Status AsthmaticusPhase 4NCT00124995
Trial of Terbutaline for the Treatment of Status Asthmaticus in Children
A Phase 4 study testing terbutaline in people with Status Asthmaticus, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Status Asthmaticus
- What is being tested?
- terbutaline
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2006
- Phase
- Phase 4
- 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 Up to 18 years
- All sexes
- Child, Adult
Who may be able to join
- Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus
- Modified Pulmonary Index Score (MPIS) of greater than or equal to 12
- Age between birth and 18 years old
Who cannot join
- Pre-existing cardiac or pulmonary disease
- Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation)
- Hemodynamic or cardiovascular instability requiring inotropic support
- The patient meets one of the criteria for withdrawal from the study due to patient safety concerns
Trial locations and contacts
1 site in 1 country.
United States1 site
CT Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.
- Conditions
- Status Asthmaticus
- Being tested
- terbutaline
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terbutalineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay
Secondary outcomes (2)
To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
To prospectively analyze the side effects of terbutaline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startOct 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status AsthmaticusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Carroll, MD, Connecticut Children's Medical Center
- Investigators
- Christopher Carroll, MD, Principal investigator, CT Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124995
- Sponsor's protocol ID
- 05-001
- Status last verified
- Feb 2013
- First submitted
- 27 Jul 2005
- Last updated
- 15 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
- ClinicalTrials.gov ID
- NCT00124995
- Acronym / sponsor ID
- 05-001
- Conditions
- Status Asthmaticus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 29 Jul 2005 (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.
Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus
- Modified Pulmonary Index Score (MPIS) of greater than or equal to 12
- Age between birth and 18 years old
Key exclusion criteria (4 listed)
- Pre-existing cardiac or pulmonary disease
- Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation)
- Hemodynamic or cardiovascular instability requiring inotropic support
- The patient meets one of the criteria for withdrawal from the study due to patient safety concerns
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 |
|---|---|---|
| terbutaline | Drug | – |
Primary outcome
ICU length of stay
2 secondary outcomes
To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
To prospectively analyze the side effects of terbutaline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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.
Christopher Carroll, MD principal investigator
CT Children's Medical Center
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 terbutaline in people with Status Asthmaticus, run by Connecticut Children's Medical Center 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 3 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: finished, as of the sponsor's last update on 15 Feb 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ICU length of stay. 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 15 Feb 2013.