Trial · NCT04631016

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis

NCT04631016, Phase 2, Completed, AstraZeneca; results first posted 2025-02-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis. Trials, record NCT04631016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04631016

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
NCT number: NCT04631016
Status: Completed
Phases: Phase 2
Enrollment: 137 participants, actual
Lead sponsor: AstraZeneca
Conditions: Chronic Obstructive Pulmonary Disease (COPD), Chronic Bronchitis
Interventions: Tozorakimab, Placebo
First posted: 2020-11-16
Last updated: 2025-02-27
Other registries' IDs: eudract:2020-000571-20
Results first posted: 2025-02-27

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic	Baseline (Day -35 to Day -28) through Week 12	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.
Secondary	Serum Tozorakimab Concentration	Post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36	Serum concentration of tozorakimab collected over time are reported. The lower limit of quantification (LLOQ) for tozorakimab was considered to be 10 μg/L.
Secondary	Number of Participants With Positive Anti-drug Antibodies (ADA) to Tozorakimab	Pre-dose at Study Weeks 0 (baseline) and post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36	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.
Secondary	Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event	Baseline (Day -35 to Day -28) through Week 28	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.
Secondary	Change From Baseline to Week 12 in 4-weekly Mean Evaluating Respiratory Symptoms of COPD (E-RS:COPD) Total Score	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	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.
Secondary	Change From Baseline to Week 12 in Mean Breathlessness, Cough and Sputum Scale (BCSS) Score (Over the Previous 4 Weeks)	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	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.
Secondary	Change From Baseline to Week 12 in Cough Visual Analogue Scale (VAS) Score	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	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.
Secondary	Change From Baseline to Week 12 in Saint George's Respiratory Questionnaire (SGRQ) Total Score	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	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.
Secondary	Percentage of Participants With a Decrease in SGRQ Total Score of >= 4 Points From Baseline to Week 12	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	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.
Secondary	Change From Baseline to Week 12 in Airwave Oscillometry (AO) Parameters	Baseline (Study Day 1) and Week 12	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.

1 to 10 of 25Source ClinicalTrials.gov

See all 25 registered outcomes

Outcomes25

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic	Baseline (Day -35 to Day -28) through Week 12	Intent-to-treat (ITT) population included all participants who received any study drug and were analyzed according to the treatment they actually received.	Litre	LEAST_SQUARES_MEAN
SECONDARY	Serum Tozorakimab Concentration	Post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36	Pharmacokinetic (PK) evaluable population included participants who received at least 1 dose of tozorakimab and had at least 1 detectable post-treatment sample available. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Number analyzed (n) denotes those participants who had adequate PK sample available at the specified time point.	μg/L	MEAN
SECONDARY	Number of Participants With Positive Anti-drug Antibodies (ADA) to Tozorakimab	Pre-dose at Study Weeks 0 (baseline) and post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36	As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who had at least one post-baseline ADA assessment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event	Baseline (Day -35 to Day -28) through Week 28	ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline to Week 12 in 4-weekly Mean Evaluating Respiratory Symptoms of COPD (E-RS:COPD) Total Score	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 in Mean Breathlessness, Cough and Sputum Scale (BCSS) Score (Over the Previous 4 Weeks)	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 in Cough Visual Analogue Scale (VAS) Score	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received.	mm	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 in Saint George's Respiratory Questionnaire (SGRQ) Total Score	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 12.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With a Decrease in SGRQ Total Score of >= 4 Points From Baseline to Week 12	Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12	ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 12.	Percentage of Participants	NUMBER
SECONDARY	Change From Baseline to Week 12 in Airwave Oscillometry (AO) Parameters	Baseline (Study Day 1) and Week 12	ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 12.	kPa*s/L	LEAST_SQUARES_MEAN

1 to 10 of 25Source ClinicalTrials.gov

See all 25 outcomes

Results by group108

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic	Tozorakimab		0.019	Standard Error 0.026	Litre
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic	Placebo		-0.005	Standard Error 0.025	Litre
Serum Tozorakimab Concentration	Tozorakimab	Week 2	24604.70	Standard Deviation 43934.55	μg/L
Serum Tozorakimab Concentration	Tozorakimab	Week 4	8041.59	Standard Deviation 22355.66	μg/L
Serum Tozorakimab Concentration	Tozorakimab	Week 12	7548.78	Standard Deviation 6416.68	μg/L
Serum Tozorakimab Concentration	Tozorakimab	Week 20	10789.81	Standard Deviation 31903.70	μg/L
Serum Tozorakimab Concentration	Tozorakimab	Week 24	6410.05	Standard Deviation 4123.46	μg/L
Serum Tozorakimab Concentration	Tozorakimab	Week 28	7289.36	Standard Deviation 5331.35	μg/L
Serum Tozorakimab Concentration	Tozorakimab	Week 32	1483.19	Standard Deviation 1779.88	μg/L
Serum Tozorakimab Concentration	Tozorakimab	Week 36	420.13	Standard Deviation 701.12	μg/L

1 to 10 of 108Source ClinicalTrials.gov

See all 108 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tozorakimab	69
Overall Study	STARTED	Placebo	68
Overall Study	Treated	Tozorakimab	67
Overall Study	Treated	Placebo	68
Overall Study	COMPLETED	Tozorakimab	58
Overall Study	COMPLETED	Placebo	63
Overall Study	NOT COMPLETED	Tozorakimab	11
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Tozorakimab	8	67	10
other	Headache	Nervous system disorders	Placebo	3	68	3
other	Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Tozorakimab	26	67	53
other	Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Placebo	27	68	56
other	Injection site erythema	General disorders	Tozorakimab	10	67	25
other	Injection site erythema	General disorders	Placebo	0	68	0
other	Covid-19	Infections and infestations	Tozorakimab	14	67	15
other	Covid-19	Infections and infestations	Placebo	14	68	14
other	Nasopharyngitis	Infections and infestations	Tozorakimab	3	67	4
other	Nasopharyngitis	Infections and infestations	Placebo	7	68	12

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tozorakimab	0	67
Total, all-cause mortality	Placebo	0	68
Total, other adverse events	Tozorakimab	40	67
Total, other adverse events	Placebo	39	68
Total, serious adverse events	Tozorakimab	14	67
Total, serious adverse events	Placebo	9	68

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tozorakimab vs Placebo: Number of Participants Seropositive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)	Trial comparisons
Tozorakimab vs Placebo: Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs	Trial comparisons
Tozorakimab vs Placebo: Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event	Trial comparisons
Tozorakimab vs Placebo: deaths from any cause	Trial comparisons
Tozorakimab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04631016

GET https://conductscience.org/api/trials/v1/NCT04631016/registered?page=2

API reference For AI assistants