Nebulized Hypertonic Saline for Inpatient Use in COPD

NCT02266875 | Completed Phase 4 Results

• 1 other identifier: 14-0050
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 30 Day Readmission

  30 days post discharge

• 30 Day All Cause Mortality

  30 days post discharge

Study Arms (2)

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.

Drug: hypertonic saline

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.

Drug: standard saline

Interventions

hypertonic saline DRUG

Hypertonic Saline

standard saline DRUG

Standard Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

Doctors Hospital

Columbus, Ohio, 43228, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Kruti Patel, DO
• Organization: OhioHealth

kruti.patel@ohiohealth.com

614-857-7735

Study Officials

• Kruti Patel, DO

  OhioHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: January 30, 2017
• Study Completion: January 30, 2017
• Last Updated: November 22, 2017
• Results First Posted: November 22, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)