EUCTR2015-005212-14-ITActive, 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 AND DEVELOPMENT0 sites1,311 target enrollmentStarted: September 29, 2016Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- 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 at the paragrapgh 5.1 in the protocol.
- •b. Reproductive potential and agrees to follow one of the options listed in the Appendix 5 of the protocol 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.
- •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.
- •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).
- •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).
- •11. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social securitycategory.
- •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 510
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 510
Exclusion Criteria
- •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.
- •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 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
- •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.
- •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
- •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 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 history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2- agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or
- •bladder neck obstruction that, in the opinion of the investigator contraindicates study participation.
- •15. Cancer: Subjects with carcinoma that has not been in complete remission for at least 3 years. Subjects who have had carcinoma in situ
- •of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 3 year waiting period if the
- •subject has been considered cured
Investigators
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