AsthmaNCT01175174
Clinical, Airway Inflammatory, and HRA Phenotypes, in Preschool Children With Acute Asthmatic Attack Presenting to the ED.
An observational study of Asthma, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic attack presenting to the ED. Background: Children under the age of 5 years have the highest hospitalization rate of asthma. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Asthma
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Sep 2011
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children, age: 1-6 years old presenting to the emergency room (ER) with acute wheezing episode.
Who may be able to join
- children, age: 1-6 years old
- presenting to the ER with acute wheezing episode.
Who cannot join
- Any chronic (lung, cardiac, immunologic, neurologic) disease
Trial locations and contacts
1 site in 1 country.
About this study
Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic attack presenting to the ED.
Background:
Read more
Children under the age of 5 years have the highest hospitalization rate of asthma. The most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children < 6 y old are not atopic.
The inflammatory response to these mostly viral-induced asthmatic attacks is not well characterized in the literature. Moreover it is not known whether different kind of inflammatory responses exist in this population and how this correlate to clinical outcomes and clinical phenotypes in preschool children presenting ti the ED with acute asthmatic attack.
Therefore, the purpose of the present study is to:
Investigate the characterization of induced sputum cytology in preschool children with acute asthmatic attack and whether there is correlation between specific sputum cytology and response to therapy and to investigate airways hyper-responsiveness to adenosine 5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3 month following acute asthmatic exacerbation and look for correlation with response to treatment and sputum cytology. Clinical phenotypes of this patient population will also be investigated.
Read the detailed description
Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic attack presenting to the ED.
Background:
Children under the age of 5 years have the highest hospitalization rate of asthma. The most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children < 6 y old are not atopic.
The inflammatory response to these mostly viral-induced asthmatic attacks is not well characterized in the literature. Moreover it is not known whether different kind of inflammatory responses exist in this population and how this correlate to clinical outcomes and clinical phenotypes.
Therefore, the purpose of the present study is to:
Investigate the characterization of induced sputum cytology, bronchial hyper-responsiveness (BHR, and clinical phenotypes in preschool children with acute asthmatic attack presenting to the ED and whether there is correlation between specific sputum cytology and response to therapy.
and to investigate airways hyper-responsiveness (BHR)to adenosine 5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3 month following acute asthmatic exacerbation and look for correlation with response to treatment and sputum cytology.
Clinical phenotypes of this patient population will also be investigated.Clinical characteristics of the preschool children presenting to the ED with asthmatic attack will be compared to normal controls recruited from ambulatory clinics at the same area.
- Conditions
- Asthma
- Keywords
- asthma, preschool children, adenosine provocation test, metacholine provocation test, pediatric emergency department
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
airways inflammatory phenotype
Measured: Within 24 hours from admission to the emergency department (ED)
post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine
Measured: 1. Within 2 weeks of recruitment 2. After 3 moths from recruitment
Secondary outcomes (3)
Relationship between post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine and the response to treatment and cytologic phenotypes.
Measured: 1. Within 3 weeks of recruitment 2. Beyond 3 moths from recruitment
relationship between cytologic phenotypes and response to treatment.
Measured: Within 3 months of recruitmant
clinical phenotype
Clinical characteristics of the preschool children presenting to the ED with asthmatic attack will be compared to mormal controls recruited from ambulatory clinics at the same area.
Measured: whithin 1 month of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Avigdor Mandelberg, Wolfson Medical Center
- Investigators
- Avigdor Mandelberg, MD, Study chair, The Sackler School of Medicine, Tel Aviv University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175174
- Sponsor's protocol ID
- 1038-sputum
- Status last verified
- Sep 2011
- First submitted
- 2 Aug 2010
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Airway Inflammatory, and HRA Phenotypes, in Preschool Children With Acute Asthmatic Attack Presenting to the ED.
- ClinicalTrials.gov ID
- NCT01175174
- Acronym / sponsor ID
- 1038-sputum
- Conditions
- Asthma
- Keywords
- asthma, preschool children, adenosine provocation test, metacholine provocation test, pediatric emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Aug 2010 (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.
Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic attack presenting to the ED.
Background:
Children under the age of 5 years have the highest hospitalization rate of asthma. The most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children < 6 y old are not atopic.
The inflammatory response to these mostly viral-induced asthmatic attacks is not well characterized in the literature. Moreover it is not known whether different kind of inflammatory responses exist in this population and how this correlate to clinical outcomes and clinical phenotypes in preschool children presenting ti the ED with acute asthmatic attack.
Therefore, the purpose of the present study is to:
Investigate the characterization of induced sputum cytology in preschool children with acute asthmatic attack and whether there is correlation between specific sputum cytology and response to therapy and to investigate airways hyper-responsiveness to adenosine 5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3 month following acute asthmatic exacerbation and look for correlation with response to treatment and sputum cytology. Clinical phenotypes of this patient population will also be investigated.
Detailed description
Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic attack presenting to the ED.
Background:
Children under the age of 5 years have the highest hospitalization rate of asthma. The most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children < 6 y old are not atopic.
The inflammatory response to these mostly viral-induced asthmatic attacks is not well characterized in the literature. Moreover it is not known whether different kind of inflammatory responses exist in this population and how this correlate to clinical outcomes and clinical phenotypes.
Therefore, the purpose of the present study is to:
Investigate the characterization of induced sputum cytology, bronchial hyper-responsiveness (BHR, and clinical phenotypes in preschool children with acute asthmatic attack presenting to the ED and whether there is correlation between specific sputum cytology and response to therapy.
and to investigate airways hyper-responsiveness (BHR)to adenosine 5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3 month following acute asthmatic exacerbation and look for correlation with response to treatment and sputum cytology.
Clinical phenotypes of this patient population will also be investigated.Clinical characteristics of the preschool children presenting to the ED with asthmatic attack will be compared to normal controls recruited from ambulatory clinics at the same area.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children, age: 1-6 years old presenting to the emergency room (ER) with acute wheezing episode.
Key inclusion criteria (2 listed)
- children, age: 1-6 years old
- presenting to the ER with acute wheezing episode.
Key exclusion criteria (1 listed)
- Any chronic (lung, cardiac, immunologic, neurologic) disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
airways inflammatory phenotype
Time frame: Within 24 hours from admission to the emergency department (ED)
post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine
Time frame: 1. Within 2 weeks of recruitment 2. After 3 moths from recruitment
3 secondary outcomes
Relationship between post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine and the response to treatment and cytologic phenotypes.
Time frame: 1. Within 3 weeks of recruitment 2. Beyond 3 moths from recruitment
relationship between cytologic phenotypes and response to treatment.
Time frame: Within 3 months of recruitmant
clinical phenotype
Time frame: whithin 1 month of presentation
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 7 Sep 2011.
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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.
Avigdor Mandelberg, MD study chair
The Sackler School of Medicine, Tel Aviv University, Israel
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 Asthma, run by Wolfson Medical Center at 1 site in Israel.
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 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 7 Sep 2011. 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 Israel. 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.
What does the primary outcome measure?
airways inflammatory phenotype (time frame: Within 24 hours from admission to the emergency department (ED)). The study lists 2 primary outcomes in all. 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 7 Sep 2011.