Current Bronchiectasis (BE) Research
Nutrition and Markers of Disease Severity in Patients With Bronchiectasis
Despotes KA, Choate R, Addrizzo-Harris D, et al. Chronic Obstructive Pulmonary Disease. 2020; 7(4): 390-403. doi: http://doi.org/10.15326/jcopdf.2020.0178
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)
Clinicaltrials.gov Identifier: NCT04594369
Phase:3
(See following Brensocatib (INS1007) study for a description of the drug)
Sponsors and Collaborations: Insmed Incorporated
October 2020-not yet recruiting
Contact: Tomoko Shibata at Insmed for more information-- tomoko.shibata@insmed.com
Assessment of INS1007 in subjects with Non-Cystic Fibrosis Bronchiectasis (Willow Study)
Brensocatib (formerly INS1007) is an oral drug, was studied to see whether it may be a non-antibiotic option for reducing exacerbations in people with BE. It works by inhibiting dipeptidyl peptidase 1 (DPP1) that causes an uncontrolled neutrophilic inflammation response associated with lung inflammation.
Clinicaltrials.gov Identifier: NCT03218917
Phase: 2 completed with plans to begin Phase 3
Sponsor: Insmed Incorporated
Study start date: December 2017
Completion date: December 2019
https://www.nejm.org/doi/full/10.1056/NEJMoa2021713
The BRIDGE Study—Bronchiectasis Research Involving Databases, Genomics and Endotyping
“There are several different treatment options for people with bronchiectasis but currently, doctors find it hard to understand which treatment suits each person best. This research will focus on choosing the right treatment for the right person for people living with bronchiectasis.
The aim is to create tests that can help match treatments to people by using state-of-the-art methods like gene sequencing and inflammation measurement technology. These methods will help categorise patients right down to cell level. That means researchers can see which treatment tends to work on which type of person. 1000 people with bronchiectasis from across Europe will be invited to take part in this research.” (Health Research Authority, NHS)
Clinicaltrials.gov Identifier: NCT03791086
Sponsor: University of Dundee/Dr. James D. Chalmers
Study start date: 2019-recruiting
Study of Hypertonic Saline and Carbocisteine in Bronchiectasis (CLEAR)
Clinicaltrials.gov description of research:
“Current guidelines for the management of BE highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum-removal as part of standard care. The investigators hypothesize that mucoactive agents (HTS or carbocisteine, or a combination of both) are effective in reducing exacerbations over a 52-week period, compared to usual care.”
ClinicalTrials.gov Identifier NCT04140214
Belfast Health and Social Care Trust
Study start date: June 2018
Estimated completion date: August 2021
Value of Inhaled treatment with Aztreonam Lysine in Bronchiectasis
ClinicalTrials.gov description of research:
“This trial will test the hypothesis that 12 months treatment with Aztreonam lysine (Cayston) for inhalation will be safe and well tolerated, and will result in a significant increase in the time to first pulmonary exacerbation in participants with bronchiectasis and a history of frequent exacerbations.”
ClinicalTrials.gov Identifier NCT03696290
Sponsor: University of Dundee
Collaborator: Gilead Sciences
Study start date: October 2018
Estimated completion date: October 2020
Clinical Effectiveness of High Frequency Chest Wall Oscillation (HFCWO) in a Bronchiectasis Population (HFCWO)
The study will look at whether using a HFCWO vest impacts the patients quality of life, frequency of exacerbation, lung function, sputum production, patient adherence to treatment, 6-minute walk test measurements and CT scan findings.
Clinical Trials Identifier NCT04271969
Sponsor: Electromed Inc.
Collaborator: University of Alabama at Birmingham
Study start date: February 2020
Estimated completion date: June 2021
Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients with Bronchiectasis
Roflumilast is a phosphodiesterase-4 inhibitor with an anti-inflammatory effect. It inhibits an enzyme that is responsible for lung disease progression and has been shown to be effective in patients with COPD. This study looks at whether Roflumilast also has an anti-inflammatory effect with BE patients. Specifically, whether it impacts quality of life, shortness of breath and lung function.
Clinicaltrials.gov Identifier: NCT03988816
Sponsor: University of Sao Paulo General Hospital
Collaborator: FAPESP
Study start date: December 2019
Estimated completion date: December 2020
Association between physical activity and risk of hospitalization in bronchiectasis
European Respiratory Journal 2020
DOI:10.1183/13993003.02138-2019
Airway Mucus Hyperconcentration in Non-Cystic Fibrosis Bronchiectasis
American Journal of Respiratory and Critical Care Medicine. 2020
DOI: 10.1164/rccm.201906-1219OC
The radiological diagnosis of bronchiectasis: what’s in a name?
