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

NCT03219866 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-22

Study results available
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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.

Conditions

  • COPD
  • COPD Exacerbation

Interventions

DEVICE

Nebulizers

Patients treated and discharged on nebulized bronchodilators

DEVICE

Dry Powder Inhaler

Patients treated and discharged on Dry Powder Inhalers

DRUG

Brovana

Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)

DRUG

Pulmicort

Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)

DRUG

Atrovent

Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)

DRUG

Advair Diskus

Subjects will receive a LABA/ICS (Advair Diskus, twice daily)

DRUG

Spiriva HandiHaler

Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Jill A Ohar, MD, FCCP · Professor of Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2020-04-01
Completion
2020-04-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03219866 on ClinicalTrials.gov