A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients. (A7881013)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Salmeterol; Drug: PF-00610355; Drug: PF - 00610355; Drug: Placebo; Drug: PF- 00610355

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808288

A7881013

Details and patient eligibility

About

To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

Enrollment: 405 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
• Diagnosis of moderate COPD for a minimum of 6 months.
• Stable disease for at least 1 month prior to screening

Exclusion criteria

• More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
• History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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405 participants in 5 patient groups, including a placebo group

PF-00610355

Experimental group

Treatment:

Drug: PF-00610355

PF- 00610355

Experimental group

Treatment:

Drug: PF - 00610355

PF - 00610355

Experimental group

Treatment:

Drug: PF- 00610355

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Salmeterol

Active Comparator group

Treatment:

Drug: Salmeterol