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

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076322
• Other study ID #: 002-TWB-0801
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2010
• Last updated: August 10, 2010
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2010
• Source: Taiwan Otsuka Pharm. Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 ß2-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 ß2-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Meptin® Swinghaler
Meptin® Swinghaler® Ingredient: Procaterol HCL Dosage form: 10g/puff Dose(s): 10g Dosing schedule: 20g (total 20g)
• Ventolin® MDI
Ventolin® MDI Ingredient: Salbutamol sulfate Dosage form: 100g/puff Dose(s): 100g Dosing schedule: 200g (total 200g)

Locations

Country	Name	City	State
Taiwan	Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Otsuka Pharm. Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Forced Expiratory Volume in 1 second (FEV1) value.		2 days	No
Secondary	The change in sGaw		2 days	No
Secondary	The changes in IOS parameters (R, X and RF)		2 days	No
Secondary	The change in Peak Expiratory Flow Rate (PEFR)		2 days	No
Secondary	The change in Forced Vital Capacity (FVC)		2 days	No
Secondary	The change in Oxygen Saturation (SpO2)		2 days	No
Secondary	The change in Borg scale		2 days	No
Secondary	Device acceptance		2 days	No