Asthma
Conditions
Brief summary
This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable asthma patients
Interventions
DRUGMeptin swinghaler
* Dose: 10ug/puff, 2 puffs daily * Frequency: QD (total 20ug/day) * Treatment duration: 2 days
DRUGBerotec
* Dose: 100ug/puff, 2 puffs daily * Frequency: QD (total 200ug/day) * Treatment duration: 2 days
Sponsors
Taiwan Otsuka Pharm. Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or females outpatients aged ≥18 years old with uncontrolled or partly controlled asthma; Stability was assessed during the past 14 days the patients remained in the same severity class by 2006 GINA guideline (uncontrolled, partly controlled) and had no acute exacerbations by investigator judgment; * Pulmonary function test: Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ; Positive result of Brocho-provocation test;
Exclusion criteria
* Hypersensitivity to β2-agonist or lactose; * Hospitalization due to asthma during the previous 3 months; * Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks; * Oral or systemic corticosteroids in the previous 4 weeks; * Inadequately controlled hyperthyroidism; * Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system or respiratory disease other than asthma(e.g. COPD), or any other disorder which may interfere wth the study evaluations or affect subject safety; * Patients receive an investigational drug within 30 days prior to admission to the study; * Patients with significant alcohol, drug or medication abuse as judged by the investigator; * Females who are pregnant or breast-feeding; (exception: Females of child-bearing age might be included, if in the opinion of the investigator, they are using adequate contraceptive precautions); * Subjects who are heavy smoker (more than 10 packs year) or who are smoking within previous 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of Forced Expiratory Volume in 1 second (FEV1) value | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Peak Expiratory Flow Rate (PEFR) | 12 months | — |
| The change of Forced Vital Capacity (FVC) | 12 months | — |
| Device acceptance | 12 months | 5-point score of evaluation form to test preference on Meptin swinghaler/ Berotec device by investigator or patient |
Countries
Taiwan
Outcome results
None listed