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Comparative effectiveness and safety of inhaled corticosteroids and antimicrobial compounds for non-cystic fibrosis (non-CF) bronchiectasis
Investigator (PI): Winthrop, Kevin
Performing Organization (PO): (Current): Oregon Health and Science University, School of Medicine, Department of Medicine, Division of Infectious Diseases / (503) 494-7735
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2020
Record Source/Award ID: PCORI/CER-1503-29191
Funding: Total Award Amount: $1,867,968
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Non-cystic fibrosis (non-CF) bronchiectasis is an increasingly common rare lung disease that causes long-term disability in 100,000 older Americans. The disease is characterized by lung inflammation and growth of bacteria and other organisms in the lungs. Although treatments for non-CF bronchiectasis are given with the goals of reducing lung inflammation and infection, we know very little about how well these drugs work and how safe they are in the long term. We plan to compare the benefits and harms of steroids, primarily inhaled corticosteroids (ICS), and antibiotics used in patients with non-CF bronchiectasis. The project will be guided by bronchiectasis patients who serve on a patient advisory panel. The patient advocacy groups COPD Foundation and NTM Info & Research (NTMir), as well as lung and infectious disease doctors, will participate in the project. Using Medicare data, we will compare the risks and benefits of ICS and antibiotics (specifically macrolides antibiotics). We will do this by comparing the risks of various outcomes in non-CF bronchiectasis patients who have taken ICS versus those who have used antibiotics. We will also study patients who use both simultaneously. Our main hypothesis is that long-term ICS use might harm patients by increasing the risk of pneumonia hospitalization and of acquiring nontuberculous mycobacteria and other opportunistic infections. Alternatively, it is likely that chronic macrolide use might protect against these outcomes. These outcomes were identified as important by non-CF bronchiectasis patients who helped us develop this project application. We will include patients as active study investigators; during the study we will attempt to identify additional drug comparisons and outcomes of interest to patients in order to integrate such findings into our study methods, as applicable. After completion of our study, we will communicate the results and recommendations to non-CF bronchiectasis patients and their physicians through a number of channels. The COPD Foundation and NTMir will lead this effort. Our patient partners will review results and help decide what the important messages for patients and doctors are. Because patients will be involved throughout the project, including deciding what the important questions are, we expect results to be meaningful. We believe that our findings will provide both doctors and patients with a better understanding of the risks and benefits of their therapies, such that patients will be able to choose safer and more effective treatments for this chronic, disabling disease.
MeSH Terms:
  • Administration, Inhalation
  • Adrenal Cortex Hormones /*administration & dosage
  • Aged
  • Anti-Bacterial Agents /administration & dosage
  • Anti-Infective Agents /*administration & dosage
  • Bronchiectasis /*drug therapy
  • Comparative Effectiveness Research
  • Humans
  • Inflammation
  • Lung /physiopathology
  • Macrolides /administration & dosage
  • Medicare
  • Mycobacterium /metabolism
  • Opportunistic Infections /drug therapy
  • Outcome Assessment, Health Care
  • Pneumonia /drug therapy
  • Risk
  • United States
Country: United States
State: Oregon
Zip Code: 97239
UI: 20162114
CTgovId: NCT02714283
Project Status: Ongoing
Record History: ('2020: Project extended to 2020\n2019: Project extended to 2019',)