NCT01076322CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients
Taiwan Otsuka Pharm. Co., Ltd1 site in 1 country17 target enrollmentStarted: March 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- The change in Forced Expiratory Volume in 1 second (FEV1) value.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •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.
- •Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;
Exclusion Criteria
- •Hypersensitivity to β2-agonist or lactose;
- •Hospitalization due to asthma during the previous 3months;
- •Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- •Oral or systemic corticosteroids in the previous 4weeks;
- •Inadequately controlled hyperthyroidism;
- •Severe hepatic or renal or cardiovascular disease as judged by the investigator;
- •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).
Arms & Interventions
Treatment-A sequence
Experimental
Meptin® Swinghaler / Ventolin® MDI
Intervention: Meptin® Swinghaler (Drug)
Treatment-A sequence
Experimental
Meptin® Swinghaler / Ventolin® MDI
Intervention: Ventolin® MDI (Drug)
Treatment-B sequence
Experimental
Ventolin® MDI / Meptin® Swinghaler
Intervention: Meptin® Swinghaler (Drug)
Treatment-B sequence
Experimental
Ventolin® MDI / Meptin® Swinghaler
Intervention: Ventolin® MDI (Drug)
Outcomes
Primary Outcomes
The change in Forced Expiratory Volume in 1 second (FEV1) value.
Time Frame: 2 days
Secondary Outcomes
- The change in sGaw(2 days)
- 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 Oxygen Saturation (SpO2)(2 days)
- The change in Borg scale(2 days)
- Device acceptance(2 days)
Investigators
Study Sites (1)
Loading locations...
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