A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease

Dey Pharma

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Foradil Aerolizer; Drug: Formoterol Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113593

191-089

Details and patient eligibility

About

The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer

Enrollment: 45 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand the requirements of the study and provide 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: Crossover Assignment

Masking: Quadruple Blind

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45 participants in 5 patient groups

1

Experimental group

Treatment:

Drug: Formoterol Fumarate

Drug: Formoterol Fumarate

Drug: Formoterol Fumarate

2

Experimental group

Treatment:

Drug: Formoterol Fumarate

Drug: Formoterol Fumarate

Drug: Formoterol Fumarate

3

Experimental group

Treatment:

Drug: Formoterol Fumarate

Drug: Formoterol Fumarate

Drug: Formoterol Fumarate

4

Experimental group

Treatment:

Drug: Foradil Aerolizer

Drug: Foradil Aerolizer

5

Experimental group

Treatment:

Drug: Foradil Aerolizer

Drug: Foradil Aerolizer