Preliminary study for comparison of triple therapy nebulizer versus dry powdered inhaler for care transitions in COPD

What we are studying

The purpose of the study is to compare two drug delivery devices for the treatment of COPD: nebulized therapies versus Dry Powered Inhalers (DPI). For the purpose of this study, medications delivered via nebulizer are: Brovana, Pulmicort and Atrovent, and medications delivered via DPI are: Spiriva and Advair. Both drug delivery devices and all medications are approved for use by the U.S. Food and Drug Administration (FDA).

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 40+

Eligibility Criteria

  • Inclusion- hospitalized for an exacerbation of COPD with the following:
    • At least 40 years of age
  • Clinical diagnosis of COPD
  • Smoking history > 10 pack years
  • Lung Function- FEV1/FVC or FEV1/SVC < 70% on bedside spirometry or previous baseline and FEV1/FVC or FEV1/SVC < 70% on clinic visit < 2 weeks from discontinuation
  • And able to give informed consent. Exclusion criteria include:
    • Dementia
  • Active cancer
  • End stage cardiovascular disease
  • Inability to attend outpatient visits
  • Active Schizophrenia

What is involved

  • 4 non-invasive pulmonary inspiratory force testing
  • 2 spirometry tests
  • Demographic/Past medical history collection. Questionnaires include 2 Montreal Cognitive Assessments (MOCA)
  • 4 Saint George Respiratory Questionnaires (SGRQ)
  • 3 Modified Medical Research Council Dyspnea Scale (mMRC)
  • 3 COPD Assessment Tests (CAT)
  • 3 patient preference assessments
  • Data collection of clinical outcomes at end of study

Compensation

A total of $100- $50 for completion of Visit 2 and $50 for completion of Visit 3

Contact Information

Study Coordinator
Jill Ohar
Email
johar@wakehealth.edu
Phone
336-713-2913
Principal Investigator
Jill Ohar

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.