Status:
TERMINATED
A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications
Lead Sponsor:
Genentech, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04353661
Start Date
November 16 2021
End Date
June 29 2023
Last Update
December 24 2024
Active Locations (2)
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1
Duke Asthma Allergy and Airway Center
Durham, North Carolina, United States, 27705-2671
2
University of Virginia Health System
Charlottesville, Virginia, United States, 22908