A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01168310

Enrollment

468

Registered

2010-07-23

Start date

2010-08-31

Completion date

2011-10-31

Last updated

2013-05-27

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

Pulmonary, Obstructive, lungs, COPD

Brief summary

This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.

Interventions

DRUGFluticasone Propionate/Formoterol Fumarate

Inhalation Suspension

DRUGFormoterol Fumarate

Inhalation Solution

DRUGPlacebo

Inhalation Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Days to No maximum

Healthy volunteers

Inclusion criteria

* Able to understand the requirements of the study and provide written informed consent * A clinical diagnosis of COPD * A current or prior history of at least 10-pack years of cigarette smoking * Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study

Exclusion criteria

* A clinical diagnosis of Asthma * Other significant disease than COPD * Subjects who radiation or chemotherapy within the previous 12 months * Subjects who had any lung resection * QTcB greater than 0.460 seconds * History of illegal drug abuse or alcohol abuse within the past 5 years

Design outcomes

Primary

Measure	Time frame
Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD	12 Weeks

Secondary

Measure	Time frame
Incidence of adverse events (AEs)	12 Weeks

Countries

United States

Outcome results

None listed

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