An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO inhibitor) vs placebo in the treatment of moderate to severe COPD. - CRESCENDO

Study identifier:D6582C00001

ClinicalTrials.gov identifier:NCT05492877

EudraCT identifier:2022-002441-18

CTIS identifier:N/A

Study Complete

Official Title

A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 weeks, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

Study drug

Mitiperstat (AZD4831)

Sex

All

Actual Enrollment

381

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 14 Nov 2022

Primary Completion Date: 12 Aug 2024

Study Completion Date: 12 Aug 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Bradford, United Kingdom, BD9 6RJ

Location

Research Site

Groningen, Netherlands, 9713 GH

Location

Research Site

Szczecin, Poland, 70-111

Location

Research Site

Wakefield, United Kingdom, WF1 4DG

Location

Research Site

Glasgow, United Kingdom, G12 0YN

Location

Research Site

Ksawerów, Poland, 95-054

Location

Research Site

Kraków, Poland, 31-011

Location

Research Site

Karczew, Poland, 05-480

Arms	Assigned Interventions
Placebo Comparator: Placebo Approximately 203 participants will be randomised to receive placebo.	Other: Placebo Oral dosage, once daily. Other Name: N/A
Experimental: Mitiperstat (AZD4831) Approximately 203 participants will be randomised to receive mitiperstat (AZD4831).	Drug: Mitiperstat (AZD4831) Oral dosage, once daily. Other Name: N/A

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 101 centers in 14 countries (Argentina, Bulgaria, Canada, Denmark, Germany, Italy, Mexico, Netherlands, Poland, South Africa, Spain, Turkey, UK and USA).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 381 participants were randomized and received at least one dose of study drug.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Participant Flow: Overall Study

	Mitiperstat	Placebo
STARTED	189	192
Treated	189	192
COMPLETED	165	170
NOT COMPLETED	24	22
Adverse Event	11	7
Death	1	0
Lost to Follow-up	1	1
Physician Decision	1	2
Protocol Violation	1	1
Withdrawal by Subject	3	7
Reason not specified	6	4

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Baseline Measures

	Mitiperstat	Placebo	Total
Number of Participants [units: Participants]	189	192	381
Age Continuous [units: Years] Mean ± Standard Deviation	66.2 ± 6.65	65.7 ± 7.03	66 ± 6.84
Sex: Female, Male [units: ]
Female	77	74	151
Male	112	118	230
Ethnicity (NIH/OMB) [units: ]
Hispanic or Latino	26	27	53
Not Hispanic or Latino	163	165	328
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: ]
American Indian or Alaska Native	1	1	2
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	1	3
White	182	183	365
More than one race	0	0	0
Unknown or Not Reported	3	6	9

Outcome Measures

1. Primary Outcome Measure: To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event in patients with moderate to severe COPD. [ Time Frame: From baseline to up to 24 weeks ]

Measure Type	Primary
Measure Name	To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event in patients with moderate to severe COPD.
Measure Description	COPDCompEx is a composite endpoint of exacerbations and 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. COPDCompEx also includes patient withdrawals for treatment failure.
Time Frame	From baseline to up to 24 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Measured Values

	Mitiperstat	Placebo
Number of Participants Analyzed [units:participants]	189	192
To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event in patients with moderate to severe COPD. [units: Participants]	125	125

Statistical Analysis 1 for To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event in patients with moderate to severe COPD.

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.599
Hazard Ratio (HR)^[5]	1.071
90% Confidence Interval	( 0.869 to 1.320 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD [ Time Frame: At week 12 ]

Measure Type	Secondary
Measure Name	To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD
Measure Description	Measurement of Time to Reach Maximum Plasma Concentration (Tmax) at pre-randomisation (baseline visit) and week 12.
Time Frame	At week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK set included all participants who had received mitiperstat and had evaluable PK data for mitiperstat, with no important protocol deviations that were thought to have impacted the analysis of the PK data.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.

Measured Values

	Mitiperstat
Number of Participants Analyzed [units:participants]	36
To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD [units: hours] Median (Full Range)	1.292 (0.42 to 2.92)

No statistical analysis provided for To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD

3. Secondary Outcome Measure: To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD. [ Time Frame: At week 12 ]

Measure Type	Secondary
Measure Name	To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD.
Measure Description	Measurement of Maximum Plasma Concentration (Cmax) at pre-randomisation (baseline visit) and week 12.
Time Frame	At week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK set included all participants who had received mitiperstat and had evaluable PK data for mitiperstat, with no important protocol deviations that were thought to have impacted the analysis of the PK data.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.

