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Completed

NCT Number: NCT02266875

Nebulized Hypertonic Saline for Inpatient Use in COPD

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Doctors Hospital

Columbus, Ohio, 43228, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic saline

Drug

standard saline

Drug

Primary outcomes

  1. Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale

    Time frame: 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.

Secondary outcomes

  1. 30 Day Readmission

    Time frame: 30 days post discharge

    Documented hospital readmission 30 days post discharge

  2. 30 Day All Cause Mortality

    Time frame: 30 days post discharge

    Documented mortality at 30 days post discharge

Sponsors and collaborators

Lead sponsor

OhioHealth

Other

Registry information

Official study title

Nebulized Hypertonic Saline for Inpatient Use in Chronic Obstructive Pulmonary Disease

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2014
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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