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

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

Completed

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clearwater, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

formoterol fumarate

Drug

Inhalation solution

Foradil Aerolizer

Drug

Dry powder inhaler

Primary outcomes

Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil

Time frame: 12 hours on Day 1 and Day 7 of dosing during each treatment period

Sponsors and collaborators

Lead sponsor

Dey

Industry

Registry information

Official study title

A Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects With Stable Chronic Obstructive Pulmonary Disease

Important dates

Study start: 2010
Primary completion: 2010
First posted: Apr 30, 2010
Registry last updated: May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed