Study of lung bioavailability of AZD5423 given by 4 inhalation devices

• Research type

  Research Study

• Full title

  A Phase I, Single-Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler®, SPIRA nebulizer and I-neb® AAD System

• IRAS ID

  109064

• Contact name

  Arpeat Kaviya

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2012-002307-17

• Research summary

  AZD5423 is a new drug being developed as a possible once daily treatment for patients with chronic obstructive pulmonary disease (COPD) and asthma. Currently available treatments for these conditions include medications that relax and widen the airway tubes in the lung (e.g. salbutamol inhaler) or reduce the amount of inflammation in the lung (e.g. steroid inhaler such as budesonide). In mild disease these medications work well in controlling symptoms. However, in moderate and severe disease the use of steroids can lead to side effects that limit the dose that can be given. The rationale for developing AZD5423 is the unmet need for a more effective treatment of COPD. AZD5423 is expected to work in the body in an identical way to steroids but with a potential for decreased risk of side effects at doses relevant to patients. It is expected to be more selective for its target (site of action in the cells in the body) so is less likely to cause problems elsewhere in the body. It will also hopefully improve convenience by being of use once a day compared to twice daily as is the case for current steroid inhalers. Until now, the development of AZD5423 in early clinical studies has involved giving the drug to people by inhalation (breathing in through the mouth) using a variety of devices including Turbuhaler©, I-neb and SPIRA devices. The purpose of this research study is to study a new dry powder inhaler which is under development and assess how much of the drug when inhaled through the mouth actually reaches the lungs compared to the other three devices.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0958

• Date of REC Opinion

  27 Jul 2012

• REC opinion

  Further Information Favourable Opinion