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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113593
• Other study ID #: 191-089
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2010
• Last updated: May 17, 2013
• Start date: May 2010

Study information

• Verified date: May 2013
• Source: Dey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Formoterol Fumarate
Inhalation solution
• Formoterol Fumarate
Inhalation solution
• Formoterol Fumarate
Inhalation solution
• Foradil Aerolizer
Dry powder inhaler
• Foradil Aerolizer
Dry powder inhaler

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 hours on Day 1 and Day 7 of dosing during each treatment period	Yes