A study to confirm equivalence between Z7200 and Symbicort in asthma

• Research type

  Research Study

• Full title

  A single dose, randomized, double-blind, double-dummy, placebo-controlled, 5-period cross-over study to confirm the therapeutic equivalence between Z7200 and Symbicort® Turbohaler® at two different dose levels in adults and adolescents with stable persistent asthma

• IRAS ID

  190343

• Contact name

  Luca Raiteri

• Contact email

  luca.raiteri@zambongroup.com

• Sponsor organisation

  Zambon SpA

• Eudract number

  2015-003232-13

• Duration of Study in the UK

  0 years, 4 months, 1 days

• Research summary

  The study drug called Z7200 is a potential new inhaled medicine that is being developed for the treatment of two lung diseases (asthma and chronic obstructive pulmonary disease (COPD)).

  Z7200 is a combination of two different drugs;
  • Budesonide – is an ‘inhaled corticosteroid (ICS)’, which works by reducing inflammation and mucus production in the airways making it easier to breathe
  • Formoterol Fumarate – is a ‘long-acting beta agonist (LABA)’, which works by causing bronchodilation (opens up the airways)

  The main purpose of this study is to determine if the Formoterol Fumarate component of Z7200 is as effective as the Formoterol Fumarate component in Symbicort® Turbohaler®, which is a licenced drug (can be prescribed by GPs) for asthma and COPD and contains the same active ingredients as Z7200. Symbicort® Turbohaler® is well established and has been available and marketed worldwide for more than 10 years.
  
  Z7200 is manufactured using a new technology called Edry™. The benefit of which is that, in theory, a greater proportion of the inhaled dose reaches deep into the lungs, so that the same medicinal effect can be achieved with a smaller total inhaled dose.

  Placebos (‘dummy drugs’ containing no active ingredients) will also be administered, which are used to fairly compare the different treatments.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  15/NW/0918

• Date of REC Opinion

  12 Apr 2016

• REC opinion

  Further Information Favourable Opinion