A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Airway Disease; Lung Diseases; Respiratory Tract Diseases; Pulmonary Disease, Chronic Obstructive; COPD

Treatments: Drug: High Dose PF-03635659; Drug: active comparator; Drug: Mid Dose PF-03635659; Drug: Low Dose PF-03635659; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01033487

B0431010

Details and patient eligibility

About

PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Enrollment: 22 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
• Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
• 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

---

22 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

active comparator

Active Comparator group

Treatment:

Drug: active comparator

PF-03635659

Experimental group

Treatment:

Drug: High Dose PF-03635659

Drug: Mid Dose PF-03635659

Drug: Low Dose PF-03635659