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A Phase II, Randomized, Double-Blind, Placebo- Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis
Rochester, Minn.
This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).
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A Phase III, Randomised, Double-blind, Placebo-controlled Study To Assess The Efficacy, Safety, And Tolerability Of BI 1291583 2.5 Mg Administered Once Daily For Up To 76 Weeks In Patients With Bronchiectasis (The AIRTIVITY® Study)
Rochester, Minn.,
Jacksonville, Fla.
This study is open to adults with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).
The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.
Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants complete a daily diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.
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Bronchiectasis Research Registry
Rochester, Minn.,
Jacksonville, Fla.
The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) bronchiectasis patients from major clinical and research institutions. The goal of the Registry is to support collaborative research and assist in the planning of multi-center clinical trials for the treatment of non-CF bronchiectasis, a progressive, chronic disease of the lungs which afflicts thousands of patients. The Registry is also to be used to provide better insight into the diagnosis, pathophysiology etiologies, and management approaches of the different types of bronchiectasis.
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CRISPR detection of circulating cell-free Mycobacterium avium complex (MAC) DNA for rapid diagnosis and monitoring of MAC pulmonary disease
Rochester, Minn.
The purpose of this study is to conduct analytic and clinical validation of a CRISPR-based blood test for MAC cellfree DNA as a measure of MAC pulmonary disease activity and treatment response. This biomarker could ultimately be used to guide diagnostic and therapeutic decision-making with regard to MAC pulmonary disease.
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Patient reported outcomes in patients with nontuberculous mycobacterial pulmonary disease
Rochester, Minn.
The purpose of this study is e to better understand the trajectory of patient-reported outcomes (PROs), e.g. respiratory symptoms and health-related quality of life (HRQoL), across the entire disease course and measure toxicity and tolerability using patient-reported symptomatic adverse events in treated patients with nontuberculous mycobacterial pulmonary disease (NTM-PD). Secondary objectives are to create a data repository to be linked to future claims, electronic health record, and/or other existing databases and a biorepository of blood samples.
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Closed for Enrollment
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A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) PROMIS II (PROMIS)
Rochester, Minn.
To assess the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa.
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Time to First Pulmonary Exacerbation, Safety and Efficacy of ARD-3150 (Dual Release Ciprofloxacin for Inhalation-DRCFI) Compared With Placebo in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis (ORBIT-3)
Rochester, Minn.
The DRCFI treatment will influence the time to first pulmonary exacerbation compared to placebo.
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A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) (MAHALE)
Rochester, Minn.
The purpose of this study is to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation (NCFB+EI). All patients who complete the 52-week double-blind treatment period on investigational product (IP) may be eligible to continue into an open-label extension (OLE), during which all patients will receive benralizumab. The OLE treatment period is intended to allow patients at least one year of treatment with open label benralizumab.
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A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects with Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (Tailwind)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to evaluate the effectiveness, safety, and phage kinetics of multiple inhaled doses of AP-PA02 administered as monotherapy and administered in combination with inhaled antibiotics compared to placebo and inhaled antibiotics alone.
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the
Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study (ASPEN)
Rochester, Minn.
The purpose of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.The study protocol allows for children ages 12-18 years to be enrolled; however, Mayo Clinic will not be enrolling any subjects <18 years old.
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A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation (Arikayce) in Patients with Recalcitrant Nontuberculous Mycobacterial Lung Disease
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness, safety and tolerability of Amikacin for patients who have a mycobacterial lung disease that is not tuberculosis, and is difficult to treat.
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A Randomized, Open-label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients With Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC) That Are Refractory to Treatment (CONVERT)
Rochester, Minn.
A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) when added to multi-drug regimen in subjects with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC).
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ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung
Infection Caused by Mycobacterium avium Complex (MAC) (ARISE)
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints.
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ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC) (ENCORE)
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness of ALIS + azithromycin (AZI) + ethambutol (ETH) compared to the empty liposome control (ELC) + AZI + ETH on patient reported respiratory symptoms at Month 13.
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INS312 - An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Non-Tuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium Avium Complex (MAC) that are Refractory to Treatment
Rochester, Minn.
The purpose of this extension study is to assess the safety, tolerability, and effectiveness of Liposomal Amikacin for Inhalation added to a multi-drug regimen in subjects with non-tuberculous mycobacterium lung infections due to Mycobacterium avium complex who were resistant to therapy in Study INS-212.
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Multicenter Randomized Pragmatic Clinical Trial Comparing Two- versus Three-Antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
Rochester, Minn.
The purpose of this study is to determine whether 2-drug therapy is non-inferior to 3-drug therapy against pulmonary mycobacterium avium complex (MAC) disease, and whether 2-drug therapy is better tolerated than 3-drug therapy.
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Prospective Phase 0 Study to Investigate Pseudomonas aeruginosa and Staphylococcus aureus Bacterial Load, Patient Characteristics and Exploratory Biomarkers in Adult Patients with Cystic Fibrosis or Non-Cystic Fibrosis Bronchiectasis
Rochester, Minn.
The purpose of this study is to investigate Pseudomonas Aeruginosa and Staphylococcus Aureus bacterial
load, patient characteristics and exploratory biomarkers in adult patients with Cystic Fibrosis or
Non-Cystic Fibrosis Bronchiectasis.
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Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis (RESPIRE 2)
Rochester, Minn.
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.
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