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

Overview

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.

Full Title of Study: “¹²⁹XE MRI Assessment Of Disease Progression In Patients With Chronic Obstructive Pulmonary Disease Treated With Standard-of-Care Medications With Or Without Daily Open-Label Azithromycin Treatment To Prevent Acute Exacerbation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2022

Interventions

  • Drug: Azithromycin
    • Azithromycin will be administered orally.
  • Other: HP xenon (¹²⁹XE)
    • HP xenon (¹²⁹XE) will be administered at an approximate dose of 1 L or up to 25% of the Participant’s total lung capacity followed by a breath hold of up to 15 seconds.

Arms, Groups and Cohorts

  • Experimental: Arm A Open-label: azithromycin + SOC therapy
    • Participants will receive azithromycin and SOC theraphy for 52 weeks.
  • Active Comparator: Arm A Open-label: SOC therapy
    • Participants will receive SOC theraphy for 52 weeks.
  • Active Comparator: Arm B Observational: SOC therapy
    • Participants will receive SOC theraphy for 52 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in ¹²⁹XE MRI VDP from Baseline to 24 weeks
    • Time Frame: Baseline up to Week 24
  • Rate of Moderate/Severe AEs
    • Time Frame: Baseline up to Week 48
  • Rate of Moderate/Severe Exacerbation
    • Time Frame: Baseline up to Week 48
    • A moderate COPD exacerbation is defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that lead to treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation is defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that lead to hospitalization or death.

Secondary Measures

  • Absolute Change in Pre-bronchodilator FEV-1 (Liters)
    • Time Frame: Baseline up to Week 24
  • Absolute Change in Pre-bronchodilator FEV-1 (Liters)
    • Time Frame: Baseline up to Week 48
  • Number of Participant with Adverse Events With Severity Determined According To The World Health Organization (WHO) Toxicity Scale
    • Time Frame: Baseline up to 24 months

Participating in This Clinical Trial

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
  • GOLD 2-4 with a history of ≥ 2 moderate/severe exacerbations in the last 12 months (limited to Cohort A)
  • GOLD 1 with a history of ≥ 1 moderate/severe exacerbations in the last 12 months (limited to Cohort B)
  • 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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Genetech
  • Overall Contact(s)
    • Reference Study ID GE42063 Number: www.roche.com/about_roche/roche_worldwide.htm, 888-662-6728 (U.S.), global-roche-genentech-trials@gene.com

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