EUCTR2015-005212-14-ROActive, not recruitingPhase 1
A phase IIIB, 24-week randomised, double-blind study to compare ‘closed’ triple therapy (FF/UMEC/VI) with 'open' triple therapy (FF/VI + UMEC), in subjects with chronic obstructive pulmonary disease (COPD) - 200812
GlaxoSmithKline Research & Development Ltd0 sites1,311 target enrollmentStarted: June 21, 2016Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,311
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. Informed Consent: A signed and dated written informed consent prior to study participation.
- •2. Type of subject: Outpatient.
- •3. Age: Subjects 40 years of age or older at Screening (V1).
- •4. Gender: Male or female subjects.
- •A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one
- •of the following conditions applies:
- •a. Non-reproductive potential defined as:
- •? Pre-menopausal females with one of the following:
- •? Documented tubal ligation
- •? Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
- •? Hysterectomy
- •? Documented Bilateral Oophorectomy
- •? Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
- •b. Reproductive potential and agrees to follow one of the options listed in the Modified
- •List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (see Appendix 5) from 30 days prior to the first dose of study treatmentand until after the last dose of study treatmentand completion of
- •the follow-up visit.
- •The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
- •5. COPD 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 at Screening (V1) [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)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Screening (V1).
- •? Pipe and/or cigar use cannot be used to calculate pack-year history.
- •7. Severity of COPD symptoms: A score of =10 on the COPD Assessment Test (CAT) at Screening (V1).
- •8. Severity of COPD Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <0.70
- •at Screening (V1).
- •9. Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening (V1).
- •? Subjects receiving only PRN COPD medications are not eligible.
- •10. History of Exacerbations: Subjects must demonstrate:
- •a post-bronchodilator FEV1 < 50% predicted normal at Screening (V1) and a documented history of = 1 moderate or severe COPD exacerbation in the 12 months prior to Screening
- •a post-bronchodilator 50% =FEV1 < 80% predicted normal at Screening (V1) and a documented history of = 2 moderate exacerbations or a documented history of =1 severe COPD exacerbation (hospitalised) in the 12 months prior to
- •Screening (V1).
- •? Percent predicted will b
Exclusion Criteria
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- •2. Asthma: Subjects with a current diagnosis of asthma.
- •3. a1-antitrypsin deficiency: Subjects with a1-antitrypsin deficiency as the underlying cause of COPD.
- •4. Other respiratory disorders: Subjects with active tuberculosis are excluded.
- •Subjects with other respiratory disorders are excluded if these conditions are the primary cause of their respiratory symptoms.
- •5. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (V1).
- •6. Risk Factors for Pneumonia: immune suppression or other risk factors for pneumonia .
- •7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening (V1) and at least 30 days following the last dose of oral/systemic corticosteroids.
- •8. Other Respiratory tract infections that have not resolved at least 7 days prior to Screening (V1)
- •9. Abnormal Chest x-ray: Chest x-ray reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest x-ray. All subjects will have a chest x-ray at Screening (V1) [or historical radiograph or CT scan obtained within 3 months prior to Screening (V1).
- •10. Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- •11. Unstable liver disease: ALT >2xULN; and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •Current active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
- •12. Unstable or life threatening cardiac disease: subjects with any of the following at Screening (V1) would be excluded:
- •-Myocardial infarction or unstable angina in the last 6 months
- •-Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months
- •-NYHA Class IV Heart failure
- •13. Abnormal and clinically significant 12-Lead ECG finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject’s medical history and exclude subjects who would be at undue risk by participating in the trial.
- •An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following:
- •-AF with rapid ventricular rate >120 BPM;
- •-sustained or nonsustained VT;
- •-Second degree heart block Mobitz type II and third degree heart block.
- •14. Contraindications: A h
Investigators
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