To investigate the effects of Multiple Ascending Doses of AZD8683

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Double-Blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD8683 in Healthy Volunteers and of Repeated Inhalation of One Dose Level of AZD8683 in Patients with Chronic Obstructive Pulmonary Disease (COPD), given Once Daily via Turbuhaler

• IRAS ID

  97988

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-005588-25

• Research summary

  AZD8683 is a new medication, being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). This is not the first time this drug has been given to human volunteers. 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. The rationale for developing AZD8683 is the unmet need for more effective treatment of COPD symptoms, particularly breathlessness. The foreseen advantage of AZD8683 is its long duration of effect, allowing once-daily treatment, resulting in convenience for the patient. The purpose of this research study is to evaluate safety and tolerability of AZD8683 and how much AZD8683 enters the blood circulation and how much of the drug is cleared from the body by collecting blood and urine samples from volunteers and patients during this study. We are also investigating what AZD8683 is broken down into, when given by inhalation as a single dose and once daily for 12 days (Multiple Ascending Dose) in healthy volunteers. In addition, AZD8683 will be given by inhalation at the same dose level once daily for 12 consecutive days in patients with COPD in order to get an early indication of these aspects in the target patient population. Two optional parts of this study involves the collection of a blood sample from volunteers and patients for biological and genetic (DNA) research. AZD8683 is being developed by AstraZeneca (the Sponsor, a pharmaceutical company) and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy's Hospital (hereafter referred to as Quintiles).

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0431

• Date of REC Opinion

  15 May 2012

• REC opinion

  Further Information Favourable Opinion