Phase 2
N=771
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00917150 ↗Enrolled (actual)
771
Serious AEs
24.7%
Results posted
Apr 2021
Primary outcome: Primary: Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months — -0.004; -0.023; -0.018; -0.035 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tetomilast (OPC-6535) (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months |
-0.004; -0.023; -0.018; -0.035 | — |
| SECONDARY Change From Baseline at 24 Months in Total Symptom Diary Score |
0.063; 0.073; 0.077; 0.101 | — |
| SECONDARY Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score |
-9.6; -7.9; -7.7; -10.4 | — |
Summary
To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.
Eligibility Criteria
Inclusion Criteria
- Age 40 to 75 years, inclusive, at the time informed consent is obtained
- Ability to provide own written informed consent
- Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)
- A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening
- Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening
- Cigarette smoking history of at least 20 pack years at screening
Exclusion Criteria
- Subjects with obstructive disorders due to bronchial asthma
- Subjects receiving long-term oxygen therapy
- Subjects with active tuberculosis or obvious bronchiectasis
- Complication of malignant tumor
- Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders
- Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)
Data sourced from ClinicalTrials.gov (NCT00917150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.