A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Meptin® Swinghaler; Drug: Ventolin® MDI

• Registration Number: NCT01076322
• Lead Sponsor: Taiwan Otsuka Pharm. Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-08-10
• Last Update Posted: 2010-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment-A sequence	Ventolin® MDI	Meptin® Swinghaler / Ventolin® MDI
Treatment-B sequence	Ventolin® MDI	Ventolin® MDI / Meptin® Swinghaler
Treatment-B sequence	Meptin® Swinghaler	Ventolin® MDI / Meptin® Swinghaler
Treatment-A sequence	Meptin® Swinghaler	Meptin® Swinghaler / Ventolin® MDI

Primary Outcome Measures

Name	Time	Method
The change in Forced Expiratory Volume in 1 second (FEV1) value.	2 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Taiwan University Hospital; 🇨🇳 Taipei, Taiwan