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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dey
ClinicalTrials.gov Identifier:
NCT01113593
First received: April 27, 2010
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Formoterol Fumarate
Drug: Foradil Aerolizer
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Dey:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Formoterol Fumarate
Inhalation solution
Experimental: 2 Drug: Formoterol Fumarate
Inhalation solution
Experimental: 3 Drug: Formoterol Fumarate
Inhalation solution
Experimental: 4 Drug: Foradil Aerolizer
Dry powder inhaler
Experimental: 5 Drug: Foradil Aerolizer
Dry powder inhaler

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113593

Locations
United States, Florida
Clearwater, Florida, United States
Deland, Florida, United States
United States, South Carolina
Greenville, South Carolina, United States
Spartanburg, South Carolina, United States
Sponsors and Collaborators
Dey
  More Information

No publications provided

Responsible Party: Dey
ClinicalTrials.gov Identifier: NCT01113593     History of Changes
Other Study ID Numbers: 191-089
Study First Received: April 27, 2010
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014