European Respiratory Review 2020
DOI:10.1183/16000617.0120-2019
Research on Non-tuberculous Mycobacteria Lung Disease (often a co-morbidity of BE)
Study of SPR720 for the Treatment of Patients with Mycobacterium Avium Complex (MAC)
The first oral replication inhibitor (SPR720) created specifically for the Treatment of MAC Pulmonary Disease by Spero Therapeutics is being tested against Clarithromycin plus ethambutol or Azithromycin plus ethambutol. Laboratory studies have shown that SPR720 might also be effective against Mycobacterium abscessus and Mycobacterium kansasaii.
Clinicaltrials.gov Identifier: NCT04553406
Phase: 2a
Sponsor: Spero Therapeutics
Study start date: October 2020
Estimated completion date: February 2022
https://sperotherapeutics.com/pipeline/spr720-non-tuberculosis-mycobacterium
Comparison of Two-Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease (MAC2v3)
"To date, most of the evidence underlying the current treatment recommendations has come from observational studies in which either a macrolide has been combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The proposed study will answer whether a third drug is necessary or whether taking two drugs can increase tolerability without a substantial loss of efficacy." (clinicaltrials.gov)
Clinicaltrials.gov Identifier: NCT03672630
Phase:3
Sponsor: Kevin Winthrop
Collaborators:
Patient-Centered Outcomes Research Institute
National Jewish Health
The University of Texas Health Science Center at Tyler
University Health Network, Toronto
New York University (and more)
Start start date: February 2019
Estimated completion date: February 2023
Inhaled Gaseous Nitric Oxide (gNO) antimicrobial treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
“Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, (and) help the patients breath better” (clinincaltrials.gov)
ClinincalTrials.gov Identifier: NCT03331445
Phase: 2
Sponsor: Chris Miller, Nitric Solutions, Incorporated
Collaborator: Mallinckrodt Pharmaceuticals
Study start date: October 2017
Estimated completion date: March 2021
Nutrition and Markers of Disease Severity in Patients With Bronchiectasis
Despotes KA, Choate R, Addrizzo-Harris D, et al. Chronic Obstructive Pulmonary Disease. 2020; 7(4): 390-403. doi: http://doi.org/10.15326/jcopdf.2020.0178
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)
Clinicaltrials.gov Identifier: NCT04594369
Phase:3
(See following Brensocatib (INS1007) study for a description of the drug)
Sponsors and Collaborations: Insmed Incorporated
October 2020-not yet recruiting
Contact: Tomoko Shibata at Insmed for more information-- tomoko.shibata@insmed.com
Assessment of INS1007 in subjects with Non-Cystic Fibrosis Bronchiectasis (Willow Study)
Brensocatib (formerly INS1007) is an oral drug, was studied to see whether it may be a non-antibiotic option for reducing exacerbations in people with BE. It works by inhibiting dipeptidyl peptidase 1 (DPP1) that causes an uncontrolled neutrophilic inflammation response associated with lung inflammation.
Clinicaltrials.gov Identifier: NCT03218917
Phase: 2 completed with plans to begin Phase 3
Sponsor: Insmed Incorporated
Study start date: December 2017
Completion date: December 2019
https://www.nejm.org/doi/full/10.1056/NEJMoa2021713
The BRIDGE Study—Bronchiectasis Research Involving Databases, Genomics and Endotyping
“There are several different treatment options for people with bronchiectasis but currently, doctors find it hard to understand which treatment suits each person best. This research will focus on choosing the right treatment for the right person for people living with bronchiectasis.
The aim is to create tests that can help match treatments to people by using state-of-the-art methods like gene sequencing and inflammation measurement technology. These methods will help categorise patients right down to cell level. That means researchers can see which treatment tends to work on which type of person. 1000 people with bronchiectasis from across Europe will be invited to take part in this research.” (Health Research Authority, NHS)
Clinicaltrials.gov Identifier: NCT03791086
Sponsor: University of Dundee/Dr. James D. Chalmers
Study start date: 2019-recruiting
Study of Hypertonic Saline and Carbocisteine in Bronchiectasis (CLEAR)
Clinicaltrials.gov description of research:
“Current guidelines for the management of BE highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum-removal as part of standard care. The investigators hypothesize that mucoactive agents (HTS or carbocisteine, or a combination of both) are effective in reducing exacerbations over a 52-week period, compared to usual care.”
ClinicalTrials.gov Identifier NCT04140214
Belfast Health and Social Care Trust
Study start date: June 2018
Estimated completion date: August 2021
Value of Inhaled treatment with Aztreonam Lysine in Bronchiectasis
ClinicalTrials.gov description of research:
“This trial will test the hypothesis that 12 months treatment with Aztreonam lysine (Cayston) for inhalation will be safe and well tolerated, and will result in a significant increase in the time to first pulmonary exacerbation in participants with bronchiectasis and a history of frequent exacerbations.”
ClinicalTrials.gov Identifier NCT03696290
Sponsor: University of Dundee
Collaborator: Gilead Sciences
Study start date: October 2018
Estimated completion date: October 2020
Clinical Effectiveness of High Frequency Chest Wall Oscillation (HFCWO) in a Bronchiectasis Population (HFCWO)
The study will look at whether using a HFCWO vest impacts the patients quality of life, frequency of exacerbation, lung function, sputum production, patient adherence to treatment, 6-minute walk test measurements and CT scan findings.
Clinical Trials Identifier NCT04271969
Sponsor: Electromed Inc.
Collaborator: University of Alabama at Birmingham
Study start date: February 2020
Estimated completion date: June 2021
Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients with Bronchiectasis
Roflumilast is a phosphodiesterase-4 inhibitor with an anti-inflammatory effect. It inhibits an enzyme that is responsible for lung disease progression and has been shown to be effective in patients with COPD. This study looks at whether Roflumilast also has an anti-inflammatory effect with BE patients. Specifically, whether it impacts quality of life, shortness of breath and lung function.
Clinicaltrials.gov Identifier: NCT03988816
Sponsor: University of Sao Paulo General Hospital
Collaborator: FAPESP
Study start date: December 2019
Estimated completion date: December 2020
Association between physical activity and risk of hospitalization in bronchiectasis
European Respiratory Journal 2020
DOI:10.1183/13993003.02138-2019
Airway Mucus Hyperconcentration in Non-Cystic Fibrosis Bronchiectasis
American Journal of Respiratory and Critical Care Medicine. 2020
DOI: 10.1164/rccm.201906-1219OC
The radiological diagnosis of bronchiectasis: what’s in a name?
European Respiratory Review 2020
DOI:10.1183/16000617.0120-2019
Research on Non-tuberculous Mycobacteria Lung Disease (often a co-morbidity of BE)
Study of SPR720 for the Treatment of Patients with Mycobacterium Avium Complex (MAC)
The first oral replication inhibitor (SPR720) created specifically for the Treatment of MAC Pulmonary Disease by Spero Therapeutics is being tested against Clarithromycin plus ethambutol or Azithromycin plus ethambutol. Laboratory studies have shown that SPR720 might also be effective against Mycobacterium abscessus and Mycobacterium kansasaii.
Clinicaltrials.gov Identifier: NCT04553406
Phase: 2a
Sponsor: Spero Therapeutics
Study start date: October 2020
Estimated completion date: February 2022
https://sperotherapeutics.com/pipeline/spr720-non-tuberculosis-mycobacterium
Comparison of Two-Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease (MAC2v3)
"To date, most of the evidence underlying the current treatment recommendations has come from observational studies in which either a macrolide has been combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The proposed study will answer whether a third drug is necessary or whether taking two drugs can increase tolerability without a substantial loss of efficacy." (clinicaltrials.gov)
Clinicaltrials.gov Identifier: NCT03672630
Phase:3
Sponsor: Kevin Winthrop
Collaborators:
Patient-Centered Outcomes Research Institute
National Jewish Health
The University of Texas Health Science Center at Tyler
University Health Network, Toronto
New York University (and more)
Start start date: February 2019
Estimated completion date: February 2023
Inhaled Gaseous Nitric Oxide (gNO) antimicrobial treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
“Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, (and) help the patients breath better” (clinincaltrials.gov)
ClinincalTrials.gov Identifier: NCT03331445
Phase: 2
Sponsor: Chris Miller, Nitric Solutions, Incorporated
Collaborator: Mallinckrodt Pharmaceuticals
Study start date: October 2017
Estimated completion date: March 2021