Status AsthmaticusNCT00279786
B2-Adrenergic Receptor Polymorphisms
An observational study of Status Asthmaticus, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
Beta(2)-adrenergic receptor (BAR) agonists are the most important group of drugs used in the treatment of asthma. In children unresponsive to inhaled BAR agonist therapy, higher dose systemic BAR agonist therapy is frequently the next step in treatment. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Status Asthmaticus
- What is being tested?
- Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jan 2009
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children admitted to the ICU with severe asthma exacerbations
Who may be able to join
- (1) Admission to the CCMC PICU with a primary admission diagnosis of status asthmaticus. (2) Age between 2 years and 18 years.
Who cannot join
- Pre-existing chronic disease (other than asthma)
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: B2-Adrenergic Receptor Polymorphisms: Implications For The Treatment Of Status Asthmaticus In Children
Beta(2)-adrenergic receptor (BAR) agonists are the most important group of drugs used in the treatment of asthma. In children unresponsive to inhaled BAR agonist therapy, higher dose systemic BAR agonist therapy is frequently the next step in treatment. Despite the widespread use of intravenous BAR agonist therapy for pediatric status asthmaticus, there is controversy regarding the efficacy of this therapy. A number of studies have established that genetic variations of the BAR have important effects in modulating responses to BAR agonist therapy for asthma. In particular, changes in amino acid position 16 of the BAR gene are thought to be the most functionally important. Patients encoded for two glycine amino acids, rather than arginine, at this position appear to have more severe asthma and to respond differently to acute BAR agonist therapy.
Our hypothesis is that genotypic differences may contribute to poor response to acute BAR agonist treatment. We propose to conduct a prospective observational study to determine the influence of a patient's BAR genotype on the response to acute BAR agonist therapy.
Read more
Our specific hypothesis is that children with genetic polymorphisms of the gene encoding the BAR will have a decreased response to acute high-dose continuous BAR therapy (both inhaled and intravenous) compared to other children.
Our primary outcome is ICU length of stay. Secondary outcomes are
- to assess the rate of improvement in clinical asthma score based on genotype, and
- to attempt to correlate asthma phenotype with genotype by comparing demographic data and hospital course.
Read the detailed description
This study has both a prospective and a retrospective arm. In the retrospective arm, patients with a history of admission to the ICU with a severe asthma exacerbation are contacted by phone and mail and DNA samples are obtained via saliva. In the prospective arm, patients admitted to the ICU are contacted prospectively and DNA is obtained either via saliva or blood.
- Conditions
- Status Asthmaticus
- Being tested
- Blood draw
- Keywords
- pediatric
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
Also called genotyping of ß2-AR at position 16 and 27.
blood drawn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionJan 2009
- Study completionJan 2009
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Carroll, MD, Principal investigator, CT Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279786
- Sponsor's protocol ID
- 06-001
- Status last verified
- Jul 2009
- First submitted
- 18 Jan 2006
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B2-Adrenergic Receptor Polymorphisms: Implications For The Treatment Of Status Asthmaticus In Children
- ClinicalTrials.gov ID
- NCT00279786
- Acronym / sponsor ID
- 06-001
- Conditions
- Status Asthmaticus
- Keywords
- pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Jan 2006 (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.
Beta(2)-adrenergic receptor (BAR) agonists are the most important group of drugs used in the treatment of asthma. In children unresponsive to inhaled BAR agonist therapy, higher dose systemic BAR agonist therapy is frequently the next step in treatment. Despite the widespread use of intravenous BAR agonist therapy for pediatric status asthmaticus, there is controversy regarding the efficacy of this therapy. A number of studies have established that genetic variations of the BAR have important effects in modulating responses to BAR agonist therapy for asthma. In particular, changes in amino acid position 16 of the BAR gene are thought to be the most functionally important. Patients encoded for two glycine amino acids, rather than arginine, at this position appear to have more severe asthma and to respond differently to acute BAR agonist therapy.
Our hypothesis is that genotypic differences may contribute to poor response to acute BAR agonist treatment. We propose to conduct a prospective observational study to determine the influence of a patient's BAR genotype on the response to acute BAR agonist therapy.
Our specific hypothesis is that children with genetic polymorphisms of the gene encoding the BAR will have a decreased response to acute high-dose continuous BAR therapy (both inhaled and intravenous) compared to other children.
Our primary outcome is ICU length of stay. Secondary outcomes are
- to assess the rate of improvement in clinical asthma score based on genotype, and
- to attempt to correlate asthma phenotype with genotype by comparing demographic data and hospital course.
Detailed description
This study has both a prospective and a retrospective arm. In the retrospective arm, patients with a history of admission to the ICU with a severe asthma exacerbation are contacted by phone and mail and DNA samples are obtained via saliva. In the prospective arm, patients admitted to the ICU are contacted prospectively and DNA is obtained either via saliva or blood.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children admitted to the ICU with severe asthma exacerbations
Key inclusion criteria (1 listed)
- (1) Admission to the CCMC PICU with a primary admission diagnosis of status asthmaticus. (2) Age between 2 years and 18 years.
Key exclusion criteria (1 listed)
- Pre-existing chronic disease (other than asthma)
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 |
|---|---|---|
| Blood drawAlso: genotyping of ß2-AR at position 16 and 27.blood drawn | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 30 Nov 2023.
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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?
An observational study of 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 1 inclusion and 1 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 30 Nov 2023. 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.
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.
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 30 Nov 2023.