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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
Results First Posted : June 13, 2019
Last Update Posted : June 13, 2019
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

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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. Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL [ Time Frame: From first IP to week 56 ]

    A COPD exacerbation is defined by symptomatic worsening of COPD requiring:

    • Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
    • Use of antibiotics; and/or
    • An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.


Secondary Outcome Measures :
  1. Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL [ Time Frame: From first IP to week 56 ]

    A COPD exacerbation is defined by symptomatic worsening of COPD requiring:

    • Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
    • Use of antibiotics; and/or
    • An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

  2. Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL [ Time Frame: First IP up to end of treatment Week 56 ]
    Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.

  3. Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL [ Time Frame: First IP up to Week 56 ]
    SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.

  4. Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL [ Time Frame: First IP up to Week 56 ]
    CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.

  5. Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL [ Time Frame: First IP up to Week 56 ]
    The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.

  6. Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL [ Time Frame: First IP up to Week 56 ]
    The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.

  7. Mean Change From Baseline in Proportion of Nights Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL [ Time Frame: First IP up to Week 56 ]
    Change from baseline to week 56 in proportion of nights awakenings due to respiratory symptoms.

  8. Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL [ Time Frame: Immediately following first IP up to week 56 ]
    The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Exacerbation event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an exacerbation event has occurred.

  9. Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL [ Time Frame: Immediately following first IP up to week 56 ]
    The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity for the study is the highest score of EXACT-PRO.

  10. Duration of EXACT-PRO for Patients With Baseline EOS>=220/uL [ Time Frame: Immediately following first IP up to week 56 ]
    The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Calculation of event duration after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.

  11. Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL [ Time Frame: Immediately following first IP up to week 56 ]
    The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

  12. Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL [ Time Frame: Immediately following first IP up to week 56 ]
    A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.

  13. Time to First COPD Exacerbation [ Time Frame: Immediately following first IP up to week 56 ]
    Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation

  14. Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL [ Time Frame: Immediately following first IP up to week 56 ]
    Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

  15. Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL [ Time Frame: Immediately following first IP up to week 56 ]
    Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.

  16. Duration of Study Treatment Administration [ Time Frame: From first dose date to last dose date, 48 weeks per protocol. ]
    Duration of study treatment is calculated from first dose date to last dose date + 1 day.

  17. Serum Concentration of Benralizumab [ Time Frame: Pre-first dose and pre-dose at end of treatment (week 56) ]
    PK serum samples were collected pre-dose at each visit.

  18. Immunogenicity of Benralizumab [ Time Frame: Pre-treatment until end of follow-up, week 60 per protocol. ]
    Antidrug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented



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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


