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

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ClinicalTrials.gov Identifier: NCT01113593
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Dey

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2010
Actual Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dey
ClinicalTrials.gov Identifier: NCT01113593     History of Changes
Other Study ID Numbers: 191-089
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by Dey:
COPD

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