The effects of p38 MAP kinase inhibition on LPS challenge model

• Research type

  Research Study

• Full title

  A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED, 3-WAY CROSSOVER STUDY TO DETERMINE THE EFFECTS OF A SINGLE INHALED DOSES OF PF-03715455 (20 MG) AND PH-797804 (30 MG) ON INDUCED SPUTUM NEUTROPHILS FOLLOWING INHALED LIPOPOLYSACCHARIDE (LPS) CHALLENGE IN HEALTHY VOLUNTEERS.

• IRAS ID

  63495

• Contact name

  Leonard Siew

• Sponsor organisation

  Pfizer Ltd

• Eudract number

  2010-021294-37

• ISRCTN Number

  xx

• Research summary

  COPD (chronic obstructive pulmonary disease) refers to chronic bronchitis and emphysema, a pair of commonly co-existing lung diseases in which the airways become inflamed and the small air sacs of the lungs become damaged. The disease is predominantly caused by long term smoking. Air flow to and from the lungs is reduced causing shortness of breath and unlike asthma, the reduction in airflow in COPD is poorly reversible and gets progressively worse with time.PF-03715455 and PH-797804 are investigational drugs being developed by Pfizer (the Sponsor, a pharmaceutical company) for the treatment of COPD. This study is being carried out on behalf of Pfizer by Quintiles Drug Research Unit at Guy's Hospital and Medicines Evaluation Unit Ltd.The purpose of this study is to investigate the effect of PF-03715455 and PH-797804 on the inflammatory response of the lung, compared to that of placebo following inhalation of lipopolysaccharide (LPS). LPS is bacterial cell wall fragment which when inhaled, causes the lungs to respond in a manner which is similar to that seen in people with COPD, however, unlike in COPD, the effect of LPS on the lungs is short-lived. Up to 18 healthy volunteers are expected to complete the study at, at least 2 clinical pharmacology units in the UK. For each subject the study will involve a screening/consent visit, 3 study periods with a gap of 21 to 28 days in between each period, 2 Baseline visits (one between each study periods) and a follow-up visit. Each study period will require subjects to be admitted to the Research Unit for two days. The total duration for participation in this study is approximately 10-12 weeks.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/75

• Date of REC Opinion

  22 Dec 2010

• REC opinion

  Further Information Favourable Opinion