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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic Saline | Experimental | 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. |
|
| Standard Saline | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypertonic saline | Drug |
| ||
| standard saline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-treatment (baseline) vs. 24 hours post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Day Readmission | Documented hospital readmission 30 days post discharge | 30 days post discharge |
| 30 Day All Cause Mortality | Documented mortality at 30 days post discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kruti Patel, DO | OhioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doctors Hospital | Columbus | Ohio | 43228 | United States |
No IPD will be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment (baseline) vs. 24 hours post-treatment |
|
Data on adverse events was collected during subject admission period, from the time of study enrollment (baseline) until they were discharged from the hospital, ending their study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kruti Patel, DO | OhioHealth | 614-857-7735 | kruti.patel@ohiohealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2016 | Sep 28, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2016 | Sep 28, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| 30 days post discharge |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Pre-treatment Score: 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." | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 |
|
|
|
| Secondary | 30 Day Readmission | Documented hospital readmission 30 days post discharge | Posted | Count of Participants | Participants | 30 days post discharge |
|
|
|
|
| Secondary | 30 Day All Cause Mortality | Documented mortality at 30 days post discharge | Posted | Count of Participants | Participants | 30 days post discharge |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |