Study to Assess the PD of Albuterol MDI HEXAL compared to Proventil®

• Research type

  Research Study

• Full title

  A Multi-centre, Single Dose, Randomised, Five-Period Cross-Over, Double-Blind, Double-Dummy, Placebo-controlled Study to Assess the Pharmacodynamic Equivalence of Albuterol MDI HEXAL (TEST) Compared to Proventil® HFA Inhalation Aerosol (REFERENCE), Schering-Plough, US, in Asthmatic Patients

• IRAS ID

  123314

• Contact name

  Leonard Siew

• Sponsor organisation

  HEXAL AG

• Eudract number

  2012-003978-56

• Research summary

  This study is being carried out in patients with mild to moderate asthma.Two products are being investigated in this study. One product Proventil© hydfluroalkane (HFA) inhalation aerosol inhaler is a licensed medication for the treatment of asthma, which is available in the United States of America. The other product Albuterol metered dose inhaler is being developed by the Sponsor Hexal AG. It contains the same active ingredient, Albuterol Sulphate, as Proventil© hydfluroalkane (HFA) inhalation aerosol (the reference product); however the inhalation device is different from the Proventil© hydfluroalkane (HFA) inhalation aerosol.Albuterol Sulphate is widely used to treat lung disorders involving bronchospasm (breathing distress caused by narrowing of the airways). It is used in treating conditions such as asthma (a lung disease associated with tightening of the air passages) and chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small air sacs of the lungs become damaged. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. Its principal effect is bronchodilatation (opening up of the airways) by relaxation of the muscles.The purpose of this study is to investigate the pharmacodynamics (effect of the drug on the body), safety and tolerability of test product Albuterol metered dose inhaler by comparing it with the reference product Proventil© hydfluroalkane (HFA) inhalation aerosol inhaler.This research will involve administration of a single dose in five periods. Patients will receive all five treatments. Hexal AG is sponsoring this study. Approximately 110 patients in 4 study centres in 3 countries will participate in this study.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  13/LO/0008

• Date of REC Opinion

  19 Mar 2013

• REC opinion

  Further Information Favourable Opinion