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Nebulized Hypertonic Saline for Inpatient Use in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
hypertonic saline
standard saline
Sponsored by
OhioHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Doctors Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypertonic Saline

Standard Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

30 Day Readmission
Documented hospital readmission 30 days post discharge
30 Day All Cause Mortality
Documented mortality at 30 days post discharge

Full Information

First Posted
October 7, 2014
Last Updated
October 26, 2017
Sponsor
OhioHealth
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1. Study Identification

Unique Protocol Identification Number
NCT02266875
Brief Title
Nebulized Hypertonic Saline for Inpatient Use in COPD
Official Title
Nebulized Hypertonic Saline for Inpatient Use in Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertonic Saline
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Saline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
hypertonic saline
Intervention Type
Drug
Intervention Name(s)
standard saline
Primary Outcome Measure Information:
Title
Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale
Description
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
Secondary Outcome Measure Information:
Title
30 Day Readmission
Description
Documented hospital readmission 30 days post discharge
Time Frame
30 days post discharge
Title
30 Day All Cause Mortality
Description
Documented mortality at 30 days post discharge
Time Frame
30 days post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kruti Patel, DO
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doctors Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared

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Nebulized Hypertonic Saline for Inpatient Use in COPD

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