EUCTR2007-004684-22-DE进行中（未招募）不适用
An exploratory, double-blind, randomized, placebocontrolled, 2-way cross-over study to assess the effect of repeat-dose inhaled indacaterol maleate (300 mcg) on dynamic and static lung hyperinflation, subjective breathlessness and health status in patients with COPD.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female (see exclusion criteria 8 below) patients with COPD, aged 40-80 years, with a smoking history of at least 20 pack years (i.e. smokers or ex-smokers).
- •2. Prior to administration of any study procedures, all subjects must understand and provide written informed consent. Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study
- •3. Diagnosis of COPD according to GOLD criteria
- •4. Body mass index (BMI) must be within the range of 18 to 32 kg/m2. Patients must weigh at least 50 kg to participate in this study.
- •5. Post-bronchodilator* 40% = FEV1 at screening = 80% of the predicted normal value
- •6. Post-bronchodilator* FEV1/FVC < 70%
- •7. Increase in FEV1 from Pre-bronchodilator to Post-bronchodilator assessment of at least 5%
- •8. Demonstrated plethysmographic functional residual capacity > 120% predicted normal
- •9. No history of concomitant lung disease such as asthma, carcinoma, active TB or prior thoracic surgery. No requirement for long term oxygen treatment or history of lung reduction surgery. No medical conditions that would interfere with the performance of spirometry or cardiopulmonary exercise testing, serum CPK levels must be in the normal range as measured by point-of-care or lab assay at screening and prior to all protocol specified exercise testing.
- •10. Male patients must be using a double-barrier local contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child in the three (3) months following last study drug administration.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5 mIU/mL)
- •2. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 2 or during the run-in period
- •3. Patients requiring oxygen therapy or who experience oxygen desaturation to <80% during cycle exercise on room air according to the methodology used by the investigator and in the opinion of the investigator should not participate in the study.
- •4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. Patients who develop a respiratory tract infection prior to randomization must discontinue from the trial, but may be permitted to re-enroll at a later date (at least 6 weeks after the end of the respiratory tract infection)
- •5. Patients with contra-indications of cardiopulmonary exercise testing:
- •6. Patients with significant (investigator evaluation) concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis
- •7. Patients with a history of asthma indicated
- •8. Women of child-bearing potential
- •9. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
- •10. Any patient with lung cancer or a history of lung cancer
- •11. Any patient with active cancer or a history of cancer with less than 5 years disease free
- •survival time (whether or not there is evidence of local recurrence or metastases).
- •Localized basal cell carcinoma (without metastases) of the skin is acceptable. Patients
- •with a history of cancer (excluding lung cancer) and 5 years or more disease free survival
- •time may be included in the study at the investigator’s discretion on a case-by-case basis
- •12. History of immunodeficiency diseases, including a positive HIV (ELISA and Western
- •blot) test result.
- •13. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •14. Patients with a history of long QT syndrome or whose QTc interval (Bazett’s) measured at Screening or Visit 4 is prolonged: > 430 ms (males) or > 450 ms (females) as assessed by the investigator. Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened.
- •15. Patients with a history of hypersensitivity to any of the study drugs or to drugs with
- •similar chemical structures including untoward reactions to sympathomimetic amines or
- •inhaled medication or any component thereof
- •16. Patients who have had treatment with investigational drugs at the time of enrollment, or
- •within 30 days or 5 half-lives prior to screening.
- •17, 18, 19 Disallowed medications including treatments for COPD and allied conditions and other conditions: (please see protocol for washout times prior to screening and excluded meds, meds allowed if stabilized, and other excluded medications)
- •20. Patients unable to successfully use a dry powder inhaler device or perform spirometry
- •measurements
研究者
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