Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)

• Status: Terminated
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a non-blinded feasibility (pilot) study comparing triple therapy nebulizer vs dry powdered inhalers (DPI) for care transitions in Chronic obstructive pulmonary disease (COPD) exacerbation patients.

We hypothesize 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.

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. The nebulizer group will demonstrate a longer duration of time until hospital readmission for COPD and all cause readmission compared to the group utilizing DPI

3. The nebulizer group will demonstrate better QoL (measured by the SGRQ - Saint George Respiratory Questionnaire) and symptom control (as measured by the CAT & mMRC) compared to the group utilizing DPI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Budesonide; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Ipratropium; Tiotropium Bromide

Criteria

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.