A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications

NCT ID: NCT04353661

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2023-06-29

Brief Summary

This study will test whether daily use of azithromycin will reduce the rate of exacerbations and improve lung ventilation and perfusion assessed by XE-MRI. The sensitivity of XE-MRI to detect COPD progression will be compared with standard clinical assessment measures including standard lung function tests, 6 minute walk test, and patient reported quality of life.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A Open-label: azithromycin + SOC therapy

Participants will receive azithromycin and SOC theraphy for 52 weeks.

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

Azithromycin will be administered orally.

HP xenon (¹²⁹XE)

Intervention Type: OTHER

HP xenon (¹²⁹XE) will be administered at specified timepoints and the total dose bag volume should target 20% of the patient's forced vital capacity followed by a breath hold of up to 15 seconds

Arm A Open-label: SOC therapy

Participants will receive SOC theraphy for 52 weeks.

Group Type: ACTIVE_COMPARATOR

HP xenon (¹²⁹XE)

Intervention Type: OTHER

HP xenon (¹²⁹XE) will be administered at specified timepoints and the total dose bag volume should target 20% of the patient's forced vital capacity followed by a breath hold of up to 15 seconds

Arm B Observational: SOC therapy

Participants will receive SOC theraphy for 52 weeks.

Group Type: ACTIVE_COMPARATOR

HP xenon (¹²⁹XE)

Intervention Type: OTHER

HP xenon (¹²⁹XE) will be administered at specified timepoints and the total dose bag volume should target 20% of the patient's forced vital capacity followed by a breath hold of up to 15 seconds

Interventions

Azithromycin

Azithromycin will be administered orally.

Intervention Type: DRUG

HP xenon (¹²⁹XE)

HP xenon (¹²⁹XE) will be administered at specified timepoints and the total dose bag volume should target 20% of the patient's forced vital capacity followed by a breath hold of up to 15 seconds

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Current or former smokers with years ≥ 10 pack years
• mMRC dyspnea score > 1
• Post-bronchodilator FEV-1/forced vital capacity (FVC) <0.70 at Visit 1 or Visit 2
• Cohort A: GOLD Stage 2-4 COPD with a history of ≥ 2 moderate/severe exacerbations within a 12-month period in the 24 months prior to screening
• Cohort B: GOLD Stage 1 COPD with a history of ≥1 moderate/severe exacerbations within a 12-month period in the 24 months prior to screening
• Receiving SOC background drug therapy as per GOLD or British Thoracic Society (BTS) guidance for COPD for 12 weeks prior to screening Visit 1
• On an eligible bronchodilator medication (LABA ± LAMA) ± ICS therapy for ≥12 weeks prior to Visit 1
• Chest X-ray or CT scan within 6 months prior to Visit 1, or during the screening period (prior to Visit 2), that confirms the absence of clinically significant lung disease besides COPD
• Use of contraceptive measures

Exclusion Criteria

• Diagnosis of significant respiratory disease other than COPD
• Comorbid conditions that may interfere with the evaluation of an investigational medical product
• Known sensitivity or allergy to azithromycin
• A COPD exacerbation and or pneumonia within 4 weeks prior to Visit 1
• Use of systemic corticosteroids within 4 weeks (oral or intravenous) or within 12 weeks (intramuscular IM) prior to screening Visit 1
• MRI is contraindicated
• Any known arrhythmia, bradycardia or severe cardiac insufficiency
• Participant can not hold breath for 15 seconds
• Participant does not fit in the ¹²⁹XE vest coil used for MRI
• Pregnant, lactating, or intending to become pregnant during the study or within 4 weeks after the last dose of the investigational medical product
• History or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
• For participants in Cohort A: Known significant hearing impairment as indicated by a score of ≥ 26 on the Hearing Handicap Inventory in the Elderly-Screening Questionnaire or as determined by the investigator
• History of Clostridium difficile (C. difficile) diarrhea Clinically significant ECG changes, which in the opinion of investigator warrants further investigation or with a QTc interval > 450 ms

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genetech

Locations

Duke Asthma Allergy and Airway Center

Durham, North Carolina, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

Canada; United Kingdom; United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GE42063

Identifier Type: -

Identifier Source: org_study_id