Asthma

This study is not active

Asthma (AZ-ma) is a lung disease that inflames and narrows the airways. Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath, and coughing. The coughing often occurs at night or early in the morning.​

​We are seeking approval for a new inhaler formulation. The study medication will be compared to an FDA approved inhaler formulation, Qvar.

The purpose of this study is to demonstrate the non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function in asthmatic patients, as well as the effect of the test treatments in terms of additional lung function parameters and clinical outcome measures. The purpose is also to assess the safety and tolerability.treatment in terms of additional lung function parameters and clinical outcome measures, and assessement of the safety and tolerability [ Time Frame: Baseline to week 12 ]

Eligibility Criteria

  • Male or female outpatients, Chinese ethnicity aged >18 years with a clinical diagnosis of asthma for a minimum of 6 months prior to visit 1 confirmed by a chest physician according to International guidelines updated 2016 Global Initiative Asthma (GINA).
  • Positive Response to Reversibility Test.
  • FEV 1 (Forced Expiratory Volume within the first second) >80% of the predicted normal value after appropriate washout from bronchodilators.
  • Patients on previous regular treatment at a stable dose for at least 3 months prior to visit 1 with either high daily dose of ICS ( Inhaled Corticosteroids) or medium daily dose of ICS

The study is 3 months long and there will be 5 office visits at our site.

The trial doctor will review other eligibility criteria with you. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453112

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