Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04631016




Registration number
NCT04631016
Ethics application status
Date submitted
20/10/2020
Date registered
16/11/2020
Date last updated
25/03/2025

Titles & IDs
Public title
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
Scientific title
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4)
Secondary ID [1] 0 0
2020-000571-20
Secondary ID [2] 0 0
D9180C00002
Universal Trial Number (UTN)
Trial acronym
FRONTIER-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Chronic Bronchitis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tozorakimab
Other interventions - Placebo

Experimental: Tozorakimab - Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).

Placebo comparator: Placebo - Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.


Treatment: Drugs: Tozorakimab
Participants will receive SC injection of tozorakimab as stated in arm description.

Other interventions: Placebo
Participants will receive SC injection of placebo as stated in arm description.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic
Assessment method [1] 0 0
The mean change from baseline in Pre-BD FEV1 at Week 12 (tozorakimab - placebo) estimated using a repeated measures mixed effects analysis of covariance measures was estimated. Data available from all visits up to and including Week 12, irrespective of whether the participant discontinued study drug or received reliever therapy was considered. FEV1 was measured by spirometry at clinic.
Timepoint [1] 0 0
Baseline (Day -35 to Day -28) through Week 12
Secondary outcome [1] 0 0
Serum Tozorakimab Concentration
Assessment method [1] 0 0
Serum concentration of tozorakimab collected over time are reported. The lower limit of quantification (LLOQ) for tozorakimab was considered to be 10 µg/L.
Timepoint [1] 0 0
Post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36
Secondary outcome [2] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) to Tozorakimab
Assessment method [2] 0 0
Number of participants with positive ADA to tozorakimab are reported. Treatment-induced ADA positive is defined as ADA negative at baseline and positive at post-baseline assessment. Treatment-boosted ADA positive is defined as ADA positive at baseline and boosted (\>= 4 fold) the pre-existing titre during the study period. Persistent positive is defined as ADA negative at baseline and positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as ADA negative at baseline and at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
Timepoint [2] 0 0
Pre-dose at Study Weeks 0 (baseline) and post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36
Secondary outcome [3] 0 0
Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event
Assessment method [3] 0 0
The COPDCompEx combines exacerbations with events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to one or more of the following: hospitalization, emergency room visit, treatment with systemic corticosteroids (injected and/or oral), or treatment with antibiotics. Diary COPDCompEx events are defined by threshold and slope criteria being met for \>= 2 consecutive days using the following diary and home spirometry variables: overall symptom rating, night-time awakenings due to symptoms, reliever medication use, PEF.
Timepoint [3] 0 0
Baseline (Day -35 to Day -28) through Week 28
Secondary outcome [4] 0 0
Change From Baseline to Week 12 in 4-weekly Mean Evaluating Respiratory Symptoms of COPD (E-RS:COPD) Total Score
Assessment method [4] 0 0
Change from baseline to Week 12 in 4-weekly mean E-RS:COPD total score is reported. The E-RS™:COPD is an 11-item electronic patient reported outcome (ePRO) questionnaires developed to evaluate the severity of respiratory symptoms of COPD including breathlessness (5 items; score range: 0 to 17), cough and sputum (3 items; score range: 0 to 11), and chest symptoms (3 items; score range: 0 to 12). The ePRO was completed every day at home and at site visits. Summation of E-RS:COPD item responses produced a total score ranging from 0 to 40, with higher scores indicating greater severity. The 4-weekly mean will be calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.
Timepoint [4] 0 0
Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Secondary outcome [5] 0 0
Change From Baseline to Week 12 in Mean Breathlessness, Cough and Sputum Scale (BCSS) Score (Over the Previous 4 Weeks)
Assessment method [5] 0 0
Change from baseline to Week 12 in mean BCSS score (over the previous 4 weeks) is reported. The BCSS was a 3-item daily diary that assesses the severity of the 3 symptoms: breathlessness, sputum, and cough, each on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Item scores were summed to yield a total score ranging from 0 to 12; wherein higher total score indicated more severe symptoms. The BCSS was captured each evening via eDiary. The 4-weekly mean BCSS score was calculated as the sum of all non-missing daily scores over the 28-dayevaluation period, divided by the number of non-missing daily scores.
Timepoint [5] 0 0
Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Secondary outcome [6] 0 0
Change From Baseline to Week 12 in Cough Visual Analogue Scale (VAS) Score
Assessment method [6] 0 0
Change from baseline to Week 12 in cough VAS score is reported. Participants were asked to complete a cough severity VAS (100 mm linear scale marked with a horizontal line by the participant, with 0 mm representing ''no cough'' and 100 mm representing "worst cough") that measured subjective assessment by the participant of the prior 24 hrs for severity of cough symptoms. It was completed each evening in the eDiary. The 4-weekly mean cough VAS score was calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.
Timepoint [6] 0 0
Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Secondary outcome [7] 0 0
Change From Baseline to Week 12 in Saint George's Respiratory Questionnaire (SGRQ) Total Score
Assessment method [7] 0 0
Change from baseline to Week 12 in SGRQ total score is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). The total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment.
Timepoint [7] 0 0
Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Secondary outcome [8] 0 0
