Trial Outcomes & Findings for Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT03219866)
NCT ID: NCT03219866
Last Updated: 2021-06-22
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
90 Days
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
Nebulizers
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Age, Continuous
|
61 years
n=93 Participants
|
64 years
n=4 Participants
|
63 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
19 participants
n=4 Participants
|
40 participants
n=27 Participants
|
|
BMI
|
29.9 kg/m2
n=93 Participants
|
25.4 kg/m2
n=4 Participants
|
27.4 kg/m2
n=27 Participants
|
PRIMARY outcome
Timeframe: 90 DaysScores 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
Outcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)
|
49.3 score on a scale
Standard Deviation 25.2
|
43.7 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: 90 DaysThe 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.
Outcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Symptom Control Measured by the COPD Assessment Test (CAT)
|
19.2 score on a scale
Standard Deviation 9.0
|
16.5 score on a scale
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: 90 DaysThe 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.
Outcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Symptom Control Measured by The Modified Medical Research Council Dyspnea Scale (mMRC)
|
2.1 score on a scale
Standard Deviation 1.6
|
1.6 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 30 DaysCompare the number of hospital readmissions between the two arms after 30 days of using each device.
Outcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
COPD and All-Cause Hospital Readmissions After 30 Days
|
1 number of readmissions
|
3 number of readmissions
|
SECONDARY outcome
Timeframe: 90 DaysCompare the number of hospital readmissions between the two arms after 90 days of using each device.
Outcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
COPD and All-Cause Hospital Readmissions After 90 Days
|
2 number of readmissions
|
4 number of readmissions
|
SECONDARY outcome
Timeframe: 90 DaysCompare the number of unscheduled clinic or ER visits between the two arms after 90 days of using each device
Outcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Unscheduled Clinic or ER Visits
|
4 number of visits
|
4 number of visits
|
SECONDARY outcome
Timeframe: Baseline and 90 daysPulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
Outcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -2 (Low to Medium Resistance Inhalers)
|
73.9 cmH2O
Standard Deviation 5.9
|
74.2 cmH2O
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Number of Deaths
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 90 daysPulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
Outcome measures
| Measure |
Nebulizers
n=21 Participants
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 Participants
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -5 (High Resistance Inhalers)
|
43.7 cmH2O
Standard Deviation 2.2
|
46.5 cmH2O
Standard Deviation 4.9
|
Adverse Events
Nebulizers
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Dry Powder Inhaler
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nebulizers
n=21 participants at risk
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).
Nebulizers: Patients treated and discharged on nebulized bronchodilators
Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
|
Dry Powder Inhaler
n=19 participants at risk
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers
Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalizations
|
4.8%
1/21 • Number of events 1 • 90 days
|
15.8%
3/19 • Number of events 3 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Re-admissions into Hospital
|
9.5%
2/21 • Number of events 2 • 90 days
|
21.1%
4/19 • Number of events 4 • 90 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place