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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: UK-432,097

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430300

A3971013

Details and patient eligibility

About

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

Enrollment: 87 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
• Patients must have a smoking history of at least 10 pack-years
• Patients must have stable disease for at least 1 month prior to screening.

Exclusion criteria

• More than 2 exacerbations of COPD in the preceding year
• History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
• History or presence of respiratory failure, cor pulmonale or right ventricular failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups, including a placebo group

150mcg, 450mcg or 1350mcg

Experimental group

Description:

Active treatment given BID via a double pin monodose capsule inhaler device

Treatment:

Drug: UK-432,097

Placebo

Placebo Comparator group

Description:

Placebo treatment given BID via a single pin monodose inhaler device

Treatment:

Drug: Placebo