Percentage of Participants With a Decrease in SGRQ Total Score of >= 4 Points From Baseline to Week 12
Assessment method [8] 0 0
Percentage of participants with a decrease in SGRQ total score of \>= 4 points from baseline to Week 12 is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of individual's respiratory condition. SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). Total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents worst possible health status and 0 indicates best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment. A change of 4 units/points is associated with a minimum clinically important difference.
Timepoint [8] 0 0
Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Secondary outcome [9] 0 0
Change From Baseline to Week 12 in Airwave Oscillometry (AO) Parameters
Assessment method [9] 0 0
Change from baseline to Week 12 in AO parameters including frequency dependence of resistance at 5-20 Hz (R5-R20) and respiratory resistance at 5 Hz (R5; total airway resistance) and 20 Hz (R20; resistance of large airways) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing. AO device uses a vibrating mesh to generate a multifrequency sinusoidal pseudorandom noise (PRN) signal. The AO markers; respiratory resistance at 5 Hz (R5) and 20 Hz (R20) and difference between resistance at 5 and 20Hz (R5-R20; resistance in small airways) are recorded. These markers measure peripheral airway resistance.
Timepoint [9] 0 0
Baseline (Study Day 1) and Week 12
Secondary outcome [10] 0 0
Change From Baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX)
Assessment method [10] 0 0
Change from baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing.
Timepoint [10] 0 0
Baseline (Study Day 1) and Week 12
Secondary outcome [11] 0 0
Ratio to Baseline in Daily, Night-time, and Awake Time Cough Frequency at Week 12
Assessment method [11] 0 0
Ratio to baseline in daily, night-time, and awake time cough frequency at Week 12 is reported. Objective cough frequency was measured using an ambulatory cough monitoring (ACM) which was fitted and worn by the participants for approximately 24 hours after the visits. Daily cough frequency as full average hourly cough of the full duration of recording, night time cough frequency as sleep average hourly cough of the duration of recording at night, and awake time cough frequency as awake average hourly cough of the full duration of recording minus sleep recording will be derived from the recording.
Timepoint [11] 0 0
Baseline (Day -21 to Day -7) and Week 12
Secondary outcome [12] 0 0
Change From Baseline in Pre-BD FEV1 and Post-BD FEV1 Through Week 28 in Participants With Extent of Emphysema < 10%
Assessment method [12] 0 0
Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \< 10% is reported.
Timepoint [12] 0 0
Baseline (Week -5 to -4) through Week 28 post-dose
Secondary outcome [13] 0 0
Change From Baseline in Pre-BD FEV1 and Post-BD FEV1 Through Week 28 in Participants With Extent of Emphysema >= 10%
Assessment method [13] 0 0
Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \>= 10% is reported.
Timepoint [13] 0 0
Baseline (Week -5 to -4) through Week 28 post-dose
Secondary outcome [14] 0 0
Change From Baseline in Pre-BD and Post-BD Forced Vital Capacity (FVC) Through Week 28 in Participants With Extent of Emphysema < 10%
Assessment method [14] 0 0
Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \< 10% is reported.
Timepoint [14] 0 0
Baseline (Week -5 to -4) through Week 28 post-dose
Secondary outcome [15] 0 0
Change From Baseline in Pre-BD and Post-BD FVC Through Week 28 in Participants With Extent of Emphysema >= 10%
Assessment method [15] 0 0
Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \>= 10% is reported.
Timepoint [15] 0 0
Baseline (Week -5 to -4) through Week 28 post-dose
Secondary outcome [16] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)
Assessment method [16] 0 0
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse event of special interest (AESI) are AEs of scientific and medical interest specific to understanding of tozorakimab and requires close monitoring. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Timepoint [16] 0 0
Day 1 through 253 days (maximum observed duration)
Secondary outcome [17] 0 0
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Assessment method [17] 0 0
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (oral or tympanic temperature, diastolic blood pressure, systolic blood pressure, heart \[pulse\] rate, and respiratory rate).
Timepoint [17] 0 0
Day 1 through 253 days (maximum observed duration)
Secondary outcome [18] 0 0
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Assessment method [18] 0 0
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of clinical chemistry, hematology, endocrinology, and urinalysis.
Timepoint [18] 0 0
Day 1 through 253 days (maximum observed duration)
Secondary outcome [19] 0 0
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Assessment method [19] 0 0
Number of participants with abnormal ECGs reported as TEAEs are reported.
Timepoint [19] 0 0
Day 1 through 253 days (maximum observed duration)
Secondary outcome [20] 0 0
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram
Assessment method [20] 0 0
Change from baseline in LVEF as measured by echocardiogram is reported.
Timepoint [20] 0 0
Baseline (Week -3 to -1) through Week 28
Secondary outcome [21] 0 0
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level
Assessment method [21] 0 0
Change in NT-proBNP Level from baseline is reported.
Timepoint [21] 0 0
Baseline (Day -35 to Day -28) through Week 28
Secondary outcome [22] 0 0
Number of Participants With Coronavirus Disease 2019 (COVID-19) Related AEs and SAEs
Assessment method [22] 0 0
The number of participants with COVID-19 related AEs and SAEs are reported.
Timepoint [22] 0 0
Day 1 through 253 days (maximum observed duration)
Secondary outcome [23] 0 0
Number of Participants Seropositive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Assessment method [23] 0 0
Number of participants who were seronegative at baseline and who had positive SARS-Cov-2 serology result at the end of study is reported.
Timepoint [23] 0 0
Baseline (Week 0) through Week 28

