COPDPhase 4NCT01151579
Effect of Nebulized Bronchodilators on Heart Rate
A Phase 4 study testing Levalbuterol and Albuterol in people with COPD and Sepsis, run by Fahim Khorfan, MD at 1 site in United States.
Trial summary
The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Levalbuterol and Albuterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions
Who cannot join
- Known allergy or sensitivity to study medications
- Baseline heart rate was greater than 110 beats per minute
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
Official title: Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients
The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.
Read the detailed description
A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.
- Being tested
- Levalbuterol, Albuterol
- Keywords
- Tachycardia, tachyarrhythmias, bronchodilator therapy, Critically ill patients
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sepsis, Shock, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevalbuterolDrug
Also called Xopenex, ipratropium
inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg
AlbuterolDrug
Also called Salbutamol
Nebulized albuterol 2.5mg
| Study group | Role | What they receive |
|---|---|---|
| Levalbuterol 0.63 | Active comparator | Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg. Receives: Drug: Levalbuterol; Drug: Albuterol |
| Levalbuterol 1.25 | Active comparator | Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. Receives: Drug: Levalbuterol; Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate in Beats Per Minute
Average difference in Heart rate between pre and post breathing treatments
Measured: Five days
Secondary outcomes (2)
Arrhythmias
Any new arrhythmia documented in the medical record that occurred between breathing treatments.
Measured: 15 minutes after each treatment for average of 3 to 5 days
Total Number of Participants With Arrhythmias
Documented new arrhythmia occurring during study.
Measured: Five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fahim Khorfan, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ascension Health
- Responsible party
- Sponsor-investigator, Fahim Khorfan, MD, Ascension Health
- Investigators
- Fahim Khorfan, MD, Principal investigator, Ascension HealthKimberly R Barber, PhD, Study director, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151579
- Sponsor's protocol ID
- ME 07-0011
- Status last verified
- Sep 2015
- First submitted
- 24 Jun 2010
- Last updated
- 23 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Khorfan FM, Smith P, Watt S, Barber KR. Effects of nebulized bronchodilator therapy on heart rate and arrhythmias in critically ill adult patients. Chest. 2011 Dec;140(6):1466-1472. doi: 10.1378/chest.11-0525. Epub 2011 Sep 29.
PubMed 21960699
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients
- ClinicalTrials.gov ID
- NCT01151579
- Acronym / sponsor ID
- ME 07-0011
- Keywords
- Tachycardia, tachyarrhythmias, bronchodilator therapy, Critically ill patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Fahim Khorfan, MDIndustry (pharma, biotech, devices)
- Collaborators
- Ascension Health
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Posted 23 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.
Detailed description
A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levalbuterol 0.63 | Active comparator | Drug: Levalbuterol, Drug: AlbuterolPatients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg. |
| Levalbuterol 1.25 | Active comparator | Drug: Levalbuterol, Drug: AlbuterolPatients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions
Key exclusion criteria (2 listed)
- Known allergy or sensitivity to study medications
- Baseline heart rate was greater than 110 beats per minute
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 |
|---|---|---|
| LevalbuterolAlso: Xopenex, ipratropiuminhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg | Drug | Levalbuterol 0.63, Levalbuterol 1.25 |
| AlbuterolAlso: SalbutamolNebulized albuterol 2.5mg | Drug | Levalbuterol 0.63, Levalbuterol 1.25 |
Primary outcome
Heart Rate in Beats Per Minute
Time frame: Five days
Average difference in Heart rate between pre and post breathing treatments
2 secondary outcomes
Arrhythmias
Time frame: 15 minutes after each treatment for average of 3 to 5 days
Total Number of Participants With Arrhythmias
Time frame: Five days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21960699Khorfan FM, Smith P, Watt S, Barber KR. Effects of nebulized bronchodilator therapy on heart rate and arrhythmias in critically ill adult patients. Chest. 2011 Dec;140(6):1466-1472. doi: 10.1378/chest.11-0525. Epub 2011 Sep 29.
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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.
Fahim Khorfan, MD principal investigator
Ascension Health
Kimberly R Barber, PhD study director
Ascension Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levalbuterol and Albuterol in people with COPD and Sepsis, run by Fahim Khorfan, MD 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 23 Oct 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Heart Rate in Beats Per Minute (time frame: Five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151579, which also lists 1 linked publication.
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 23 Oct 2015.