A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00774761

Enrollment

Registered

2008-10-17

Start date

2008-11-30

Completion date

2009-05-31

Last updated

2013-05-20

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic, Obstructive, Pulmonary, Disease, COPD, Pharmacodynamic, Pharmacokinetic

Brief summary

The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.

Interventions

DRUGfluticasone propionate/formoterol fumarate

inhalation suspension

DRUGfluticasone propionate

inhalation suspension

DRUGformoterol fumarate

inhalation solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Able to understand the requirements of the study and provide consent * Medical diagnosis of COPD * A current or prior history of at least 10-pack years of cigarette smoking * Female of child-bearing potential to use adequate birth control

Exclusion criteria

* Diagnosis of asthma * Other significant disease than COPD * Has donated a unit of blood within 30 days of study, or intends to donate * QTc greater than 0.460 seconds * Subjects who had radiation or chemotherapy in the previous 12 months * Subjects who had lung resection * History of illegal drug abuse or alcohol abuse within the past 5 years

Design outcomes

Primary

Measure	Time frame
Plasma AUC(0-t) after 1 week of dosing	PK sampling over 24 hrs

Secondary

Measure	Time frame
FEV1	pre-dose and 2 hrs post-dose

Countries

United States

Outcome results

None listed

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