N/A
N=90,089
Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis
Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT02714283 ↗Enrolled (actual)
90,089
Serious AEs
—
Results posted
Jul 2019
Primary outcome: Primary: Nontuberculous Mycobacterial (NTM) Disease — 188; 32 Events — p=0.19
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- inhaled corticosteroid therapy (Drug); macrolide therapy (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nontuberculous Mycobacterial (NTM) Disease |
188; 32 | 0.19 |
| PRIMARY Hospitalized Respiratory Infection |
4213; 317 | <0.0001 sig |
| SECONDARY Sudden Cardiac Arrest |
892; 81 | 0.21 |
| SECONDARY Sensorineural Hearing Loss |
2574; 347 | <0.0001 sig |
| SECONDARY Hip Fracture |
919; 77 | 0.87 |
| SECONDARY Opportunistic Infections |
1585; 180 | 0.23 |
| SECONDARY All-cause Mortality |
3362; 270 | 0.20 |
| SECONDARY All-cause Hospitalization |
17939; 1352 | <0.0001 sig |
| SECONDARY Hemoptysis |
253; 31 | 0.99 |
| SECONDARY Arrhythmia |
9508; 728 | 0.0005 sig |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02714283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.