The effect of AZD7624 on LPS challenge

• Research type

  Research Study

• Full title

  A Double blind, Randomised, Placebo-controlled, 2-period, Cross-over Study in Healthy Volunteers to Investigate the Effects of a Single Dose of Inhaled AZD7624 on White Blood Cells and Inflammatory Markers in Induced Sputum and Blood after Oral Inhalation of 45,000 Endotoxin Units Lipopolysaccharide (LPS)

• IRAS ID

  136575

• Contact name

  Saeed Khan

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2013-002756-32

• Research summary

  COPD is a chronic lung disease. People with COPD have trouble breathing in and out, known as airflow obstruction. Their lungs become inflamed due to irritation, usually from cigarette smoke.

  AZD7624 is an anti-inflammatory drug that stops an enzyme called p38 mitogen-activated protein kinase (MAPK) from working. This enzyme plays an important role in the inflammation of lungs in COPD. Information from animal and laboratory tests suggests that AZD7624 might be helpful in the treatment of lung inflammation in COPD.

  The purpose of this study is to find out the effect of AZD7624 on inflammatory response to inhaled lipopolysaccharide (LPS) (LPS is bacterial cell wall fragment) in the lungs of healthy volunteers in comparison with placebo (dummy drug). When a healthy subject inhales a low dose of LPS, the cells inside the lung respond in a manner which is similar to that seen in people with COPD, but this effect is short-lived. This study will look at the effect of each treatment on the inflammation in the lung following LPS challenge. This study will also measure levels of drug in the blood and see how well it is tolerated. The results from this study will support decisions regarding the future development of AZD7624 .

  AZD7624 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.

  Approximately 26 healthy volunteers will be enrolled into the study.

  For each subject the study will usually involve a screening/consent visit, 2 study periods with a gap of at least 28 days in between each period, 2 Baseline visits (one before each study period) and a follow-up visit. The total duration for participation in this study is approximately 10-14 weeks.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0624

• Date of REC Opinion

  2 Oct 2013

• REC opinion

  Further Information Favourable Opinion