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

A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00783406

Acronym

A7881010

Enrollment

Registered

2008-10-31

Start date

2008-10-31

Completion date

2009-03-31

Last updated

2010-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Brief summary

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.

Interventions

DRUGPF-00610355

dry powder inhaler, 1472 mcg, single dose

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients	up to 24 hours post dose
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.	up to 8 days post dose

Secondary

Measure	Time frame
To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.	up to 24 hours post dose
To investigate the exposure/response relationship of PF-00610355.	up to 8 days post dose

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026