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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714283
• Other study ID #: CER-1503-29191
• Status: Completed
• Start date: October 28, 2016
• Est. completion date: July 1, 2018

Study information

• Verified date: September 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90089
• Est. completion date: July 1, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• cystic fibrosis diagnosis, HIV infection, history of organ transplant

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• inhaled corticosteroid therapy
We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies
• macrolide therapy
We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Oregon Health and Science University	COPD Foundation, National Jewish Health, Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham

References & Publications (3)

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. — View Citation

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. — View Citation

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). pii: 1801896. doi: 10.1183/13993003.01896-2018. P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nontuberculous Mycobacterial (NTM) Disease	Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease	up to 8 years
Primary	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.	up to 8 years
Secondary	Sudden Cardiac Arrest	Myocardial infarction event	up to 8 years
Secondary	Sensorineural Hearing Loss	Sensorineural hearing loss.	up to 8 years
Secondary	Hip Fracture	Hip fracture.	up to 8 years
Secondary	Opportunistic Infections	Opportunistic infections.	up to 8 years
Secondary	All-cause Mortality	All-cause mortality.	up to 8 years
Secondary	All-cause Hospitalization	All-cause hospitalization.	up to 8 years
Secondary	Hemoptysis	Hemoptysis event	up to 8 years
Secondary	Arrhythmia	Arrhythmia (principal diagnosis)	up to 8 years