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

  • STATUS
    Recruiting
  • End date
    Apr 6, 2024
  • participants needed
    120
  • sponsor
    Genentech, Inc.
Updated on 21 October 2022

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.

Details
Condition Chronic Obstructive Pulmonary Disease
Treatment Azithromycin, HP xenon (¹²⁹XE)
Clinical Study IdentifierNCT04353661
SponsorGenentech, Inc.
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
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