Asthma ExacerbationNCT01179152
Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic
A study testing Budesonide turbuhaler, Budesonide+Formoterol turbuhaler in people with Asthma Exacerbation, run by Meir Medical Center at 1 site in Israel.
Trial summary
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma Exacerbation
- What is being tested?
- Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Oct 2012
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009
- -
Who cannot join
- any chronic condition that can involve respiratory tract (other than asthma) treated as prevention with ICS or montelukast from July 2010 Treated with oral steroids during the August 2010 asthma exacerbation one week prior study inclusion
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Avner He Cohen, MD
About this study
Official title: Childhood Asthma and Return to School: the September Epidemic Exacerbation in Israel.A Controlled Trial of the Effectiveness of Preventive Treatment With Symbicort or Budicort Turbuhaler
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.
Read the detailed description
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.
We will study the effectiveness of Budicort or Symbicort turbuhaler as a preventive treatment in children aged 6-18 years.
- Conditions
- Asthma Exacerbation
- Being tested
- Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
- Keywords
- asthma, september epidemic, children, preventive
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide turbuhaler, Budesonide+Formoterol turbuhalerDrug
Also called Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler
| Study group | Role | What they receive |
|---|---|---|
| Budicort | Active comparator | 75 children will receive treatment with Budicort 200 mcg Receives: Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler |
| Symbicort | Active comparator | 75 children will receive treatment with Symbicort 160 mcg Receives: Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler |
| counselling | No intervention | 75 children who will not treated as their request but will be folowedup Receives: Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of asthma exacerbation during the study period
less asthma exacerbation
Measured: An average time of 8 weeks
Secondary outcomes (1)
less primary care physician visits
less primary care physician visits less ER visits less hospitalization due to asthma exacerbation
Measured: An average time of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma ExacerbationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avner He Cohen, Dr, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179152
- Sponsor's protocol ID
- hermanasthma
- Status last verified
- Mar 2012
- First submitted
- 9 Aug 2010
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnston NJ, Johnston SL, Duncan JM, Greene JM,Keith PK,Roy M, Wsaerman S, Sears MR. The september epidemic of asthma exacerbation in children:a search for etiology. J allergy Clin Immunol 2005,115;132-8 Scheuerman O, Meyerowitch J, Marcus N, Hoffer V, Batt E , Garty B-Z. The september epidemic of asthma in Israel. J of Asthma 2009;46;652-5 Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM,Lambert K, Sears Mr. Attenuation of the september epidemic of asthma exacerbation in children: A randomized controlled trial of montelukast added to usual therapy. Pediatrics;120;e702-e712.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Asthma and Return to School: the September Epidemic Exacerbation in Israel.A Controlled Trial of the Effectiveness of Preventive Treatment With Symbicort or Budicort Turbuhaler
- ClinicalTrials.gov ID
- NCT01179152
- Acronym / sponsor ID
- hermanasthma
- Conditions
- Asthma Exacerbation
- Keywords
- asthma, september epidemic, children, preventive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (estimated)
- First posted
- 11 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.
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.
Detailed description
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.
We will study the effectiveness of Budicort or Symbicort turbuhaler as a preventive treatment in children aged 6-18 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Budicort | Active comparator | Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler75 children will receive treatment with Budicort 200 mcg |
| Symbicort | Active comparator | Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler75 children will receive treatment with Symbicort 160 mcg |
| counselling | No intervention | Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler75 children who will not treated as their request but will be folowedup |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009
- -
Key exclusion criteria (1 listed)
- any chronic condition that can involve respiratory tract (other than asthma) treated as prevention with ICS or montelukast from July 2010 Treated with oral steroids during the August 2010 asthma exacerbation one week prior study inclusion
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 |
|---|---|---|
| Budesonide turbuhaler, Budesonide+Formoterol turbuhalerAlso: Budesonide turbuhaler, Budesonide+Formoterol turbuhalerBudesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler | Drug | Budicort, Symbicort, counselling |
Primary outcome
reduction of asthma exacerbation during the study period
Time frame: An average time of 8 weeks
less asthma exacerbation
1 secondary outcome
less primary care physician visits
Time frame: An average time of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- BackgroundJohnston NJ, Johnston SL, Duncan JM, Greene JM,Keith PK,Roy M, Wsaerman S, Sears MR. The september epidemic of asthma exacerbation in children:a search for etiology. J allergy Clin Immunol 2005,115;132-8 Scheuerman O, Meyerowitch J, Marcus N, Hoffer V, Batt E , Garty B-Z. The september epidemic of asthma in Israel. J of Asthma 2009;46;652-5 Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM,Lambert K, Sears Mr. Attenuation of the september epidemic of asthma exacerbation in children: A randomized controlled trial of montelukast added to usual therapy. Pediatrics;120;e702-e712.
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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.
Avner He Cohen, Dr principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide turbuhaler, Budesonide+Formoterol turbuhaler in people with Asthma Exacerbation, run by Meir 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: status not confirmed, as of the sponsor's last update on 19 Mar 2012. 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?
Contact Avner He Cohen, MD (972-3-9398200, hermanc@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of asthma exacerbation during the study period (time frame: An average time of 8 weeks). 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 NCT01179152, 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 19 Mar 2012.