AsthmaNCT00969670
Correlation of Particulate Matter and Heme Oxygenase-1 Protein Activity in Asthmatic Children by Induced Sputum Analysis.
An observational study of Asthma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Samples of sputum from asthmatic children, between 5-17 years, will be collected during two years of the study period to perform tests Particle Size Distribution (PSD) and Shape Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate the activity of Heme Oxygenase-1 protein in… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to not given
- 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center
Who may be able to join
- •All children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center that there parents gave informed written consent for their child's participation in the study.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pulmonary Laboratory of Tel Aviv Sourasky Medical Center
Tel Aviv
Elizabeth Fierman, PhD, lizif@tasmc.health.gov.il
Daria Bliznuk, BcS, dasha_bl@yahoo.com
About this study
Samples of sputum from asthmatic children, between 5-17 years, will be collected during two years of the study period to perform tests Particle Size Distribution (PSD) and Shape Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate the activity of Heme Oxygenase-1 protein in sputum cell supernatants.
Each child will perform Pulmonary Function Testing (PFT) and Induced Sputum (IS) as a routine part of diagnosis of asthma.
Parents will be asked to complete a questionnaire including questions on their child's respiratory symptoms in the last 12 months as well as socioeconomic factors. Parents will be asked to give informed written consent for their child's participation in the study.
- Conditions
- Asthma
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startOct 2009
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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969670
- Sponsor's protocol ID
- TASMC-09-LF-242-CTIL
- Status last verified
- Nov 2009
- First submitted
- 29 Aug 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Particulate Matter and Heme Oxygenase-1 Protein Activity in Asthmatic Children by Induced Sputum Analysis.
- ClinicalTrials.gov ID
- NCT00969670
- Acronym / sponsor ID
- TASMC-09-LF-242-CTIL
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2009
- First posted
- 1 Sep 2009 (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.
Samples of sputum from asthmatic children, between 5-17 years, will be collected during two years of the study period to perform tests Particle Size Distribution (PSD) and Shape Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate the activity of Heme Oxygenase-1 protein in sputum cell supernatants.
Each child will perform Pulmonary Function Testing (PFT) and Induced Sputum (IS) as a routine part of diagnosis of asthma.
Parents will be asked to complete a questionnaire including questions on their child's respiratory symptoms in the last 12 months as well as socioeconomic factors. Parents will be asked to give informed written consent for their child's participation in the study.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center
Key inclusion criteria (1 listed)
- •All children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center that there parents gave informed written consent for their child's participation in the study.
Key exclusion criteria (1 listed)
- None.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
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 Tel-Aviv Sourasky 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 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: status not confirmed, as of the sponsor's last update on 25 Nov 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 25 Nov 2009.