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Nagaoka-shi, Japan, 940-8621
Research Site
Nagoya-shi, Japan, 454-8509
Research Site
Nagoya-shi, Japan, 455-8530
Research Site
Niigata-shi, Japan, 950-2085
Research Site
Obihiro-shi, Japan, 080-0805
Research Site
Ohota-ku, Japan, 145-0063
Research Site
Ota-shi, Japan, 373-8585
Research Site
Saiki-shi, Japan, 876-0813
Research Site
Sakai-shi, Japan, 591-8555
Research Site
Sakaide-shi, Japan, 762-8550
Research Site
Sapporo-shi, Japan, 001-0901
Research Site
Sapporo-shi, Japan, 060-0033
Research Site
Sapporo-shi, Japan, 063-0005
Research Site
Sapporo-shi, Japan, 064-0804
Research Site
Sendai-shi, Japan, 984-8560
Research Site
Seto-shi, Japan, 489-8642
Research Site
Shinagawa-ku, Japan, 142-8666
Research Site
Shinjuku-ku, Japan, 162-8655
Research Site
Takamatsu-shi, Japan, 761-8073
Research Site
Takatsuki-shi, Japan, 569-1096
Research Site
Toon-shi, Japan, 791-0281
Research Site
Toshima-ku, Japan, 171-0014
Research Site
Ube-shi, Japan, 755-0241
Research Site
Ueda-shi, Japan, 386-8610
Research Site
Uji-shi, Japan, 611-0041
Research Site
Urasoe-shi, Japan, 901-2132
Research Site
Uruma-shi, Japan, 904-2293
Research Site
Yachiyo-shi, Japan, 276-8524
Research Site
Yanagawa-shi, Japan, 832-0059
Research Site
Yao-shi, Japan, 581-0011
Research Site
Yokohama-shi, Japan, 232-0024
Research Site
Yokohama-shi, Japan, 234-0054
Research Site
Yokohama-shi, Japan, 236-0004
Research Site
Yokohama-shi, Japan, 236-0051
Korea, Republic of
Research Site
Bucheon-si, Korea, Republic of, 14584
Research Site
Daegu, Korea, Republic of, 42415
Research Site
Seoul, Korea, Republic of, 03312
Research Site
Seoul, Korea, Republic of, 04401
Research Site
Seoul, Korea, Republic of, 05030
Research Site
Seoul, Korea, Republic of, 06591
Research Site
Wonju-si, Korea, Republic of, 26426
Netherlands
Research Site
Breda, Netherlands, 4818 CK
Research Site
Eindhoven, Netherlands, 5623 EJ
Research Site
Heerlen, Netherlands, 6419 PC
Research Site
Horn, Netherlands, 6085 NM
Research Site
Nijmegen, Netherlands, 6525 GA
Research Site
Zwolle, Netherlands, 8025 AB
Poland
Research Site
Bydgoszcz, Poland, 85-681
Research Site
Dobre Miasto, Poland, 11-040
Research Site
Gdańsk, Poland, 80-405
Research Site
Gdańsk, Poland
Research Site
Katowice, Poland, 40-081
Research Site
Kościan, Poland, 64-000
Research Site
Kraków, Poland, 31-011
Research Site
Kraków, Poland, 31-209
Research Site
Lublin, Poland, 20-064
Research Site
Lublin, Poland, 20-089
Research Site
Lublin, Poland, 20-468
Research Site
Mrozy, Poland, 05-320
Research Site
Mrągowo, Poland, 11-700
Research Site
Olsztyn, Poland, 10-357
Research Site
Proszowice, Poland, 32-100
Research Site
Radom, Poland, 26-617
Research Site
Ruda Slaska, Poland, 41-709
Research Site
Rzeszów, Poland, 35-241
Research Site
Tarnów, Poland, 33-100
Research Site
Warszawa, Poland, 02-507
Research Site
Wroclaw, Poland, 53-201
Research Site
Wrocław, Poland, 50-220
Research Site
Zakopane, Poland
Research Site
Łódź, Poland, 90-153
Romania
Research Site
Bragadiru, Romania, 077025
Research Site
Brasov, Romania, 500283
Research Site
Bucharest, Romania, 030303
Research Site
Bucharest, Romania, 71593
Research Site
Constanta, Romania, 900002
Research Site
Deva, Romania, 330061
Research Site
Iasi, Romania, 700115
Research Site
Timisoara, Romania, 300310
Russian Federation
Research Site
Chelyabinsk, Russian Federation, 454021
Research Site
Ekaterinburg, Russian Federation, 620039
Research Site
Ekaterinburg, Russian Federation, 620109
Research Site
Ekaterinburg, Russian Federation, 620137
Research Site
Ekaterinburg, Russian Federation, 620219
Research Site
Ivanovo, Russian Federation, 153005
Research Site
Izhevsk, Russian Federation, 426035
Research Site
Kazan, Russian Federation, 420012
Research Site
Kemerovo, Russian Federation, 650000
Research Site
Kemerovo, Russian Federation, 650002
Research Site
Kemerovo, Russian Federation, 650066
Research Site
Moscow, Russian Federation, 109240
Research Site
Moscow, Russian Federation, 117593
Research Site
Moscow, Russian Federation, 121309
Research Site
Moscow, Russian Federation, 127018
Research Site
