Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD; COPD Exacerbation
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: Nebulizers; Dry Powder Inhaler; Brovana; Pulmicort; Atrovent; Advair Diskus; Spiriva HandiHaler
Intervention description: Patients treated and discharged on nebulized bronchodilators; Patients treated and discharged on Dry Powder Inhalers; Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily); Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily); Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day); Subjects will receive a LABA/ICS (Advair Diskus, twice daily); Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
Intervention MeSH terms: Budesonide; Tiotropium Bromide; Fluticasone-Salmeterol Drug Combination; Ipratropium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Nebulizer; Inhaler

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.
    

Eligibility 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.