A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Phase 2 Completed 230 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

Timeline

Start: 2008-02
Primary completion: 2009-12
Completion: 2009-12

Outcome

Met primary endpoint

paper PH-797804 showed a statistically significant improvement in trough FEV1 at week 6 compared with placebo of 0.086 litre (95% Bayesian CI 0.008 to 0.164) PMID 23539534 ↗

Publications

MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PH-797804	Small molecule	0.5 mg	Oral
Subject	PH-797804	Small molecule	3 mg	Oral
Subject	PH-797804	Small molecule	6 mg	Oral
Subject	PH-797804	Small molecule	10 mg	Oral