Clinical trial NCT00874497: Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline to Week 104
measure: Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels
timeFrame: Baseline to Week 104
Secondary outcomes:
measure: Percent Change From Baseline in Trough FEV1 From Baseline to Week 104
timeFrame: Baseline to Week 104
measure: Density Mask Score Based on Specified Thresholds Including -950 HU
timeFrame: Baseline and Week 104
measure: 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
timeFrame: Baseline to Week 104
measure: Observed Rate of Change in Emphysema From Baseline to Week 104
timeFrame: Baseline to Week 104
measure: Change From Baseline to Week 104 in Cumulative Frequency of HU
timeFrame: Baseline and Week 104
measure: Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV])
timeFrame: Baseline to Week 104
measure: Change From Baseline to Week 104 in Trough RV/TLC
timeFrame: Baseline to Week 104
measure: Change From Baseline to Week 104 in Trough Inspiratory Capacity
timeFrame: Baseline toWeek 104
measure: Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth)
timeFrame: Baseline to Week 104
measure: Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco)
timeFrame: Baseline to Week 104
measure: Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw)
timeFrame: Baseline to Week 104
measure: Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum
timeFrame: Baseline to Week 104
measure: Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications
timeFrame: Baseline to Week 104
measure: Percentage of Participants With COPD Exacerbations by Group at Week 104
timeFrame: Baseline and Week 104
measure: Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher)
timeFrame: Baseline and Week 104
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lung Health Center
state: Alabama
city: Torrance
country: United States
facility: Los Angeles Biomedical Institute
state: California
city: Kissimmee
country: United States
facility: Pulmonary Disease Specialist/PDS Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: Winter Park
country: United States
facility: Florida Premier Research Institute
state: Florida
city: Austell
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Peoria
country: United States
facility: Illinios Lung Institute
state: Illinois
city: Louisville
country: United States
facility: University of Louisville, Pulmonary Division
state: Kentucky
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Houston
country: United States
facility: Texas Institute of Chest and Sleep Disorders, PA
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond
state: Virginia
city: Tacoma
country: United States
facility: Multicare Pulmonary Specialist
state: Washington
Study officials:
References: