BronchiectasisNCT02714283

Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis

An observational study of Bronchiectasis, run by Oregon Health and Science University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to provide patients and their physicians with greater understanding of the risks and benefits of commonly used therapies for treatment of non-CF bronchiectasis Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Bronchiectasis
What is being tested?: inhaled corticosteroid therapy and macrolide therapy
How many people: 90,089 participants
Where: No sites listed yet
Study dates: 28 Oct 2016to 1 Jul 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Study population: Patients within Medicare with a diagnosis of bronchiectasis

Who may be able to join

Within Medicare data, indicated diagnosis of Bronchiectasis by a Pulmonologist (ICD-9 code 494.0 and/or 494.1)

Who cannot join

cystic fibrosis diagnosis, HIV infection, history of organ transplant

About this study

The purpose of this study is to provide patients and their physicians with greater understanding of the risks and benefits of commonly used therapies for treatment of non-CF bronchiectasis

Read the detailed description

Non-CF bronchiectasis is a chronic inflammatory lung disease that is closely linked to pulmonary NTM disease. Both are rare but rising in incidence and disproportionately affect the elderly and women. Therapy of non-CF bronchiectasis aims to reduce inflammation via either ICS-induced immunosuppression or antibiotic-associated immunomodulation and/or suppression of pathogenic organisms. Both strategies, pursued long-term alone or some cases concomitantly, have inherent risks, and the relative risks and benefits of these differential approaches are poorly studied to date. Ultimately, our study will provide patients and their physicians with greater understanding of the risks and benefits of these therapeutic choices.

Conditions: Bronchiectasis
Being tested: inhaled corticosteroid therapy, macrolide therapy
Keywords: nontuberculous mycobacteria, corticosteroids, macrolides, antibiotics
Medical subject headings: Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

inhaled corticosteroid therapyDrug
We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies
macrolide therapyDrug
Also called azithromycin, erythromycin
We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies

Study groups in NCT02714283
Study group	Role	What they receive
Non-CF bronchiectasis patients		Complete national 2006-2014 Medicare data from Part A, B and D will be obtained from CMS. We will use bronchiectasis ICD-9 codes 494.0 and 494.1 to identify patients with bronchiectasis within Medicare. From this identified bronchiectasis cohort, we will exclude patients with cystic fibrosis (ICD-9 codes 277.00-277.09), HIV infection (042), and a history of organ transplant (V42.0, V42.1, V42.6, V42.7, V42.8). Receives: Drug: inhaled corticosteroid therapy; Drug: macrolide therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Nontuberculous Mycobacterial (NTM) Disease
Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease
Measured: up to 8 years
Hospitalized Respiratory Infection
Among a national cohort of non-CF bronchiectasis patients, we will compare the effectiveness of corticosteroid and macrolide therapy with regards to prevention of hospitalized respiratory infection.
Measured: up to 8 years

Secondary outcomes (8)

Sudden Cardiac Arrest
Myocardial infarction event
Measured: up to 8 years
Sensorineural Hearing Loss
Sensorineural hearing loss.
Measured: up to 8 years
Hip Fracture
Hip fracture.
Measured: up to 8 years
Opportunistic Infections
Opportunistic infections.
Measured: up to 8 years
All-cause Mortality
All-cause mortality.
Measured: up to 8 years
All-cause Hospitalization
All-cause hospitalization.
Measured: up to 8 years
Hemoptysis
Hemoptysis event
Measured: up to 8 years
Arrhythmia
Arrhythmia (principal diagnosis)
Measured: up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 20161 Jul 2018

First posted21 Mar 2016 (estimated)
Study start28 Oct 2016
Primary completion30 Jun 2018
Study completion1 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for BronchiectasisStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 90,089 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02714283
Sponsor's protocol ID: CER-1503-29191
Status last verified: Sep 2019
First submitted: 15 Mar 2016
Last updated: 18 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992 Jun;45(6):613-9. doi: 10.1016/0895-4356(92)90133-8.
PubMed 1607900
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716
Henkle E, Curtis JR, Chen L, Chan B, Aksamit TR, Daley CL, Griffith DE, Winthrop KL. Comparative risks of chronic inhaled corticosteroids and macrolides for bronchiectasis. Eur Respir J. 2019 Jul 18;54(1):1801896. doi: 10.1183/13993003.01896-2018. Print 2019 Jul.
PubMed 31000676

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Not yet recruitingPhase 3
A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)
Bronchiectasis

All Bronchiectasis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis
ClinicalTrials.gov ID: NCT02714283
Acronym / sponsor ID: CER-1503-29191
Conditions: Bronchiectasis
Keywords: nontuberculous mycobacteria, corticosteroids, macrolides, antibiotics
Study type: Observational
Recruitment status: Completed
Enrolment: 90,089 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham, National Jewish Health, COPD Foundation
Study start: 28 Oct 2016 (actual)
Primary completion: 30 Jun 2018 (actual)
Study completion: 1 Jul 2018 (actual)
First posted: 21 Mar 2016 (estimated)
Results: Posted 12 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to provide patients and their physicians with greater understanding of the risks and benefits of commonly used therapies for treatment of non-CF bronchiectasis

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Non-CF bronchiectasis patients	–	Drug: inhaled corticosteroid therapy, Drug: macrolide therapyComplete national 2006-2014 Medicare data from Part A, B and D will be obtained from CMS. We will use bronchiectasis ICD-9 codes 494.0 and 494.1 to identify patients with bronchiectasis within Medicare. From this identified bronchiectasis cohort, we will exclude patients with cystic fibrosis (ICD-9 codes 277.00-277.09), HIV infection (042), and a history of organ transplant (V42.0, V42.1, V42.6, V42.7, V42.8).

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Patients within Medicare with a diagnosis of bronchiectasis

Key inclusion criteria (1 listed)

Within Medicare data, indicated diagnosis of Bronchiectasis by a Pulmonologist (ICD-9 code 494.0 and/or 494.1)

Key exclusion criteria (1 listed)

cystic fibrosis diagnosis, HIV infection, history of organ transplant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
inhaled corticosteroid therapyWe will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies	Drug	Non-CF bronchiectasis patients
macrolide therapyAlso: azithromycin, erythromycinWe will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies	Drug	Non-CF bronchiectasis patients

Primary outcome

Nontuberculous Mycobacterial (NTM) Disease
Time frame: up to 8 years
Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease
Hospitalized Respiratory Infection
Time frame: up to 8 years
Among a national cohort of non-CF bronchiectasis patients, we will compare the effectiveness of corticosteroid and macrolide therapy with regards to prevention of hospitalized respiratory infection.

8 secondary outcomes

Sudden Cardiac Arrest
Time frame: up to 8 years
Sensorineural Hearing Loss
Time frame: up to 8 years
Hip Fracture
Time frame: up to 8 years
Opportunistic Infections
Time frame: up to 8 years
All-cause Mortality
Time frame: up to 8 years
All-cause Hospitalization
Time frame: up to 8 years
Hemoptysis
Time frame: up to 8 years
Arrhythmia
Time frame: up to 8 years

Results and safety

Results posted to the registry on 12 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inhaled Corticosteroids (ICS)	83,589	83,589
Macrolide Monotherapy	6,500	6,500

Primary outcome: Nontuberculous Mycobacterial (NTM) Disease

Time frame: up to 8 years. Number. Unit: Events

Measure	Inhaled Corticosteroids (ICS) n = 16136	Macrolide Monotherapy n = 1496
Value	188	32

Inhaled Corticosteroids (ICS) vs Macrolide Monotherapy: Hazard Ratio (HR): 0.77 (95% CI 0.51 to 1.14), p = 0.19, Regression, Cox

Population analysed: Analysis population excluded all patients with a history of NTM treatment or diagnosis prior to exposure start.

Primary outcome: Hospitalized Respiratory Infection

Time frame: up to 8 years. Number. Unit: Events

Measure	Non-CF Bronchiectasis Patients on ICS Monotherapy n = 83495	Non-CF Bronchiectasis Patients on Macrolide Monotherapy n = 6498
Value	4213	317

Non-CF Bronchiectasis Patients on ICS Monotherapy vs Non-CF Bronchiectasis Patients on Macrolide Monotherapy: Hazard Ratio (HR): 1.39 (95% CI 1.23 to 1.57), p <0.0001, Regression, Cox

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: This is a retrospective observational study. Only medical history data was collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-CF Bronchiectasis Patients on ICS Monotherapy	0 of 0	0 of 0	0
Non-CF Bronchiectasis Patients on Macrolide Monotherapy	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Claims-based data limits our ability to confirm bronchiectasis diagnoses and include disease symptoms/severity in our models. Results may not be applicable to \<65 year old bronchiectasis patients who have a lower underlying risk of pneumonia.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1607900Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992 Jun;45(6):613-9. doi: 10.1016/0895-4356(92)90133-8.
Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Results publication: PubMed 31000676Henkle E, Curtis JR, Chen L, Chan B, Aksamit TR, Daley CL, Griffith DE, Winthrop KL. Comparative risks of chronic inhaled corticosteroids and macrolides for bronchiectasis. Eur Respir J. 2019 Jul 18;54(1):1801896. doi: 10.1183/13993003.01896-2018. Print 2019 Jul.
Individual participant dataSharing planned: No

Related trials for Bronchiectasis

RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Not yet recruitingPhase 3
A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)
Bronchiectasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kevin L Winthrop, MD, MPH principal investigator

Oregon Health and Science University

Emily Henkle, PhD, MPH study director

Oregon Health and Science University

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiectasis, run by Oregon Health and Science University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nontuberculous Mycobacterial (NTM) Disease (time frame: up to 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714283, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.