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Trial record 1 of 1 for:    Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients with Moderate to Very Severe COPD with a History of Exacerbations
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Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History (GALATHEA)

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ClinicalTrials.gov Identifier: NCT02138916
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies

Condition or disease Intervention/treatment Phase
Moderate to Very Severe Chronic Obstructive Pulmonary Disease Drug: Benralizumab Arm A Drug: Benralizumab Arm B Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1656 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients With Moderate to Very Severe COPD With a History of Exacerbations
Actual Study Start Date : June 13, 2014
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : April 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Benralizumab Arm A
Benralizumab administered subcutaneously
Drug: Benralizumab Arm A
Benralizumab subcutaneously on study week 0 until study week 48 inclusive

Experimental: Benralizumab Arm B
Benralizumab administered subcutaneously
Drug: Benralizumab Arm B
Benralizumab subcutaneously on study week 0 until study week 48 inclusive

Placebo Comparator: Placebo
Placebo administered subcutaneously
Drug: Placebo
Placebo subcutaneously on study week 0 until study week 48 inclusive




Primary Outcome Measures :
  1. Evaluation of the effect of benralizumab on COPD exacerbations in subjects with moderate to very severe COPD [ Time Frame: Immediately following administration of study drug up to 56 weeks ]
    Annual COPD (Chronic Obstructive Pulmonary Disease) exacerbation rate.


Secondary Outcome Measures :
  1. Evaluation of the effect of benralizumab on health status/health-related quality of life [ Time Frame: up to 56 weeks ]
    St. George's Respiratory Questionnaire (SGRQ), Chronic Obstructive Pulmonary Disease assessment tool (CAT)

  2. Evaluation of the effect of benralizumab on pulmonary function [ Time Frame: up to 56 weeks ]
    Pre-dose/pre-bronchodilator Forced expiratory volume in one second (FEV1) at the study center

  3. Evaluation of the effect of benralizumab on respiratory symptoms [ Time Frame: up to 56 weeks ]
    Baseline/Transitional Dyspnea Index (BDI/TDI)

  4. Evaluation of the effect of benralizumab on rescue medication use [ Time Frame: up to 56 weeks ]
    Total rescue medication use (average puffs/day), recorded by patient using electronic diary

  5. Evaluation of the effect of benralizumab on nocturnal awakenings [ Time Frame: Up to 56 weeks ]
    Number of nights with awakening due to COPD, recorded by patient using electronic diary.

  6. Evaluation of the effect of benralizumab on the severity, frequency and duration of Exacerbations of Chronic Pulmonary Disease Tool (EXACT-PRO) - Patient-reported Outcome questionnaire defined events [ Time Frame: Up to 56 weeks. ]
    Exacerbations of Chronic Pulmonary Disease Tool (EXACT-PRO) - Patient-reported Outcome questionnaire

  7. Evaluation of the effect of benralizumab on healthcare resource utilization due to COPD [ Time Frame: up to 56 weeks ]
    Annual rate of hospitalizations, combined hospitalizations and emergency department visits, unscheduled visits and healthcare encounters due to COPD

  8. Evaluation of the pharmacokinetics parameters of benralizumab. [ Time Frame: up to 60 weeks ]
    Pharmacokinetics (PK) - steady-state serum pre-dose concentration

  9. Assessment of the safety and tolerability of benralizumab [ Time Frame: From baseline visit up to 56 weeks. ]
    Adverse Events/ Serious Adverse Events (AE/SAE) - Laboratory variables - 12 lead Electrocardiogram (ECG)- Physical Examination - Vital Signs

  10. Evaluation of the immunogenicity of benralizumab [ Time Frame: up to 60 weeks ]
    Determination of Anti-drug antibodies (ADA)


Other Outcome Measures:
  1. Evaluation of the effect of benralizumab on general health status [ Time Frame: up to 56 weeks ]
    European Quality of Life-5 Dimensions (EQ-5D-5L) questionnaire

  2. Evaluation of the impact of benralizumab on blood eosinophil levels [ Time Frame: Up to 60 weeks ]
    Blood eosinophils levels



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1.Informed consent. 2.Subjects 40-85 y.o. 3.Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%. 4.≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. 5. Modified Medical Research Council (mMRC) score ≥1 at Visit 1. 6.Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1. 7.Tobacco history of ≥10 pack-years. 8.Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1. 9.Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose. 10.Compliance with maintenance therapy during run-in ≥70%. 11. Blood eosinophils due to subject's stratification and cap for blood eosinophil levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study. Exclusion criteria: 1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

2. Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety−study findings or their interpretation or subject's ability to complete the entire study duration.

3. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.

4. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.

5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1or during the enrolment and run-in period.

6. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.

7. Pregnant, breastfeeding, or lactating women. 8. Risk factors for pneumonia 9. History of anaphylaxis to any other biologic therapy. 10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.

11. Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.

12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.

13. Evidence of active tuberculosis (TB) without an appropriate course of treatment.

14. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).

15. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.

16. Previous treatment with benralizumab. 17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138916


  Show 408 Study Locations
Sponsors and Collaborators
AstraZeneca
MedImmune LLC
Investigators
Principal Investigator: Gerard Criner, MD Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02138916     History of Changes
Other Study ID Numbers: D3251C00003
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Keywords provided by AstraZeneca:
Obstructive Lung Diseases
Chronic Obstructive Pulmonary Disease
Lung Disease
Bronchial Diseases
COPD Exacerbation
Respiratory Tract Diseases

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases