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

Dey Pharma

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Formoterol Fumarate; Drug: Fluticasone Propionate/Formoterol Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01168310

191-090

Details and patient eligibility

About

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.

Enrollment: 468 patients

Sex: All

Ages: 40+ days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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468 participants in 7 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

2

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

3

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

4

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

5

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

6

Active Comparator group

Treatment:

Drug: Formoterol Fumarate

7

Placebo Comparator group

Treatment:

Drug: Placebo