Clinical trial NCT02266875: Nebulized Hypertonic Saline for Inpatient Use in COPD
Official title: Nebulized Hypertonic Saline for Inpatient Use in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale
timeFrame: Pre-treatment (baseline) vs. 24 hours post-treatment
Secondary outcomes:
measure: 30 Day Readmission
timeFrame: 30 days post discharge
measure: 30 Day All Cause Mortality
timeFrame: 30 days post discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Doctors Hospital
state: Ohio
Study officials:
affiliation: OhioHealth
name: Kruti Patel, DO
role: PRINCIPAL_INVESTIGATOR
References: