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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Meptin® Swinghaler; Drug: Ventolin® MDI

• Study Type: Interventional
• Enrollment (Anticipated): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment-A sequence; Meptin® Swinghaler / Ventolin® MDI	Drug: Meptin® Swinghaler; Meptin® Swinghaler®; Ingredient: Procaterol HCL; Dosage form: 10g/puff; Dose(s): 10g; Dosing schedule: 20g (total 20g); Other Names: Salbutamol sulfate; Meptin® Swinghaler®; Procaterol HCL; Ventolin® MDI; Drug: Ventolin® MDI; Ventolin® MDI; Ingredient: Salbutamol sulfate; Dosage form: 100g/puff; Dose(s): 100g; Dosing schedule: 200g (total 200g)
EXPERIMENTAL: Treatment-B sequence; Ventolin® MDI / Meptin® Swinghaler	Drug: Meptin® Swinghaler; Meptin® Swinghaler®; Ingredient: Procaterol HCL; Dosage form: 10g/puff; Dose(s): 10g; Dosing schedule: 20g (total 20g); Other Names: Salbutamol sulfate; Meptin® Swinghaler®; Procaterol HCL; Ventolin® MDI; Drug: Ventolin® MDI; Ventolin® MDI; Ingredient: Salbutamol sulfate; Dosage form: 100g/puff; Dose(s): 100g; Dosing schedule: 200g (total 200g)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in Forced Expiratory Volume in 1 second (FEV1) value.	2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Taiwan Otsuka Pharm. Co., Ltd

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (ESTIMATE): February 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 12, 2010
• Last Update Submitted That Met QC Criteria: August 10, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Albuterol; Procaterol
• Other Study ID Numbers: 002-TWB-0801