatment period: combined therapy with fluticasone and formoterol (Flutiform) for 8 weeks
Sponsors
Teikyo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: <Observation period> Those who fulfill the following criteria at Visit 1 are eligible: 1) Outpatients aged 60 years or more at informed consent 2) Patients with asthma that is insufficiently or poorly controlled according to JGL2012 3) Patients with asthma that can be treated according to its severity 4) Those who have been treated with a constant dose of Adair Discus for at least 4 weeks 5) Those who can provide informed consent in writing <Treatment period> Those who fulfill the following criteria at Visit 2 are eligible: 1) Those who did not develop respiratory tract infection or upper respiratory tract inflammation during the observation period 2) Those in whom asthma was not aggravated by urgent treatment or drugs for long-term control during the observation period. For aggravated asthma, systemic steroids, aminophylline infusion, and on-demand SABA can be used. 3) Those in whom the severity of asthma according to JGL2012 remains the same as at Visit 1. 4) Those in whom asthma was treated with a constant dose of Adair Discus during the observation period. 5) Those who the investigator or sub-investigator judges are eligible
Exclusion criteria
Exclusion criteria: Those who meet any of the following criteria below at Visit 1 are ineligible: 1) Previous diseases/complications: - Those in whom respiratory tract infection or upper respiratory tract inflammation is seen. Those who the investigator judges are eligible are to be included even if any of the following complications is seen: infections other than respiratory tract infection, hyperthyroidism, hypertension, heart diseases, diabetes, and hypercalcemia. - Those who the investigator judges are ineligible due to serious heart/liver/kidney/lung/blood diseases or other serious complications - Those who have or have had malignant tumors in the past 5 years - Those who have antibiotic-resistant infections or deep mycosis - Those who had an aggravation of asthma requiring hospitalization, urgent treatment, or changes in drugs for long-term control within 4 weeks of enrollment 2) Medications/therapies - Those who developed moderate or worse adverse drug reactions requiring medications or other treatments when treated with ICS or/and LABA - Those who are taking SABA regularly or for preventive purposes, including those who are taking drugs for asthma attack improperly (using unapproved dosage/administration) 3) Others - Those who cannot properly use inhalants - Those who cannot properly undergo a respiratory function test - Those who the investigator or sub-investigator judges are ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 | — |
Countries
Japan
Contacts
Public ContactNobuhide Mori
Mebix, Inc. Research Promotion Head Office
Outcome results
None listed