Nebulized Albuterol for Congestive Heart Failure Exacerbation

NCT01375361 | Withdrawn Phase 2 DMC

• 1 other identifier: RandomizedAlbuterolCHF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized trial of the use of Albuterol in the setting of acute decompensated Congestive Heart Failure with radiographic evidence of Cardiogenic Pulmonary Edema.

Conditions

Congestive Heart Failure

Keywords

albuterol

Outcome Measures

Primary Outcomes (1)

• Borg Dyspnea Score

  Patients are evaluated for approximatly 8 hours with the Borg Dyspnea Score. Starting at the time of arrival, then one hour later and consequently every two hours until reaching 8 hours in total. The Borg score is used to quantify the degree of shortness of breath a person is experiencing which is a measured on a 10 point visual-analog scale.

  8 hours.

Secondary Outcomes (1)

• Admission

  An average of 48 hours

Study Arms (2)

Inhaled Albuterol

EXPERIMENTAL

Patients identified to have Cardiogenic Pulmonary Edema, will receive 2.5mg of Albuterol nebulizer on enrollment in the study and again at 4 hours. Patients will be monitored on telemetry in the emergency department during and after study drug administration. Although study drug administration will cease after 4 hours, we will continue to record ongoing data during the patient's hospitalization.

Drug: Albuterol

Inhaled Placebo.

PLACEBO COMPARATOR

Patients identified to have Cardiogenic Pulmonary Edema will receive 2.5mg Normal saline inhaled (Placebo) on enrollment and at 4 hours in the emergency department. Patient will be monitor on telemetry in the emergency department during and after placebo administration.

Drug: Normal Saline

Interventions

Albuterol DRUG

2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.

Also known as: Administration of Albuterol.

Inhaled Albuterol

Normal Saline DRUG

2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.

Also known as: Administration of Placebo.

Inhaled Placebo.

Eligibility Criteria

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

You may qualify if:

• age 18-65 with shortness of breath and history of CHF
• pulmonary edema on chest xr

You may not qualify if:

• pregnancy
• clinical or ekg changes to suggest acute coronary syndrome
• history of copd or asthma
• history of albuterol on medication list

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Albuterol; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• John C. Stein, MD.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: June 17, 2011
• Study Start: April 1, 2009
• Primary Completion: July 1, 2010
• Last Updated: October 10, 2013

Record last verified: 2013-10

Locations

US (1)