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

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Pfizer

Status and phase

Completed
Phase 2

Conditions

Chronic Obstructive Airway Disease
Lung Diseases
Respiratory Tract Diseases
Pulmonary Disease, Chronic Obstructive
COPD

Treatments

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

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: Low Dose PF-03635659
Drug: Mid Dose PF-03635659

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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