Chronic Obstructive Pulmonary DiseasePhase 2NCT00917150

To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 2 study testing tetomilast (OPC-6535) in people with Chronic Obstructive Pulmonary Disease, run by Otsuka Pharmaceutical Co., Ltd. at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: tetomilast (OPC-6535)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 771 participants
Where: 9 sitesin 3 countries
Study dates: Mar 2009to Apr 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

9 sites in 3 countries.

Country

City, postcode or hospital

9 sites in 3 countries

China7 sites

Study site
Central China Area
Study site
East China Area
Study site
North China Area
Study site
Northeast China Area
Study site
Northwest China Area
Study site
South China Area
Study site
Southwest China Area

Other trials in China

Japan1 site

Study site
Kansai Region, Et Al.

Other trials in Japan

South Korea1 site

Study site
Seoul, Et Al.

Other trials in South Korea

About this study

Official title: A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: tetomilast (OPC-6535), placebo
Keywords: chronic obstructive pulmonary disease, COPD, emphysema
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tetomilast (OPC-6535)Drug
oral administration of 12.5mg OPC-6535, once daily for 24months
tetomilast (OPC-6535)Drug
oral administration of 25mg OPC-6535, once daily for 24months
tetomilast (OPC-6535)Drug
oral administration of 50 mg OPC-6535, once daily for 24months
placeboDrug
oral administration of placebo, once daily for 24months

Study groups in NCT00917150
Study group	Role	What they receive
OPC-6535 12.5mg	Experimental	Not described Receives: Drug: tetomilast (OPC-6535)
OPC-6535 25mg	Experimental	Not described Receives: Drug: tetomilast (OPC-6535)
OPC-6535 50mg	Experimental	Not described Receives: Drug: tetomilast (OPC-6535)
placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months
Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period.
Measured: Baseline, 24 months

Secondary outcomes (2)

Change From Baseline at 24 Months in Total Symptom Diary Score
Subjects were required to keep a symptom diary throughout the entire trial period from the start of investigational medicinal product (IMP) administration in the washout period until the end of the treatment period. Assessment items included scores for shortness of breath, cough, and sputum, IMP compliance, use of salbutamol and respiratory symptom medications, and smoking status. Subjects recorded a score of between 0 and 3, with 0 indicating no symptoms and 3 indicating a high level of symptoms, for each domain.
Measured: Baseline, 24 months
Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score
The SGRQ is a self-administered questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being in three domains: symptoms, activity, and impact on daily life. The SGRQ was completed by each subject prior to IMP administration at baseline and at Month 6, Month 12, Month 18, and Month 24 (end of treatment).
A weighted score based on population norms for each dimension and total was evaluated. Scores were expressed as a percentage of overall impairment where 100 represented worst possible health status and 0 indicated best possible health status. Scores were calculated when less than 24% of the item scores were missing, otherwise the scores were set to missing. Where there were multiple answers for a question, the worst case was used.
Measured: Baseline, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Apr 2014

First posted10 Jun 2009 (estimated)
Study startMar 2009
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 771 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00917150
Sponsor's protocol ID: 197-08-801
Other IDs: JapicCTI-090770
Status last verified: Apr 2021
First submitted: 8 Jun 2009
Last updated: 30 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT00917150
Acronym / sponsor ID: 197-08-801
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease, COPD, emphysema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 771 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 10 Jun 2009 (estimated)
Results: Posted 30 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
OPC-6535 12.5mg	Experimental	Drug: tetomilast (OPC-6535)
OPC-6535 25mg	Experimental	Drug: tetomilast (OPC-6535)
OPC-6535 50mg	Experimental	Drug: tetomilast (OPC-6535)
placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tetomilast (OPC-6535)oral administration of 12.5mg OPC-6535, once daily for 24months	Drug	OPC-6535 12.5mg
tetomilast (OPC-6535)oral administration of 25mg OPC-6535, once daily for 24months	Drug	OPC-6535 25mg
tetomilast (OPC-6535)oral administration of 50 mg OPC-6535, once daily for 24months	Drug	OPC-6535 50mg
placebooral administration of placebo, once daily for 24months	Drug	placebo

Primary outcome

Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months
Time frame: Baseline, 24 months
Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period.

2 secondary outcomes

Change From Baseline at 24 Months in Total Symptom Diary Score
Time frame: Baseline, 24 months
Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: Baseline, 24 months

Results and safety

Results posted to the registry on 30 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-6535 12.5 mg	192	155
OPC-6535 25 mg	198	161
OPC-6535 50 mg	191	149
Placebo	190	156

Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months

Time frame: Baseline, 24 months. Mean (Standard Error). Unit: Liters

Measure	OPC-6535 12.5 mg n = 152	OPC-6535 25 mg n = 163	OPC-6535 50 mg n = 152	Placebo n = 149
Value	-0.004 (0.0481)	-0.023 (0.0481)	-0.018 (0.0473)	-0.035 (0.0480)

Population analysed: ITT population consisted of all subjects randomized to double-blind therapy, regardless of any protocol violation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration until follow-up (2 weeks after the end of treatment or early termination). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-6535 12.5 mg	47 of 192 (24.5%)	108 of 192 (56.3%)	1 of 192
OPC-6535 25 mg	47 of 196 (24%)	116 of 196 (59.2%)	5 of 196
OPC-6535 50 mg	50 of 191 (26.2%)	102 of 191 (53.4%)	3 of 191
Placebo	46 of 190 (24.2%)	105 of 190 (55.3%)	2 of 190

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tetomilast (OPC-6535) in people with Chronic Obstructive Pulmonary Disease, run by Otsuka Pharmaceutical Co., Ltd. at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months (time frame: Baseline, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00917150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.