Back to resultsA Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
HP xenon (¹²⁹XE)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
- University of Iowa
- Duke Asthma Allergy and Airway Center
- University of Virginia Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Arm A Open-label: azithromycin + SOC therapy
Arm A Open-label: SOC therapy
Arm B Observational: SOC therapy
Arm Description
Participants will receive azithromycin and SOC theraphy for 52 weeks.
Participants will receive SOC theraphy for 52 weeks.
Participants will receive SOC theraphy for 52 weeks.
Outcomes
Primary Outcome Measures
Change in ¹²⁹XE MRI VDP from Baseline to 24 weeks
Rate of Moderate/Severe AEs
Rate of Moderate/Severe Exacerbation
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 Outcome Measures
Absolute Change in Pre-bronchodilator FEV-1 (Liters)
Absolute Change in Pre-bronchodilator FEV-1 (Liters)
Number of Participant with Adverse Events With Severity Determined According To The World Health Organization (WHO) Toxicity Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04353661
Brief Title
A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications
Official Title
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
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated by Sponsor due to patient recruitment challenges.
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
June 29, 2023 (Actual)
Study Completion Date
June 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a multicenter, open-label, parallel group, randomized controlled trial (RCT).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A Open-label: azithromycin + SOC therapy
Arm Type
Experimental
Arm Description
Participants will receive azithromycin and SOC theraphy for 52 weeks.
Arm Title
Arm A Open-label: SOC therapy
Arm Type
Active Comparator
Arm Description
Participants will receive SOC theraphy for 52 weeks.
Arm Title
Arm B Observational: SOC therapy
Arm Type
Active Comparator
Arm Description
Participants will receive SOC theraphy for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin will be administered orally.
Intervention Type
Other
Intervention Name(s)
HP xenon (¹²⁹XE)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in ¹²⁹XE MRI VDP from Baseline to 24 weeks
Time Frame
Baseline up to Week 24
Title
Rate of Moderate/Severe AEs
Time Frame
Baseline up to Week 48
Title
Rate of Moderate/Severe Exacerbation
Description
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.
Time Frame
Baseline up to Week 48
Secondary Outcome Measure Information:
Title
Absolute Change in Pre-bronchodilator FEV-1 (Liters)
Time Frame
Baseline up to Week 24
Title
Absolute Change in Pre-bronchodilator FEV-1 (Liters)
Time Frame
Baseline up to Week 48
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genetech
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Duke Asthma Allergy and Airway Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-2671
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications
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