Congestive Heart FailurePhase 2/3ACHENCT01375361
Nebulized Albuterol for Congestive Heart Failure Exacerbation
A Phase 2/3 study testing Albuterol and Normal Saline in people with Congestive Heart Failure, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Albuterol and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 with shortness of breath and history of CHF
- pulmonary edema on chest xr
Who cannot join
- pregnancy
- clinical or ekg changes to suggest acute coronary syndrome
- history of copd or asthma
- history of albuterol on medication list
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94143
About this study
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.
Read the detailed description
The objective is to carry out a randomized blinded placebo-controlled trial of inhaled Albuterol as an early therapy for patients with decompensated Congestive Heart Failure. Compared to placebo, inhaled Albuterol will improve oxygenation and decrease the need for non-invasive ventilation in patients with Cardiogenic Pulmonary Edema.
- Conditions
- Congestive Heart Failure
- Being tested
- Albuterol, Normal Saline
- Keywords
- albuterol
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuterolDrug
Also called Administration of Albuterol.
2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.
Normal SalineDrug
Also called Administration of Placebo.
2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours.
Secondary outcomes (1)
Admission
If the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions.
Measured: An average of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startApr 2009
- Primary completionJul 2010
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John C. Stein, MD., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375361
- Sponsor's protocol ID
- RandomizedAlbuterolCHF
- Acronym
- ACHE
- Status last verified
- Oct 2013
- First submitted
- 20 Apr 2010
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Albuterol for Congestive Heart Failure Exacerbation
- ClinicalTrials.gov ID
- NCT01375361
- Acronym / sponsor ID
- ACHE / RandomizedAlbuterolCHF
- Conditions
- Congestive Heart Failure
- Keywords
- albuterol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective is to carry out a randomized blinded placebo-controlled trial of inhaled Albuterol as an early therapy for patients with decompensated Congestive Heart Failure. Compared to placebo, inhaled Albuterol will improve oxygenation and decrease the need for non-invasive ventilation in patients with Cardiogenic Pulmonary Edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Albuterol | Experimental | Drug: AlbuterolPatients 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. |
| Inhaled Placebo. | Placebo comparator | Drug: Normal SalinePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-65 with shortness of breath and history of CHF
- pulmonary edema on chest xr
Key exclusion criteria (4 listed)
- pregnancy
- clinical or ekg changes to suggest acute coronary syndrome
- history of copd or asthma
- history of albuterol on medication list
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbuterolAlso: Administration of Albuterol.2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department. | Drug | Inhaled Albuterol |
| Normal SalineAlso: Administration of Placebo.2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department. | Drug | Inhaled Placebo. |
Primary outcome
Borg Dyspnea Score
Time frame: 8 hours.
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.
1 secondary outcome
Admission
Time frame: An average of 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C. Stein, MD. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Albuterol and Normal Saline in people with Congestive Heart Failure, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg Dyspnea Score (time frame: 8 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2013.