Patients with moderate to severe asthma with/without turbuhaler-incorporated tracker to assist asthma control
Conditions
Interventions
Budesonide/Formoterol tubuhaler with Dubaobao tracker (160/4.5 mcg per puff, 1 to 2 puffs twice daily plus as needed for 24 weeks)
Budesonide/Formoterol tubuhaler without Dubaobao tracker (160/4.5 mcg
Sponsors
Taipei Veterans General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are considered eligible to enroll if they meet all of the following criteria: 1. Aged from 20 to 80 years. 2. Documented asthma history greater than 6 months before enrollment. 3. Patients who are in need of GINA step 3 to step 5 treatment at enrollment (on low to high dose inhale d corticosteroid/long-acting beta2 agonist with or without concurrent use of other asthma controllers, e.g. tiotropium, leukotriene receptor antagonist [LTRA] etc.). 4. Use of BUD/FOR for at least 4 weeks before enrollment.
Exclusion criteria
Exclusion criteria: Patients who meet any one of the following criteria will be excluded: 1. Hypersensitivity to BUD/FOR. 2. Had lower respiratory tract infections or received systemic steroid 4 weeks before enrollment. 3. Smoking history greater than 20 pack-years. 4. The onset of respiratory symptoms after the age of 40 years in current or previous smokers with a smoking history greater than 10 pack-years. 5. COPD, clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. 6. A chest X-ray indicating diagnosis other than asthma that might interfere with the study. 7. Alcohol or medication abuse. 8. Pregnant woman. 9. Unable or unwilling to sign permit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment difference (post- minus pre-treatment) of FeNO between the tracker and usual care groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Any one of the following conditions are estimated and regarded as secondary objectives: Changes from baseline on ACT score, FeNO, lung function, blood parameters within the same group; Treatment difference (post- minus pre-treatment) on ACT, lung function, blood parameters between the 2 groups; Electronic record of numbers and patterns of inhaler use; Correlation between inhaler use and asthma outcomes (symptoms worsening, any exacerbation, severe exacerbation); Annualized rate of severe exacerbations | — |
Countries
Asia(except Japan)
Contacts
Public ContactKang-Cheng Su
Taipei Veterans General Hospital Department of Chest Medicine
Outcome results
None listed