Asthma ExacerbationPhase 4NCT00397267
Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids
A Phase 4 study testing inhalation of corticosteroids in people with Asthma Exacerbation, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
We assume that the combination of systemic steroids and inhaled steroid in the first hour of treatment in the ER will decrease the admission rate and improve faster the pulmonary function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma Exacerbation
- What is being tested?
- inhalation of corticosteroids
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Dec 2007
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Asthmatic patients aged 18-60 with PFR < 60% of predicted
Who cannot join
- Patients with other chronic diseases
- cardiac renal hepatic etc will be excluded
Trial locations and contacts
1 site in 1 country.
LUNA Avnon, M.D contact
About this study
We assume that the combination of systemic steroids and inhaled steroid in the first hour of treatment in the ER will decrease the admission rate and improve faster the pulmonary function.
120 patients refferd to the ER due to asthma attack aged 18-60 with PFR < 60% 0o predicted will participate in the study after giving informed consent.
The usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each during the first hour.
The controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.
Read the detailed description
Primary end points- PFT improvment and admission rate.
- Conditions
- Asthma Exacerbation
- Being tested
- inhalation of corticosteroids
- Keywords
- Dyspnea, Cough
- Medical subject headings
- Dyspnea, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalation of corticosteroidsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PFT improvment
Admission rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startJan 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Dov Heimer, M.D, Principal investigator, BGU Soroka medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397267
- Sponsor's protocol ID
- SOR440906CTIL
- Status last verified
- Oct 2006
- First submitted
- 8 Nov 2006
- Last updated
- 28 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids
- ClinicalTrials.gov ID
- NCT00397267
- Acronym / sponsor ID
- SOR440906CTIL
- Conditions
- Asthma Exacerbation
- Keywords
- Dyspnea, Cough
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2007
- First posted
- 9 Nov 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.
We assume that the combination of systemic steroids and inhaled steroid in the first hour of treatment in the ER will decrease the admission rate and improve faster the pulmonary function.
120 patients refferd to the ER due to asthma attack aged 18-60 with PFR < 60% 0o predicted will participate in the study after giving informed consent.
The usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each during the first hour.
The controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.
Detailed description
Primary end points- PFT improvment and admission rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Asthmatic patients aged 18-60 with PFR < 60% of predicted
Key exclusion criteria (2 listed)
- Patients with other chronic diseases
- cardiac renal hepatic etc will be excluded
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 |
|---|---|---|
| inhalation of corticosteroids | Drug | – |
Primary outcome
PFT improvment
Admission rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2006.
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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.
LUNA Avnon, M.D contact
Dov Heimer, M.D principal investigator
BGU Soroka 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 inhalation of corticosteroids in people with Asthma Exacerbation, run by Soroka University 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 2 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 28 Nov 2006. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dov Heimer M.D. Heimer, AS. Proffessor (972 8 6400807, heimerd@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFT improvment. 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 28 Nov 2006.