Nebulizer Versus Dry Powdered Inhalers for COPD

Drugs used to treat COPD are available primarily in hand held inhaler devices that deliver
dry powder (DPI), a soft mist or a metered dose of spray (MDI). The frail, arthritic elderly
are often prescribed DPI rather than MDI or soft mist devices, because they require less
coordination. DPIs however require the ability to inhale against a resistance with a peak
inspiratory force (PIF) more negative than 60 L/min to break the dry powder into respirable
particles. Preliminary data suggests that suboptimal PIF's are common during an acute
exacerbation of COPD, affecting 48% of hospitalized patients, thus placing them at risk for
treatment failure and possibly hospital readmission. Use of nebulizers to administer
respiratory medications may avoid the hazards of insufficient dosing that can result from use
of DPI however they are cumbersome, expensive and the variety of drugs available in a
nebulizer format is limited. We hypothesize that patients treated in hospital and is charged
on respiratory medications administered by nebulizers will exhibit better symptom control and
lower COPD and all cause hospital readmission rates compared with patients treated with
respiratory medications delivered by DPI. We aim to demonstrate that 1) patients treated and
discharged on nebulized bronchodilators will have fewer readmissions to hospital at 30 and 90
days compared to the group utilizing DPI 2) that the nebulizer group will demonstrate a
longer duration of time till hospital readmission for COPD and all cause readmission compared
to the group utilizing DPI and 3) the nebulizer group will demonstrate better symptom control
compared to the group utilizing DPI. This nonblinded feasibility (pilot) study will enroll
100 patients hospitalized for an exacerbation of COPD who are > 40 years of age, have a
clinical diagnosis of COPD. The study will consist of 3 outpatient visits (Transitional Care
Visit [314 days after discharge], Visit #2 [30 +/5 days after discharge], and Visit #3 [90
+/5 days after discharge]). Visit #2 and #3 are for study purposes, the Transitional Care
Visit is standard of care. We hypothesize and aim to demonstrate that patients treated in
hospital and discharged on respiratory medications administered by nebulizers will exhibit
better quality of life (QoL), symptom control and lower COPD and all cause hospital
readmission rates compared with patients treated with respiratory medications delivered by
DPI.

Inclusion Criteria:

- > 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

- Able to give informed consent

Exclusion Criteria:

- Dementia

- Active cancer

- End stage cardiovascular disease

- Inability to attend outpatient visits

- Active Schizophrenia

Pregnancy; subjects will be excluded if female and are not post-menopausal for at least one
year. Since there is no possible benefit from participating in this protocol for a pregnant
woman, we will exclude pregnant women. If a subject is found to be pregnant during the
90-day study period, they will be excluded from the study and their data not used for study
purposes.