EUCTR2014-000611-14-DE进行中（未招募）不适用
A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive Pulmonary Disease COPD
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
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. Type of subject: Outpatient.
- •2. Informed Consent: A signed and dated written informed consent prior to study participation.
- •3. Age: Subjects 40 years of age or older at Visit 1.
- •4. Gender: Male and female subjects are eligible to participate in the study.
- •Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow-up contact):
- •- Abstinence
- •- Oral Contraceptive, either combined or progestogen alone
- •- Injectable progestogen
- •- Implants of levonorgestrel
- •- Estrogenic vaginal ring
- •- Percutaneous contraceptive patches
- •- Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label
- •- Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records.
- •- Double barrier method: condom and an occlusive cap (diaphragm or
- •cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
- •5. Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004].
- •6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of = 10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history.
- •7. Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 of =70% of predicted normal values at Visit 1 (Screening) calculated using reference values provided by Quanjer [Quanjer, 2012].
- •8. Current clinically prescribed medication: The subject must be on the dose and frequency of one of the following ICS/LABA combinations approved for COPD at least 30 days prior screening
- •- FSC at a dose of 500/50mcg twice-daily (i.e. Seretide Diskus or approved generic productsuch as AirFluSal Forspiro500/50mcg twice daily or Rolenium Elpenhaler 500/50mcg twice daily)
- •- The combination of budesonide/formoterol (i.e., Symbicort Turbuhaler) at doses of 200/6 mcg twice-daily or 400/12mcg twice-daily .
- •- ICS/LABA combinations (including generics) approved for COPD at approved doses and frequency not mentioned above but stipulated in the SPM.
- •9. Dyspnea: A score of =2 on the mMRC Dyspnea Scale at Visit 1.
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- •2. Asthma: A current diagnosis of asthma.
- •3. Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. Please view protocol for further information.
- •4. Other Diseases/Abnormalities: The subject is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediately life-threatening illness e.g. cancer.
- •5. Contraindications: Any history of allergy or hypersensitivity to any
- •anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate. .
- •6. Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
- •7. Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
- •8. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
- •9. Unstable or life threatening cardiac disease: Umeclidinium should be used with caution in subjects with severe cardiovascular disease. Please view protocol for further information.
- •10.12-Lead ECG: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Please view protocol for further information.
- •11.Antimuscarinic effects: Subjects with medical conditions such as narrow-angle glaucoma, prostatic hypertrophy, or bladder neck obstruction should only be included if, in the opinion of the study physician, the benefit outweighs the risk.
- •12.Interactions: Concomitant administration with beta-blockers and strong CYP3A4 inhibitors is only permitted if, in the Investigator’s opinion, the likely benefit outweighs the potential risk.
- •13.Severe Hepatic Impairment: Patients with severe hepatic impairment (Child- Pugh class C) should be excluded unless, in the opinion of the investigator, the benefit is likely to outweigh the risk.
- •14.Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
- •15.Medications Prior to Screening: please view table and further information within the protocol.
- •16.Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., 12 hours per day) is not exclusionary.
- •17.Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy.
- •18.Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1, or who will enter the acute phase of a pulmonary rehabilitation program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
- •19.Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
- •20.Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, subinvestigator, study coordinator, or employee of the participating i
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