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NCT03219866 · ClinicalTrials.gov registry record · Phase 4
Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT03219866: Clinical Trial Phase 4 study, sponsored by Wake Forest University Health Sciences.
NCT03219866 is a Phase 4 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03219866, a Phase 4 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Scores range from 0 to 100, with higher scores indicating more limitations - Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall
Interventions
- DEVICE Dry Powder Inhaler
- DRUG Pulmicort
- DEVICE Nebulizers
- DRUG Brovana
- DRUG Atrovent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-10-03 |
| Est. Completion | 2020-04-01 |
| Phase | Phase 4 |
Why NCT03219866 stopped before completion
NCT03219866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Dry Powder Inhaler is the first listed.
NCT03219866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03219866 about?
NCT03219866 is a clinical study titled "Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)". 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 medicatio...
What is the current status of trial NCT03219866?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2017-10-03. Estimated completion is 2020-04-01.
What interventions are being tested in trial NCT03219866?
The interventions under investigation include: Dry Powder Inhaler (DEVICE), Pulmicort (DRUG), Nebulizers (DEVICE), Brovana (DRUG), Atrovent (DRUG).
Who is sponsoring clinical trial NCT03219866?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03219866's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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