Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema

Chronic Obstructive Pulmonary Disease Clinical Trial

— EMPHASIS  

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Pharmacodynamics, Efficacy and Safety of 50 mg Tetomilast Administered as Oral Tablets in Patients With Chronic Obstructive Pulmonary Disease Associated With Emphysema THIS STUDY IS CLOSED TO ENROLLMENT AND NEW SITES

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00874497
• Other study ID #: 197-08-250
• Status: Terminated
• Phase: Phase 2
• First received: March 31, 2009
• Last updated: June 24, 2016
• Start date: March 2009
• Est. completion date: August 2015

Study information

• Verified date: June 2016
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female, 40-75 yrs old,inclusive.

• Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.

• FEV1: FVC greater than 70% predicted.

• At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.

• Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.

Exclusion Criteria:

• Patients with asthma, active tuberculosis or bronchiectasis.

• A respiratory tract infection within 30 days prior to the screening visit.

• Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.

• Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.

• Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.

• Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.

• Subjects taking anticoagulants.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• tetomilast
Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.
• placebo
Placebo for 104 weeks (2 years)

Locations

Country	Name	City	State
United States	Georgia Clinical Research	Austell	Georgia
United States	UAB Lung Health Center	Birmingham	Alabama
United States	Texas Institute of Chest and Sleep Disorders, PA	Houston	Texas
United States	Pulmonary Disease Specialist/PDS Research	Kissimmee	Florida
United States	University of Louisville, Pulmonary Division	Louisville	Kentucky
United States	Well Pharma Medical Research	Miami	Florida
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Illinios Lung Institute	Peoria	Illinois
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Pulmonary Associates of Richmond	Richmond	Virginia
United States	Diagnostics Research Group	San Antonio	Texas
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Multicare Pulmonary Specialist	Tacoma	Washington
United States	Los Angeles Biomedical Institute	Torrance	California
United States	Florida Premier Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in trough forced expiratory volume in 1 second (FEV1) and the rate of change in the 20th percentile of lung density voxels using High Resolution Computed Tomography (HRCT)		2 years	No
Secondary	Percent change in trough FEV1		2 years	No