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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04353661
• Other study ID #: GE42063
• Status: Terminated
• Phase: Phase 2
• Start date: November 16, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: July 2023
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 ¹²?XE 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Disease Progression
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Azithromycin
Azithromycin will be administered orally.

Other:
• HP xenon (¹²?XE)
HP xenon (¹²?XE) 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

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Duke Asthma Allergy and Airway Center	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ¹²?XE MRI VDP from Baseline to 24 weeks		Baseline up to Week 24
Primary	Rate of Moderate/Severe AEs		Baseline up to Week 48
Primary	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.	Baseline up to Week 48
Secondary	Absolute Change in Pre-bronchodilator FEV-1 (Liters)		Baseline up to Week 24
Secondary	Absolute Change in Pre-bronchodilator FEV-1 (Liters)		Baseline up to Week 48
Secondary	Number of Participant with Adverse Events With Severity Determined According To The World Health Organization (WHO) Toxicity Scale		Baseline up to 24 months