A Phase 4 interventional study of hypertonic saline and standard saline in Chronic Obstructive Pulmonary Disease, sponsored by OhioHealth. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-22.
Sponsored by OhioHealth · Phase 4, Interventional, and Treatment
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.
4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 70 is close to the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →OhioHealth is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: hypertonic 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.
Drug: standard saline
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
30 Day Readmission
Documented hospital readmission 30 days post discharge
Time frame: 30 days post discharge
30 Day All Cause Mortality
Documented mortality at 30 days post discharge
Time frame: 30 days post discharge
| Milestone | Hypertonic Saline | Standard Saline |
|---|---|---|
| Started | 40 | 30 |
| Completed | 29 | 30 |
| Not completed | 11 | 0 |
| Withdrew: Withdrawal by subject | 9 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
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.
| units on a scale | Hypertonic Saline | Standard Saline |
|---|---|---|
| Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale | -1.4 ± 1.6 | -1.0 ± 2.1 |
Documented hospital readmission 30 days post discharge
| Participants | Hypertonic Saline | Standard Saline |
|---|---|---|
| 30 Day Readmission | 3 | 3 |
Documented mortality at 30 days post discharge
| Participants | Hypertonic Saline | Standard Saline |
|---|---|---|
| 30 Day All Cause Mortality | 0 | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypertonic Saline | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Standard Saline | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Hypertonic Saline | Standard Saline | Total |
|---|---|---|---|
| Mean | 58.9 ± 8.4 | 63.3 ± 9.8 | 61.2 ± 9.3 |
| Sex: Female, Male(Participants) | Hypertonic Saline | Standard Saline | Total |
|---|---|---|---|
| Female | 13 | 17 | 30 |
| Male | 16 | 13 | 29 |
| Race and Ethnicity Not Collected(Participants) | Hypertonic Saline | Standard Saline | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Pre-treatment Score: Modified Borg Dyspnea Scale(units on a scale) | Hypertonic Saline | Standard Saline | Total |
|---|---|---|---|
| Mean | 5.1 ± 1.6 | 4.4 ± 2.2 | 4.8 ± 2.0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No IPD will be shared
The record gives a start of Oct 2014, a primary completion of Jan 2017 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2017, 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →
OhioHealth