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

• Status: Recruiting
• Trial end date: 2023-10-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Azithromycin; Xenon

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 or assessed hearing impairment using formal audiometry testing

• 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