Measured Values

	Mitiperstat
Number of Participants Analyzed [units:participants]	36
To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD. [units: nmol/L] Geometric Mean (Geometric Coefficient of Variation)	38.786 (39.5%)

No statistical analysis provided for To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD.

4. Secondary Outcome Measure: To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation. [ Time Frame: From baseline to up to week 24 ]

Measure Type	Secondary
Measure Name	To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation.
Measure Description	A COPD exacerbation was considered moderate if it required treatment with systemic corticosteroids and/or antibiotics for at least 3 days or resulted in emergency room visit< 24 hours requiring intensive treatment; and did not result in hospitalization or death. A COPD exacerbation was considered severe if it resulted in hospitalization (defined as an inpatient admission ≥ 24 hours in the hospital, an observation area, the emergency department, or other equivalent healthcare facility depending on the country and healthcare system) or death due to COPD.
Time Frame	From baseline to up to week 24
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Measured Values

	Mitiperstat	Placebo
Number of Participants Analyzed [units:participants]	189	192
To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation. [units: Participants]	53	44

Statistical Analysis 1 for To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation.

Groups^[1]	All groups
Method^[3]	Regression, Cox
Hazard Ratio (HR)^[5]	1.234
90% Confidence Interval	( 0.882 to 1.726 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) in patients with moderate to severe COPD. [ Time Frame: From baseline to week 12 ]

Measure Type	Secondary
Measure Name	To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) in patients with moderate to severe COPD.
Measure Description	The mean change from baseline in Post-BD FEV1 at Week 12 was estimated using a repeated measures mixed effects analysis of covariance. Only subjects with non-missing covariates are included in the analysis. FEV1 was measured by spirometry at clinic.
Time Frame	From baseline to week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Measured Values

	Mitiperstat	Placebo
Number of Participants Analyzed [units:participants]	130	136
To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) in patients with moderate to severe COPD. [units: Litre] Least Squares Mean (Standard Error)	-0.049 (0.0178)	-0.031 (0.0175)

No statistical analysis provided for To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) in patients with moderate to severe COPD.

6. Secondary Outcome Measure: To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]

Measure Type	Secondary
Measure Name	To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.
Measure Description	Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) which is a 14-item ePRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. It has a theoretical range of 0 to 100, with higher values indicating a more severe condition. The EXACT will be performed at on-site visits using the e-Diary.
Time Frame	From baseline to week 12 and week 24
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Measured Values

	Mitiperstat	Placebo
Number of Participants Analyzed [units:participants]	189	192
To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD. [units: Units on a scale] Least Squares Mean (Standard Error)
Week 12	0.1 (0.97)	-2.4 (0.95)
Week 24	-1.9 (1.32)	-3.7 (1.36)

No statistical analysis provided for To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.

7. Secondary Outcome Measure: To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]

Measure Type	Secondary
Measure Name	To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.
Measure Description	Change from baseline to Week 12 and week 24 in mean Breathlessness, Cough and Sputum Scale (BCSS) score 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.
Time Frame	From baseline to week 12 and week 24
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Measured Values

	Mitiperstat	Placebo
Number of Participants Analyzed [units:participants]	189	192
To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD. [units: Units on a scale] Least Squares Mean (Standard Error)
Week 12	0.16 (0.130)	0.15 (0.127)
Week 24	0.11 (0.166)	-0.17 (0.172)

No statistical analysis provided for To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.

8. Secondary Outcome Measure: To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]

Measure Type	Secondary
Measure Name	To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD.
Measure Description	Change from baseline to Week 12 and week 24 in cough Visual Analogue Scale (VAS) score is reported. Participants were asked to complete a cough severity VAS (100-point linear scale marked with a horizontal line by the participant, with 0 representing ''no cough'' and 100 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.
Time Frame	From baseline to week 12 and week 24
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Measured Values

	Mitiperstat	Placebo
Number of Participants Analyzed [units:participants]	189	192
To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD. [units: Units on a scale] Least Squares Mean (Standard Error)
Week 12	-1.25 (1.183)	-3.05 (1.160)
Week 24	-2.64 (1.540)	-3.48 (1.562)

No statistical analysis provided for To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD.

