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Completed

NCT Number: NCT00917150

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

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

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Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central China Area, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tetomilast (OPC-6535)

Drug

oral administration of 12.5mg OPC-6535, once daily for 24months

Placebo

Drug

oral administration of placebo, once daily for 24months

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change From Baseline at 24 Months in Total Symptom Diary Score

    Time frame: Baseline, 24 months

    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.

  2. Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score

    Time frame: Baseline, 24 months

    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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2009
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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