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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Ventolin® MDI; Drug: Meptin® Swinghaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01076322

002-TWB-0801

Details and patient eligibility

About

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.

Enrollment: 17 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Treatment-A sequence

Experimental group

Description:

Meptin® Swinghaler / Ventolin® MDI

Treatment:

Drug: Meptin® Swinghaler

Drug: Ventolin® MDI

Treatment-B sequence

Experimental group

Description:

Ventolin® MDI / Meptin® Swinghaler

Treatment:

Drug: Meptin® Swinghaler

Drug: Ventolin® MDI