Eligibility
Key inclusion criteria
* Provision of informed consent.
* Participant must be 40 to 80 years of age inclusive, at the time of signing the informed consent form (ICF).
* Participants who are current or ex-smokers with a tobacco history of >= 10 pack-years.
* Participants who have a documented history of COPD for at least 1 year.
* Participants who have a post-BD FEV1/FVC < 0.70 and a post-BD FEV1 >= 20% and < 80% predicted normal value at screening. Centralized spirometry will be used for this criteria assessment.
* Participants who have a physician confirmed participant history of chronic bronchitis as defined as presence of cough and sputum on most days for >= 3 months/year in at least the 2 year period immediately prior to study visit 1 (SV1) (Screening).
* Participants who have an average BCSS score of >= 2 in cough and >= 2 in sputum domains assessed over 14 days preceding SV3.
* Participants who have a documented stable regimen of dual therapy or triple therapy for >= 3 months prior to enrolment; there should have been no change in treatment after the previous exacerbation prior to entering into the study. Where dual therapy consists of inhaled corticosteroids (ICS) + long-acting beta 2 agonist (LABA) or LABA + long-acting muscarinic receptor antagonist (LAMA), and triple therapy consists of ICS + LABA + LAMA.
* Participants who have a documented history of >= 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days duration (or 1 injection of depot formulation), or hospitalization for reason of AECOPD in the previous 24 months.
* Body mass index within the range 18 to 40 kg/m^2 (inclusive).
* Female participants of childbearing potential, must have negative pregnancy tests.
* Male and female participants must follow protocol contraceptive guidance.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with a positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening. Participants with mild or asymptomatic disease could be rescreened.
* Participants with a significant coronavirus disease 2019 (COVID-19) illness within 6 months of enrolment.
* As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason which in the investigator's opinion makes it undesirable for the participant to participate in the study.
* Current or past diagnosis of asthma which persisted beyond age of 25 years.
* Clinically important pulmonary disease other than COPD, radiological findings, and/or laboratory findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms.
* Increased pre-BD FEV1 at randomization visit (SV3) compared to Screening SV1 of >= 400 mL or >= 25% of SV1 FEV1.
* Any other clinically relevant abnormal findings on physical examination, laboratory testing; or chest CT scan, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study.

Chest CT scan findings requiring further investigation or repeat CT surveillance before SV14.

* A family history of heart failure.
* A LVEF < 45% measured by echocardiogram.
* History of a clinically significant infection (viral, bacterial, or fungal) within 4 weeks.
* History of, or a reason to believe a participant has a history of, drug or alcohol abuse within the past 2 years prior to screening.
* Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
* Evidence of active or untreated latent tuberculosis (TB).
* Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.
* Participants currently receiving background therapy that is not approved by regulatory authorities in the country of study for COPD are not eligible for the study.
* History of treatment with cardiotoxic medications (eg, as part of cancer therapy) including thiazolidinedione's.
* Treatment with broad spectrum antibiotic within 4 weeks prior to randomization (Day 1).
* Receiving any of the prohibited concomitant medications as specified in the clinical study protocol (CSP).
* Inability to perform technically acceptable spirometry.

