A Phase 4 interventional study of Nebulizers and Dry Powder Inhaler in COPD and COPD Exacerbation, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
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:
Drugs used to treat Chronic obstructive pulmonary disease (COPD) are available primarily in hand held inhaler devices that deliver dry powder (DPI), a soft mist or a metered dose of spray (MDI). The frail, arthritic elderly are often prescribed DPI rather than MDI or soft mist devices, because they require less coordination. DPIs however require the ability to inhale against a resistance with a peak inspiratory force (PIF) more negative than 60 L/min to break the dry powder into respirable particles. Preliminary data suggests that suboptimal PIF's are common during an acute exacerbation of COPD, affecting 48% of hospitalized patients, thus placing them at risk for treatment failure and possibly hospital readmission. Use of nebulizers to administer respiratory medications may avoid the hazards of insufficient dosing that can result from use of DPI however they are cumbersome, expensive and the variety of drugs available in a nebulizer format is limited. We hypothesize that patients treated in hospital and is charged on respiratory medications administered by nebulizers will exhibit better 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) that the nebulizer group will demonstrate a longer duration of time till hospital readmission for COPD and all cause readmission compared to the group utilizing DPI and 3) the nebulizer group will demonstrate better symptom control compared to the group utilizing DPI. This nonblinded feasibility (pilot) study will enroll 100 patients hospitalized for an exacerbation of COPD who are > 40 years of age, have a clinical diagnosis of COPD. The study will consist of 3 outpatient visits (Transitional Care Visit [314 days after discharge], Visit #2 [30 +/5 days after discharge], and Visit #3 [90 +/5 days after discharge]). Visit #2 and #3 are for study purposes, the Transitional Care Visit is standard of care. We hypothesize and aim to demonstrate 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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
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.
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).
Device: Nebulizers · Drug: Brovana · Drug: Pulmicort · Drug: Atrovent
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Device: Dry Powder Inhaler · Drug: Advair Diskus · Drug: Spiriva HandiHaler
Patients treated and discharged on nebulized bronchodilators
Also known as: Nebulizer Arm
Patients treated and discharged on Dry Powder Inhalers
Also known as: DPI Arm
Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Also known as: LABA
Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Also known as: ICS
Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
Also known as: SAMA
Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Also known as: LABA, ICS
Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
Also known as: LAMA
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)
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
Time frame: 90 Days
Symptom Control Measured by the COPD Assessment Test (CAT)
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.
Time frame: 90 Days
Symptom Control Measured by The Modified Medical Research Council Dyspnea Scale (mMRC)
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.
Time frame: 90 Days
COPD and All-Cause Hospital Readmissions After 30 Days
Compare the number of hospital readmissions between the two arms after 30 days of using each device.
Time frame: 30 Days
COPD and All-Cause Hospital Readmissions After 90 Days
Compare the number of hospital readmissions between the two arms after 90 days of using each device.
Time frame: 90 Days
Unscheduled Clinic or ER Visits
Compare the number of unscheduled clinic or ER visits between the two arms after 90 days of using each device
Time frame: 90 Days
Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -2 (Low to Medium Resistance Inhalers)
Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
Time frame: Baseline and 90 days
Number of Deaths
Time frame: 90 days
Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -5 (High Resistance Inhalers)
Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
Time frame: Baseline and 90 days
| Milestone | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Started | 21 | 19 |
| Completed | 21 | 19 |
| Not completed | 0 | 0 |
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
| score on a scale | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ) | 49.3 ± 25.2 | 43.7 ± 19.8 |
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.
| score on a scale | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Symptom Control Measured by the COPD Assessment Test (CAT) | 19.2 ± 9.0 | 16.5 ± 9.1 |
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.
| score on a scale | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Symptom Control Measured by The Modified Medical Research Council Dyspnea Scale (mMRC) | 2.1 ± 1.6 | 1.6 ± 1.3 |
Compare the number of hospital readmissions between the two arms after 30 days of using each device.
| number of readmissions | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| COPD and All-Cause Hospital Readmissions After 30 Days | 1 | 3 |
Compare the number of hospital readmissions between the two arms after 90 days of using each device.
| number of readmissions | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| COPD and All-Cause Hospital Readmissions After 90 Days | 2 | 4 |
Compare the number of unscheduled clinic or ER visits between the two arms after 90 days of using each device
| number of visits | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Unscheduled Clinic or ER Visits | 4 | 4 |
Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
| cmH2O | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -2 (Low to Medium Resistance Inhalers) | 73.9 ± 5.9 | 74.2 ± 4.2 |
| Participants | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Number of Deaths | 1 | 1 |
Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
| cmH2O | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -5 (High Resistance Inhalers) | 43.7 ± 2.2 | 46.5 ± 4.9 |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebulizers | 1/21 (4.8%) | 3/21 (14.3%) | 0/21 (0%) |
| Dry Powder Inhaler | 1/19 (5.3%) | 7/19 (36.8%) | 0/19 (0%) |
| Event | Nebulizers | Dry Powder Inhaler |
|---|---|---|
| Re-admissions into HospitalRespiratory, thoracic and mediastinal disorders | 2/21 | 4/19 |
| HospitalizationsRespiratory, thoracic and mediastinal disorders | 1/21 | 3/19 |
| Age, Categorical(Participants) | Nebulizers | Dry Powder Inhaler | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 11 | 25 |
| >=65 years | 7 | 8 | 15 |
| Age, Continuous(years) | Nebulizers | Dry Powder Inhaler | Total |
|---|---|---|---|
| Mean | 61 (57 to 66) | 64 (63 to 73) | 63 (58 to 67) |
| Sex: Female, Male(Participants) | Nebulizers | Dry Powder Inhaler | Total |
|---|---|---|---|
| Female | 15 | 8 | 23 |
| Male | 6 | 11 | 17 |
| Race (NIH/OMB)(Participants) | Nebulizers | Dry Powder Inhaler | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 5 | 6 |
| White | 19 | 14 | 33 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Nebulizers | Dry Powder Inhaler | Total |
|---|---|---|---|
| United States | 21 | 19 | 40 |
| BMI(kg/m2) | Nebulizers | Dry Powder Inhaler | Total |
|---|---|---|---|
| Mean | 29.9 (22.4 to 33.6) | 25.4 (17.9 to 32.3) | 27.4 (21.4 to 33.2) |
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Pulmonary Disease, Chronic Obstructive→
Wake Forest University Health Sciences