Moscow, Russian Federation, 127473
Research Site
Nizhny Novgorod, Russian Federation, 603126
Research Site
Novosibirsk, Russian Federation, 630008
Research Site
Novosibirsk, Russian Federation, 630051
Research Site
Novosibirsk, Russian Federation, 630084
Research Site
Penza, Russian Federation, 440067
Research Site
Perm, Russian Federation, 614068
Research Site
Pskov, Russian Federation, 180007
Research Site
Pyatigorsk, Russian Federation, 357500
Research Site
Ryazan, Russian Federation, 390026
Research Site
Saint Petersburg, Russian Federation, 193312
Research Site
Saint Petersburg, Russian Federation, 194354
Research Site
Saint Petersburg, Russian Federation, 197342
Research Site
Saint-Petersburg, Russian Federation, 194354
Research Site
Saint-Petersburg, Russian Federation, 196084
Research Site
Saratov, Russian Federation, 410012
Research Site
Smolensk, Russian Federation, 214019
Research Site
St. Petersburg, Russian Federation, 196247
Research Site
St. Petersburg, Russian Federation, 197089
Research Site
St.Petersburg, Russian Federation, 194354
Research Site
Tomsk, Russian Federation, 634050
Research Site
Tomsk, Russian Federation, 634063
Research Site
Ufa, Russian Federation, 450071
Research Site
Ulyanovsk, Russian Federation, 432009
Research Site
Vladikavkaz, Russian Federation, 362007
Research Site
Vladimir, Russian Federation, 600023
Research Site
Volgograd, Russian Federation, 400001
Research Site
Volgograd, Russian Federation, 400131
South Africa
Research Site
Amanzimtoti, South Africa, 4126
Research Site
Bloemfontein, South Africa, 9301
Research Site
Cape Town, South Africa, 7764
Research Site
Durban, South Africa, 4001
Research Site
Gauteng, South Africa, 2193
Research Site
Middelburg, South Africa, 1055
Spain
Research Site
Alicante, Spain, 03004
Research Site
Badalona(Barcelona), Spain, 08916
Research Site
Barcelona, Spain, 08003
Research Site
Barcelona, Spain, 08025
Research Site
Barcelona, Spain, 08036
Research Site
Madrid, Spain, 28040
Research Site
Málaga, Spain, 29010
Research Site
Palma de Mallorca, Spain, 07010
Research Site
Sabadell (Barcelona), Spain, 08208
Research Site
Santander, Spain, 39008
Research Site
Valencia, Spain, 46015
Switzerland
Research Site
Basel, Switzerland, 4031
Research Site
Biel, Switzerland, 2502
Research Site
Gossau, Switzerland, CH-9202
Research Site
Liestal, Switzerland, CH-4410
Research Site
St. Gallen, Switzerland, 9007
United Kingdom
Research Site
Aberdeen, United Kingdom, AB25 2ZG
Research Site
Birmingham, United Kingdom, B9 5SS
Research Site
Bradford, United Kingdom, BD9 6RJ
Research Site
Cambridge, United Kingdom, CB2 0QQ
Research Site
Chertsey, United Kingdom, KT16 0PZ
Research Site
Edinburgh, United Kingdom, EH16 4TJ
Research Site
Glasgow, United Kingdom, G12 0YN
Research Site
Le3 9qp, United Kingdom
Research Site
London, United Kingdom, SE5 9PJ
Research Site
Manchester, United Kingdom, M23 9QZ
Research Site
Manchester, United Kingdom, M6 8HD
Research Site
Newcastle-Under-Lyme, United Kingdom, ST4 6QG
Research Site
Newcastle-Upon-Tyne, United Kingdom, NE7 7DN
Research Site
Oxford, United Kingdom, OX3 7LE
Research Site
Plymouth, United Kingdom, PL6 8DH
Research Site
Southampton, United Kingdom, SO166YD
Research Site
Wishaw, United Kingdom, ML2 0DP
Research Site
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
AstraZeneca
MedImmune LLC
Investigators
Layout table for investigator information
Principal Investigator: Gerard Criner, MD Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Statistical Analysis Plan  [PDF] April 23, 2018
Study Protocol  [PDF] July 6, 2015


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02138916     History of Changes
Other Study ID Numbers: D3251C00003
First Posted: May 15, 2014    Key Record Dates
Results First Posted: June 13, 2019
Last Update Posted: June 13, 2019
Last Verified: June 2019
Keywords provided by AstraZeneca:
Obstructive Lung Diseases
Chronic Obstructive Pulmonary Disease
Lung Disease
Bronchial Diseases
COPD Exacerbation
Respiratory Tract Diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Benralizumab
Anti-Asthmatic Agents
Respiratory System Agents