Trial Outcomes & Findings for Nebulized Hypertonic Saline for Inpatient Use in COPD (NCT NCT02266875)

NCT ID: NCT02266875

Last Updated: 2017-11-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: Pre-treatment (baseline) vs. 24 hours post-treatment
• Results posted on: 2017-11-22

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	40	30
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	11	0

Reasons for withdrawal

Measure	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	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
Overall Study Withdrawal by Subject	9	0
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hypertonic Saline n=29 Participants 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	Standard Saline n=30 Participants 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	Total n=59 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 8.4 • n=29 Participants	63.3 years STANDARD_DEVIATION 9.8 • n=30 Participants	61.2 years STANDARD_DEVIATION 9.3 • n=59 Participants
Sex: Female, Male Female	13 Participants n=29 Participants	17 Participants n=30 Participants	30 Participants n=59 Participants
Sex: Female, Male Male	16 Participants n=29 Participants	13 Participants n=30 Participants	29 Participants n=59 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Pre-treatment Score: Modified Borg Dyspnea Scale	5.1 units on a scale STANDARD_DEVIATION 1.6 • n=29 Participants	4.4 units on a scale STANDARD_DEVIATION 2.2 • n=30 Participants	4.8 units on a scale STANDARD_DEVIATION 2.0 • n=59 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hypertonic Saline n=29 Participants 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	Standard Saline n=30 Participants 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
Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale	-1.4 units on a scale Standard Deviation 1.6	-1.0 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 30 days post discharge

Documented hospital readmission 30 days post discharge

Outcome measures

Measure	Hypertonic Saline n=29 Participants 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	Standard Saline n=30 Participants 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 Day Readmission	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days post discharge

Documented mortality at 30 days post discharge

Outcome measures

Measure	Hypertonic Saline n=29 Participants 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	Standard Saline n=30 Participants 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 Day All Cause Mortality	0 Participants	0 Participants

Adverse Events

Hypertonic Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kruti Patel, DO

OhioHealth

Phone: 614-857-7735

Email: kruti.patel@ohiohealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place