Study of lung bioavailability of AZD8683 given by 2 inhalation devices

• Research type

  Research Study

• Full title

  A Phase I, Single-centre, Open, Partly Randomised, Cross-over Single Dose Study in Healthy Volunteers to Evaluate the AZD8683 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler and via Turbuhaler™

• IRAS ID

  110782

• Contact name

  Arpeat Kaviya

• Contact email

  arpeat.kaviya@quintiles.com

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2012-002901-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) refers to chronic bronchitis and emphysema, a disease of the lungs in which the airways become inflamed and the small air sacs of the lungs become damaged. This leads to a reduced air flow to and from the lungs causing shortness of breath, cough and increased sputum production. The major cause of COPD is long term cigarette smoking.

  AZD8683 is a new medication being developed as a possible treatment for patients with COPD. The rationale for developing AZD8683 is the unmet need for more effective treatment of COPD symptoms, particularly breathlessness. The advantage of AZD8683 is its long duration of effect, allowing once-daily treatment, resulting in convenience for the patient.
  
  AZD8683 is a type of treatment called a muscarinic antagonist. These work by relaxing the muscles that surround the small and large airways in the lung, widening the airways making it easier to breathe

  AZD8683 is given using an inhaler device. An inhaler, also known as a puffer, is a device which delivers drug to the lungs by the patient breathing the drug in. So far, AZD8683 has been given to volunteers using a Turbuhaler™ device in early clinical studies. A new Dry Powder Inhaler (DPI) device is now under development and is intended to be used in upcoming studies. It is hoped that this new inhaler will provide a more convenient way to deliver the AZD8683 drug to the lungs. The purpose of this study is to assess how much of the drug AZD8683 reaches the lungs when breathed in using the new DPI inhaler and also the Turbuhaler by measuring blood levels of the drug after dosing and comparing these values with those achieved when the drug is given orally and also intravenously.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/1310

• Date of REC Opinion

  5 Oct 2012

• REC opinion

  Further Information Favourable Opinion