Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients. (A7881010)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: PF-00610355

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783406

A7881010

Details and patient eligibility

About

This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post-bronchodilator FEV1/ FVC ratio of <0.7.
• Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
• Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
• Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.

Exclusion criteria

• Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
• History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

PF- 00610355

Experimental group

Treatment:

Drug: PF-00610355

Drug: PF-00610355

Drug: PF-00610355

PF-00610355

Experimental group

Treatment:

Drug: PF-00610355

Drug: PF-00610355

Drug: PF-00610355

PF -00610355

Experimental group

Treatment:

Drug: PF-00610355

Drug: PF-00610355

Drug: PF-00610355

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo