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

NCT00874497 | Terminated Phase 2 Results

• 1 other identifier: 197-08-250
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)

  The analysis of the change from Baseline to Week 104 (last observation carried forward \[LOCF\]) in trough FEV1 is presented below.

  Baseline to Week 104

• Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels

  The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit \[HU\] using quantitative HCRT) by visit and lung region is presented below.

  Baseline to Week 104

Secondary Outcomes (15)

• Percent Change From Baseline in Trough FEV1 From Baseline to Week 104

  Baseline to Week 104

• Density Mask Score Based on Specified Thresholds Including -950 HU

  Baseline and Week 104

• Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104

  Baseline to Week 104

• Observed Rate of Change in Emphysema From Baseline to Week 104

  Baseline to Week 104

• Change From Baseline to Week 104 in Cumulative Frequency of HU

  Baseline and Week 104

Study Arms (2)

1 Tetomilast

EXPERIMENTAL

Drug: tetomilast

2 Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

tetomilast DRUG

Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.

1 Tetomilast

placebo DRUG

Placebo for 104 weeks (2 years)

2 Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (15)

UAB Lung Health Center

Birmingham, Alabama, 35294, United States

Location

Los Angeles Biomedical Institute

Torrance, California, 90502, United States

Location

Pulmonary Disease Specialist/PDS Research

Kissimmee, Florida, 34741, United States

Location

Well Pharma Medical Research

Miami, Florida, 33143, United States

Location

Florida Premier Research Institute

Winter Park, Florida, 32789, United States

Location

Georgia Clinical Research

Austell, Georgia, 30106, United States

Location

Illinios Lung Institute

Peoria, Illinois, 61606, United States

Location

University of Louisville, Pulmonary Division

Louisville, Kentucky, 40202, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Texas Institute of Chest and Sleep Disorders, PA

Houston, Texas, 77034, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Pulmonary Associates of Richmond

Richmond, Virginia, 23225, United States

Location

Multicare Pulmonary Specialist

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tetomilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This trial was terminated early, not due to a safety concern, but due to a business decision to cease development of the tetolimast clinical program.

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 2, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-03

Locations

US (15)