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

Otsuka Pharmaceutical Development & Commercialization, Inc.15 sites in 1 country84 target enrollmentMarch 2009

ConditionsChronic Obstructive Pulmonary Disease

Interventionstetomilast placebo

Drugsplacebo tetomilast

Overview

Phase: Phase 2
Intervention: tetomilast
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 84
Locations: 15
Primary Endpoint: Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

August 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

1 Tetomilast

Intervention: tetomilast

2 Placebo

Intervention: placebo

Outcomes

Primary Outcomes

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

Time Frame: Baseline to Week 104

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

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

Time Frame: Baseline to Week 104

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.

Secondary Outcomes

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)
Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV])(Baseline to Week 104)
Change From Baseline to Week 104 in Trough RV/TLC(Baseline to Week 104)
Change From Baseline to Week 104 in Trough Inspiratory Capacity(Baseline toWeek 104)
Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth)(Baseline to Week 104)
Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco)(Baseline to Week 104)
Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw)(Baseline to 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)
Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications(Baseline to Week 104)
Percentage of Participants With COPD Exacerbations by Group at Week 104(Baseline and Week 104)
Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher)(Baseline and 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)
Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum(Baseline to Week 104)