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

NCT ID: NCT01113593

Last Updated: 2013-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Formoterol Fumarate

Intervention Type DRUG

Inhalation solution

2

Group Type EXPERIMENTAL

Formoterol Fumarate

Intervention Type DRUG

Inhalation solution

3

Group Type EXPERIMENTAL

Formoterol Fumarate

Intervention Type DRUG

Inhalation solution

4

Group Type EXPERIMENTAL

Foradil Aerolizer

Intervention Type DRUG

Dry powder inhaler

5

Group Type EXPERIMENTAL

Foradil Aerolizer

Intervention Type DRUG

Dry powder inhaler

Interventions

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Formoterol Fumarate

Inhalation solution

Intervention Type DRUG

Formoterol Fumarate

Inhalation solution

Intervention Type DRUG

Formoterol Fumarate

Inhalation solution

Intervention Type DRUG

Foradil Aerolizer

Dry powder inhaler

Intervention Type DRUG

Foradil Aerolizer

Dry powder inhaler

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dey

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clearwater, Florida, United States

Site Status

DeLand, Florida, United States

Site Status

Greenville, South Carolina, United States

Site Status

Spartanburg, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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191-089

Identifier Type: -

Identifier Source: org_study_id

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