Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

Summary

Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.

Timeline

Start

2007-01

Primary completion

2008-07

Completion

2008-07

Outcome

Missed primary endpoint

registry analysis (superiority or other test); UK-432,097 150 Mcg vs Placebo; p = 0.0284; NDLM estimate difference -0.0087 (95% CI -0.0943 to 0.0774) NCT00430300 ↗

registry analysis (superiority or other test); UK-432,097 450 Mcg vs Placebo; p = 0.0056; NDLM estimate difference -0.0389 (95% CI -0.1299 to 0.0471) NCT00430300 ↗

registry analysis (superiority or other test); UK-432,097 1350 Mcg vs Placebo; p = 0.0009; NDLM estimate difference -0.0510 (95% CI -0.1298 to 0.0290) NCT00430300 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	UK-432,097	Small molecule	150 ug	Inhaled
Subject	UK-432,097	Small molecule	450 ug	Inhaled
Subject	UK-432,097	Small molecule	1350 ug	Inhaled

Indications