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 Ventolin® MDI in stable asthma patients.
Interventions
DRUGMeptin® Swinghaler
Meptin® Swinghaler® * Ingredient: Procaterol HCL * Dosage form: 10g/puff * Dose(s): 10g * Dosing schedule: 20g (total 20g)
DRUGVentolin® MDI
Ventolin® MDI * Ingredient: Salbutamol sulfate * Dosage form: 100g/puff * Dose(s): 100g * Dosing schedule: 200g (total 200g)
Sponsors
Taiwan Otsuka Pharm. Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or females outpatients aged ≥ 16 years old with stable mild to moderate persistent asthma; Stability was assessed the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days; 2. Pulmonary function test: * Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ; * Positive result of Broncho-provocation test (PC20 ≤ 32 mg/ml) before the study. 3. Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;
Exclusion criteria
1. Hypersensitivity to β2-agonist or lactose; 2. Hospitalization due to asthma during the previous 3months; 3. Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks; 4. Oral or systemic corticosteroids in the previous 4weeks; 5. Inadequately controlled hyperthyroidism; 6. Severe hepatic or renal or cardiovascular disease as judged by the investigator; 7. Patients receive an investigational drug within 30 days prior to admission to the study; 8. Patients with significant alcohol, drug or medication abuse as judged by the investigator; 9. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Forced Expiratory Volume in 1 second (FEV1) value. | 2 days |
Secondary
| Measure | Time frame |
|---|---|
| The changes in IOS parameters (R, X and RF) | 2 days |
| The change in Peak Expiratory Flow Rate (PEFR) | 2 days |
| The change in Forced Vital Capacity (FVC) | 2 days |
| The change in sGaw | 2 days |
| The change in Borg scale | 2 days |
| Device acceptance | 2 days |
| The change in Oxygen Saturation (SpO2) | 2 days |
Countries
Taiwan
Outcome results
None listed