Additional inclusion and exclusion criteria's applies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/11/2023
Sample size
Target
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Nedlands
Recruitment hospital [2] 0 0
Research Site - South Brisbane
Recruitment hospital [3] 0 0
Research Site - Spearwood
Recruitment hospital [4] 0 0
Research Site - Tarragindi
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
6163 - Spearwood
Recruitment postcode(s) [4] 0 0
4121 - Tarragindi
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
Newfoundland and Labrador
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Czechia
State/province [17] 0 0
Brno
Country [18] 0 0
Czechia
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czechia
State/province [19] 0 0
Pisek
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha 4
Country [21] 0 0
Czechia
State/province [21] 0 0
Rokycany
Country [22] 0 0
Denmark
State/province [22] 0 0
Hvidovre
Country [23] 0 0
Denmark
State/province [23] 0 0
København NV
Country [24] 0 0
Denmark
State/province [24] 0 0
Naestved
Country [25] 0 0
Denmark
State/province [25] 0 0
Odense C
Country [26] 0 0
Denmark
State/province [26] 0 0
Ålborg
Country [27] 0 0
Germany
State/province [27] 0 0
Bamberg
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Darmstadt
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Leipzig
Country [32] 0 0
Germany
State/province [32] 0 0
Mainz
Country [33] 0 0
Germany
State/province [33] 0 0
Marburg
Country [34] 0 0
Hungary
State/province [34] 0 0
Balassagyarmat
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Hungary
State/province [36] 0 0
Debrecen
Country [37] 0 0
Hungary
State/province [37] 0 0
Edelény
Country [38] 0 0
Hungary
State/province [38] 0 0
Gödöllo
Country [39] 0 0
Hungary
State/province [39] 0 0
Hajdúnánás
Country [40] 0 0
Hungary
State/province [40] 0 0
Pécs
Country [41] 0 0
Israel
State/province [41] 0 0
Ashkelon
Country [42] 0 0
Israel
State/province [42] 0 0
Jerusalem
Country [43] 0 0
Israel
State/province [43] 0 0
Rehovot
Country [44] 0 0
Netherlands
State/province [44] 0 0
Eindhoven
Country [45] 0 0
Netherlands
State/province [45] 0 0
Rotterdam
Country [46] 0 0
Netherlands
State/province [46] 0 0
Zutphen
Country [47] 0 0
New Zealand
State/province [47] 0 0
Auckland
Country [48] 0 0
New Zealand
State/province [48] 0 0
Christchurch
Country [49] 0 0
New Zealand
State/province [49] 0 0
Tauranga
Country [50] 0 0
New Zealand
State/province [50] 0 0
Wellington
Country [51] 0 0
Poland
State/province [51] 0 0
Bialystok
Country [52] 0 0
Poland
State/province [52] 0 0
Bydgoszcz
Country [53] 0 0
Poland
State/province [53] 0 0
Katowice
Country [54] 0 0
Poland
State/province [54] 0 0
Krakow
Country [55] 0 0
Poland
State/province [55] 0 0
Poznan
Country [56] 0 0
Poland
State/province [56] 0 0
Tarnów
Country [57] 0 0
Poland
State/province [57] 0 0
Wroclaw
Country [58] 0 0
South Africa
State/province [58] 0 0
Cape Town
Country [59] 0 0
South Africa
State/province [59] 0 0
Durban
Country [60] 0 0
South Africa
State/province [60] 0 0
Johannesburg
Country [61] 0 0
South Africa
State/province [61] 0 0
Tygervalley
Country [62] 0 0
Spain
State/province [62] 0 0
Alzira
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Málaga
Country [65] 0 0
Spain
State/province [65] 0 0
Mérida
Country [66] 0 0
Spain
State/province [66] 0 0
Salamanca
Country [67] 0 0
Spain
State/province [67] 0 0
Santander
Country [68] 0 0
Spain
State/province [68] 0 0
Zaragoza
Country [69] 0 0
Taiwan
State/province [69] 0 0
Kaohsiung
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei City
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taoyuan City
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Bradford
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Bristol
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Edinburgh
Country [75] 0 0
United Kingdom
State/province [75] 0 0
London
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Newcastle-Upon-Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04631016