Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale scores after 4 treatments within 24 hours.
Detailed description
Hypothesis: A clinically significant difference exists between albuterol treatments with nebulized 3% saline versus standard saline, for improvements in the patient's modified Borg dyspnea score during an acute exacerbation of COPD.Study Population: This study will involve 146 patients admitted to Doctors Hospital in Columbus, Ohio from September 2014 through September 2015 with a clinical diagnosis of an acute exacerbation of COPD, defined as an increase in the patient's dyspnea, cough, or change in sputum consistency/volume/color from the patient's baseline during stable conditions. Study Design: Patients will be randomly assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or hypertonic saline. Once the patient is enrolled, they will be randomly assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or hypertonic saline. They will then receive the 2.5mg albuterol treatment, and saline solution as determined by the randomization plan (Group 1 will receive 0.9% saline and Group 2 will receive 3% saline), every six hours for at least the first 24 hours, with allowance for PRN (pro re nata= as needed) use every four hours by patient request. The patient's dyspnea will be evaluated prior to starting the treatment and after the intervention period is completed using the Modified Borg Dyspnea Scale.
Interventions
DRUGhypertonic saline
DRUGstandard saline
Sponsors
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years of age * Admitted to Doctors Hospital with a clinical diagnosis of COPD * Documented obstruction on spirometry from prior records available at the time of the study.
Exclusion criteria
* Patients younger than 18 years of age * Spirometry data not available * History of smoking less than twenty pack-years * Possibility of other primary cause of the patient's change in dyspnea or cough (e.g. pneumonia, congestive heart failure with pulmonary edema, myocardial infarction) * Patient is found to have a different primary cause after initial enrollment * Non-English speaking subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale | Pre-treatment (baseline) vs. 24 hours post-treatment | This is a patient-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, wherein 0 indicates no difficulty breathing, and 10 indicates a maximal difficulty in breathing. Patients may report in whole numbers, from 0 to 10, in addition to reporting 0.5, which indicates very, very slight (just noticeable) difficulty in breathing. A negative change in score indicates a reduction in patient-reported breathing difficulty. The greater the negative change, the better the patient-reported breathing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Day Readmission | 30 days post discharge | Documented hospital readmission 30 days post discharge |
| 30 Day All Cause Mortality | 30 days post discharge | Documented mortality at 30 days post discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypertonic Saline Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).
Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.
hypertonic saline | 29 |
| Standard Saline Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).
Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.
standard saline | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 0 |
Baseline characteristics
| Characteristic | Hypertonic Saline | Standard Saline | Total |
|---|---|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 8.4 | 63.3 years STANDARD_DEVIATION 9.8 | 61.2 years STANDARD_DEVIATION 9.3 |
| Pre-treatment Score: Modified Borg Dyspnea Scale | 5.1 units on a scale STANDARD_DEVIATION 1.6 | 4.4 units on a scale STANDARD_DEVIATION 2.2 | 4.8 units on a scale STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 17 Participants | 30 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale
This is a patient-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, wherein 0 indicates no difficulty breathing, and 10 indicates a maximal difficulty in breathing. Patients may report in whole numbers, from 0 to 10, in addition to reporting 0.5, which indicates very, very slight (just noticeable) difficulty in breathing. A negative change in score indicates a reduction in patient-reported breathing difficulty. The greater the negative change, the better the patient-reported breathing.
Time frame: Pre-treatment (baseline) vs. 24 hours post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertonic Saline | Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale | -1.4 units on a scale | Standard Deviation 1.6 |
| Standard Saline | Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale | -1.0 units on a scale | Standard Deviation 2.1 |
p-value: 0.32t-test, 2 sided
Secondary
30 Day All Cause Mortality
Documented mortality at 30 days post discharge
Time frame: 30 days post discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hypertonic Saline | 30 Day All Cause Mortality | 0 Participants |
| Standard Saline | 30 Day All Cause Mortality | 0 Participants |
Secondary
30 Day Readmission
Documented hospital readmission 30 days post discharge
Time frame: 30 days post discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hypertonic Saline | 30 Day Readmission | 3 Participants |
| Standard Saline | 30 Day Readmission | 3 Participants |
p-value: >0.999Fisher Exact