EUCTR2014-002340-40-GB进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled 2-Way Crossover Study to Evaluate the Efficacy, Safety and Tolerability of PF-03715455 Administered Twice Daily By Inhalation for 4 Weeks in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Female subjects of non-childbearing potential and male subjects between the ages of 40 and 80 years, inclusive.
- •Female subjects of non-childbearing potential must meet at least one of the following criteria:
- •a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle-stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal women.
- •b. Have undergone a documented hysterectomy and/or bilateral oophorectomy.
- •c. Have medically confirmed ovarian failure.
- •All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
- •2. Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD1) and who meet the criteria for Stage II-III disease:
- •- Subjects must have a post-bronchodilator FEV1/FVC ratio <0.7 and a postbronchodilator FEV1 of 30-80% (inclusive) of the predicted value for age, height, race and sex using European Community for Coal and Steel (ECCS) standards. To qualify for randomization these criteria must be met at both screening and the run-in viisit.
- •3. Subjects must have a smoking history of =10 pack-years* and meet one of the following criteria:
- •- They are current smokers, or
- •- They are ex-smokers who have abstained from smoking for at least 6 months.
- •*Formula for pack-years:
- •For cigarettes = (average number of cigarettes/day ÷ 20) x years of smoking,
- •For tobacco = ounces per week x 2/7 x years of smoking.
- •4. Subjects must have had stable COPD (for at least 3 months prior to screening. During the screening and run-in phase subjects must be able to manage disease symptoms adequately on bronchodilators alone without the need for other therapies.
- •5. Subjects must have an mMRC score at screening which is =1.
- •6. Subjects must be able to complete spirometry assessments according to American Thoracic Society/ European Respiratory Society (ATS/ERS) guidelines.
- •7. Body Mass Index (BMI) of <35 kg/m2; and a total body weight >40 kg.
- •8. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •9. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Additional Inclusion Criteria for Sputum Sub-Study:
- •1. Subjects must be able to produce a sputum sample, at screening and randomization, which is sufficient to provide a differential count (<20% squamous cells) and a minimum of 0.1 g in sputum weight after induction with inhaled hypertonic saline.
- •2. Subjects must have a sputum sample which has >50% neutrophils at screening.
- •In the event that a subject meets all other Screening criteria but does not provide an evaluable sputum sample they may still be entered into the non-sputum study providing recruitment is still open.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Current evidence or history within the previous 6 months of any clinically 1. significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data
- •2. Subjects who have clinically significant (as deemed by investigator) abnormalities on physical examination, 12-lead ECG and vital signs (blood pressure and pulse) that would increase the risk to the patient or interfere with the interpretation of the safety or efficacy results.
- •3. A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of Screening.
- •4. History of a lower respiratory tract infection or significant COPD disease instability during the 3 months preceding screening or during the time between screening and randomization.
- •5. History of an upper respiratory tract infection in the 4 weeks preceding screening or during the time between screening and randomization.
- •6. Use of inhaled corticosteroids within 3 months of Screening.
- •7. History or presence of respiratory failure, cor pulmonale or right ventricular failure.
- •8. Subjects with home oxygen therapy or long-term oxygen therapy.
- •9. Known history of adult asthma or other chronic respiratory disorders (eg, tuberculosis, bronchiectasis, pulmonary fibrosis, pneumoconiosis).
- •10. History of cancer (other than basal cell carcinoma or treated cervical carcinoma in situ) within the previous 5 years.
- •11. Symptoms, signs or laboratory findings (screening only) suggestive of an ongoing infective illness.
- •12. Participation in any clinical study with any investigational drug or marketed investigational biologic in the 4 months or 5 half-lives prior to the screening visit, whichever is longer.
- •13. ECG abnormalities at screening or randomisation including those listed below:
- •a. Subjects with pre-randomization evidence of QTcF prolongation (defined as >450 ms for males and >470 ms for females) are not eligible for randomization. This assessment is based on a confirmed mean of the triplicate ECG recordings.
- •b. Predominant heart rhythm other than normal sinus rhythm eg, atrial fibrillation, atrial flutter, supraventricular tachycardia.
- •c. Atrioventricular (AV) block greater than first degree.
- •d. Resting heart rate >100 or <40 bpm.
- •e. Evidence of previous myocardial infarction in the absence of clinical history associated with these findings.
- •f. Evidence of acute ischemia.
- •14. Known previous diagnosis of Hepatitis B or C or human immunodeficiency virus (HIV) infection.
- •15. Subjects with ANY of the following abnormalities in clinical laboratory tests at screening:
- •Aspartate transaminase (AST)/ serum glutamic oxaloacetic transminase (SGOT) or alanine transaminase (ALT)/ serum glutamic pyruvic transminase (SGPT) >1.5 x upper limit of normal (ULN).
- •Total bilirubin >1.5 x ULN.
- •Albumin <3.5 g/dL due to known liver disease.
- •Serum creatinine >1.5 x ULN.
- •Hgb <10 g/dL, Hct <32%.
- •Absolute white blood count (WBC) count <3.0 x 109/L (<3000/mm3).
- •Neutrophil count <1.2 x 109/L (<1200/mm3).
- •Platelet count <120 x 109/L (<120,000/mm3).
- •16. Male subjects with partners who are currently pregnant; male subjects of child bearing potential (who are at risk for pregnancy with their female partners) and unwilling or unable to use a highly effective method of contraception.
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