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OpenTrials
Completed

NCT Number: NCT01076322

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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.
  • Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;

Exclusion criteria

  • Hypersensitivity to β2-agonist or lactose;
  • Hospitalization due to asthma during the previous 3months;
  • Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
  • Oral or systemic corticosteroids in the previous 4weeks;
  • Inadequately controlled hyperthyroidism;
  • Severe hepatic or renal or cardiovascular disease as judged by the investigator;
  • Patients receive an investigational drug within 30 days prior to admission to the study;
  • Patients with significant alcohol, drug or medication abuse as judged by the investigator;
  • 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).

Treatment and study plan

Meptin® Swinghaler

Drug

Meptin® Swinghaler®

  • Ingredient: Procaterol HCL
  • Dosage form: 10g/puff
  • Dose(s): 10g
  • Dosing schedule: 20g (total 20g)

Other names: Meptin® Swinghaler®, Procaterol HCL, Ventolin® MDI, Salbutamol sulfate

Ventolin® MDI

Drug

Ventolin® MDI

  • Ingredient: Salbutamol sulfate
  • Dosage form: 100g/puff
  • Dose(s): 100g
  • Dosing schedule: 200g (total 200g)

Primary outcomes

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

    Time frame: 2 days

Secondary outcomes

  1. The change in sGaw

    Time frame: 2 days

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

    Time frame: 2 days

  3. The change in Peak Expiratory Flow Rate (PEFR)

    Time frame: 2 days

  4. The change in Forced Vital Capacity (FVC)

    Time frame: 2 days

  5. The change in Oxygen Saturation (SpO2)

    Time frame: 2 days

  6. The change in Borg scale

    Time frame: 2 days

  7. Device acceptance

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Taiwan Otsuka Pharm. Co., Ltd

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 26, 2010
Registry last updated
Aug 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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