9. Secondary Outcome Measure: Change from baseline to Week 12 in total COPD Assessment Test (CAT) [ Time Frame: From baseline to Week 12 ]

Measure Type	Secondary
Measure Name	Change from baseline to Week 12 in total COPD Assessment Test (CAT)
Measure Description	COPD Assessment Test (CAT) is designed to measure how COPD impacts on a patient’s daily life and how this might change over time. It consists of 8 questions that ask the patient to rate items relating to symptoms and impact on quality of life (such as normal activity and sleep). Each question is performed on a 5-point Likert scale from 0 (no symptoms/no impact) to 5 (severe symptoms/impact). The CAT will be completed by participants at on-site visits using the e-Diary.
Time Frame	From baseline to Week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Measured Values

	Mitiperstat	Placebo
Number of Participants Analyzed [units:participants]	134	134
Change from baseline to Week 12 in total COPD Assessment Test (CAT) [units: Units on a scale] Least Squares Mean (Standard Error)	-1.2 (0.62)	-1.2 (0.64)

No statistical analysis provided for Change from baseline to Week 12 in total COPD Assessment Test (CAT)

Serious Adverse Events

Time Frame	From treatment start to the end of the follow-up period
Additional Description	No text entered.

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Serious Adverse Events

Mitiperstat

Placebo

Total, serious adverse events

# participants affected / at risk

23/189 (12.17%)

13/192 (6.77%)

Infections and infestations

Tuberculosis¹,^†

# participants affected / at risk

0/189 (0.00%)

1/192 (0.52%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Carcinoid tumour pulmonary¹,^†

# participants affected / at risk

0/189 (0.00%)

1/192 (0.52%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma¹,^†

# participants affected / at risk

1/189 (0.53%)

1/192 (0.52%)

# events

Nervous system disorders

Carotid artery thrombosis¹,^†

# participants affected / at risk

1/189 (0.53%)

0/192 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

14/189 (7.41%)

5/192 (2.60%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

0/189 (0.00%)

1/192 (0.52%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

0/189 (0.00%)

2/192 (1.04%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary mass¹,^†

# participants affected / at risk

0/189 (0.00%)

1/192 (0.52%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory failure¹,^†

# participants affected / at risk

1/189 (0.53%)

0/192 (0.00%)

# events

Vascular disorders

Aortic aneurysm¹,^†

# participants affected / at risk

1/189 (0.53%)

0/192 (0.00%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

1/189 (0.53%)

0/192 (0.00%)

# events

Cardiac disorders

Cardiac failure acute¹,^†

# participants affected / at risk

1/189 (0.53%)

0/192 (0.00%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/189 (0.53%)

0/192 (0.00%)

# events

Hepatobiliary disorders

Cholecystitis acute¹,^†

# participants affected / at risk

1/189 (0.53%)

0/192 (0.00%)

# events

Hepatobiliary disorders

Portal hypertension¹,^†

# participants affected / at risk

1/189 (0.53%)

0/192 (0.00%)

# events

Infections and infestations

Infective exacerbation of chronic obstructive airways disease¹,^†

# participants affected / at risk

0/189 (0.00%)

1/192 (0.52%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

5/189 (2.65%)

3/192 (1.56%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 27.0

Other Adverse Events

Time Frame	From treatment start to the end of the follow-up period
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Mitiperstat	Participants received an oral tablet of mitiperstat 5mg once daily.
Placebo	Participants receive an oral tablet of placebo matched to mitiperstat once daily.

Other Adverse Events

Mitiperstat

Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

53/189 (28.04%)

45/192 (23.44%)

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

45/189 (23.81%)

36/192 (18.75%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

11/189 (5.82%)

12/192 (6.25%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 27.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: AstraZeneca has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca Clinical Study Information Center
Phone	+1-877-240-9479
E-mail:	[email protected]

Documents available

D6582C00001 CSR Synopsis
Download
D6582C00001 CSP Redacted
Download
D6582C00001 SAP
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

D6582C00001 CSR Synopsis

D6582C00001 CSP Redacted

D6582C00001 SAP

Trial Results Summaries