Nebulizer Versus Dry Powdered Inhalers for COPD
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|ClinicalTrials.gov Identifier: NCT03219866|
Recruitment Status : Terminated (Lower enrollment than Sponsor expected - Sponsor stopped study)
First Posted : July 18, 2017
Last Update Posted : October 5, 2020
This will be a non-blinded feasibility (pilot) study comparing triple therapy nebulizer vs dry powdered inhalers (DPI) for care transitions in 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:
- Patients treated and discharged on nebulized bronchodilators will have fewer readmissions to hospital at 30 and 90 days compared to the group utilizing DPI
- 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
- 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.
|Condition or disease||Intervention/treatment||Phase|
|COPD COPD Exacerbation||Device: Nebulizers Device: Dry Powder Inhaler Drug: Brovana Drug: Pulmicort Drug: Atrovent Drug: Advair Diskus Drug: Spiriva HandiHaler||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Study for Comparison of Triple Therapy Nebulizer Versus Dry Powdered Inhaler for Care Transitions in COPD|
|Actual Study Start Date :||October 3, 2017|
|Actual Primary Completion Date :||April 1, 2020|
|Actual Study Completion Date :||April 1, 2020|
Subjects will receive a long-acting B2-agonist (LABA; Brovana, twice daily), corticosteroid (ICS; Pulmicort, twice daily), and a short-acting anti-cholinergic (SAMA; Atrovent, three times a day).
Patients treated and discharged on nebulized bronchodilators
Other Name: Nebulizer Arm
Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Other Name: LABA
Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Other Name: ICS
Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
Other Name: SAMA
Experimental: Dry Powder Inhaler
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Device: Dry Powder Inhaler
Patients treated and discharged on Dry Powder Inhalers
Other Name: DPI Arm
Drug: Advair Diskus
Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Other Name: LABA, ICS
Drug: Spiriva HandiHaler
Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
Other Name: LAMA
- Quality of Life measured by SGRQ [ Time Frame: 90 Days ]The Saint George Respiratory Questionnaire measures health impairment in patients with asthma and COPD. Each component of the questionnaire is scored separately in 3 steps: The weights for all items with a positive responses are summed, the weights for missed items are deducted, and the score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage: Score=100 x Summed weights from positive items in that component. The Total score is calculated in similar way: Score=100 x Summed weights from positive items in the questionnaire. Sum of maximum possible weights for each component and Total: Symptom=662.5, Activity=1209.1, Impacts=2117.8, Total=3989.4 (these are the maximum possible weights that could be obtained for the worst possible state of the patient). Thus a higher score would represent a worse outcome, as the state of the patient is deemed worse than if they have a lower score.
- Symptom Control measured by CAT [ Time Frame: 90 Days ]The COPD Assessment Test (CAT) is a patient-completed instrument that can quantify the impact of COPD on the patient's health. The CAT is a validated, short (8-item) and simple patient completed questionnaire.The CAT has a scoring range of 0-40 and a difference or change of 2 or more units over 2 to 3 months in a patient suggests a clinically significant difference or change in health status. A score of >30 indicates that COPD has a very high impact on daily life, a score of >20 indicates a high impact, 10-20 is medium impact, <10 is low impact, and 5 is the upper limit for healthy non-smokers. A higher score would represent a poor outcome for this test.
- Symptom Control measured by mMRC [ Time Frame: 90 Days ]The Modified Medical Research Council Dyspnea Scale, or MMRC, uses a simple grading system to assess a patient's level of dyspnea -- shortness of breath. The scale goes from 0-4 with a 0 = I only get breathless with strenuous exercise, 1 = I get short of breath when hurrying on level ground or walking up a slight hill, 2 = On level ground, I walk slower than people of the same age because of breathlessness or have to stop for breath when walking at my own pace, 3 = I stop for breath after walking about 100 yards or after a few minutes on level ground, and 4 = I am too breathless to leave the house or I am breathless when dressing. 4 would represent the worst outcome.
- COPD and All-Cause Hospital Readmissions after 30 Days [ Time Frame: 30 Days ]Compare the number of hospital readmissions between the two arms after 30 days of using each device.
- COPD and All-Cause Hospital Readmissions after 90 Days [ Time Frame: 90 Days ]Compare the number of hospital readmissions between the two arms after 90 days of using each device.
- Unscheduled Clinic of ER visits [ Time Frame: 90 Days ]Compare the number of unscheduled clinic or ER visits between the two arms after 90 days of using each device
- PIF measured at baseline during hospitalization and at each study visit [ Time Frame: 90 Days ]Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219866
|United States, North Carolina|
|Wake Forest Baptist Health|
|Winston-Salem, North Carolina, United States, 27104|
|Principal Investigator:||Jill A Ohar, MD, FCCP||Professor of Internal Medicine|