An Efficacy and Safety Study of AZD4831 (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 26.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-002441-18-DK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-22
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

1. Confirmed primary diagnosis of moderate to severe COPD as per FEV1/FVC < 0.7, and post-BD FEV1 = 25% predicted)
2. Current or ex-smokers with a tobacco history of = 10 pack-years
3. High risk of exacerbations as defined by any one of the following:
(a) 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 hospitalisation for reason of AECOPD in the 24 months prior to screening or
(b) Frequent productive cough, defined as a positive response to both of the following questions:
•Over the past 3 months, I have coughed at least several days a week
•Over the past 3 months, I have brought up phlegm (sputum) at least several days a week, or
(c) Post-BD FEV1 < 50% predicted.
4. Clinically stable and free from an exacerbation of COPD for 1 month prior to SV1 (screening) and prior to Day 1.
5. Participants who are at least 70% compliant with each of the following: morning e-Diary, evening e-Diary, and PEF measurements during the 14 days preceding SV3 based on the e-Diary.
6. Participants who have a documented stable regimen of triple therapy or dual therapy for = 3 months prior to enrolment. Triple therapy may consist of an appropriate combination of ICS + LABA + LAMA. Dual therapy consists of either inhaled ICS/LABA or LABA + LAMA where the treating physician deems the participant unsuitable for ICS (eg, blood eosinophil count = 100 cells/µL on 2 separate occasions, or on the basis of previous or perceived risk of significant AEs from ICS-based therapy, such as previous episodes of pneumonia or significant oral candidiasis).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 203
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 203

Exclusion Criteria

1. Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years
2. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin and stable prostate cancer)
3. Evidence of untreated active TB:
Participants currently receiving treatment for active TB may be considered after completion of an appropriate course of therapy.
4. Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.
5. Current diagnosis of hyperthyroidism, uncontrolled hypothyroidism (including but not limited to TSH = 10 mIU/L), or any clinically significant thyroid disease.
6. Participant who is going to start or finish intensive COPD rehabilitation program at anytime during study period. Participants can be recruited immediately following the completion of their COPD rehabilitation program.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified