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

Information source: Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Meptin® Swinghaler (Drug); Ventolin® MDI (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Taiwan Otsuka Pharm. Co., Ltd

Official(s) and/or principal investigator(s):
Ping-Hung Kuo, MD, Principal Investigator, Affiliation: National Taiwan University Hospital

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.

Clinical Details

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

Primary outcome: The change in Forced Expiratory Volume in 1 second (FEV1) value.

Secondary outcome:

The change in sGaw

The changes in IOS parameters (R, X and RF)

The change in Peak Expiratory Flow Rate (PEFR)

The change in Forced Vital Capacity (FVC)

The change in Oxygen Saturation (SpO2)

The change in Borg scale

Device acceptance

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Taiwan University Hospital, Taipei, Taiwan
Additional Information

Starting date: March 2009
Last updated: August 10, 2010

Page last updated: August 23, 2015

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