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

Dey Pharma

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: fluticasone propionate/formoterol fumarate; Drug: formoterol fumarate; Drug: fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00774761

191-087

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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97 participants in 5 patient groups

1

Experimental group

Treatment:

Drug: fluticasone propionate/formoterol fumarate

2

Experimental group

Treatment:

Drug: fluticasone propionate/formoterol fumarate

3

Active Comparator group

Treatment:

Drug: fluticasone propionate

4

Active Comparator group

Treatment:

Drug: fluticasone propionate

5

Active Comparator group

Treatment:

Drug: formoterol fumarate