AsthmaPhase 4NCT00733473
Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
A Phase 4 study testing Budesonide 0.5 mg/ml nebules and % 0.9 Saline solution in people with Asthma and Acute Asthma, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in children who have hospitalized for acute wheezing. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Asthma, Acute Asthma
- What is being tested?
- Budesonide 0.5 mg/ml nebules and % 0.9 Saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2007to Jan 2010
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who have recurrent wheezing attacks
- Children who admitted to the hospital for acute wheezing
- Clinical asthma score of 3-9
- Parental/guardian permission (informed consent) and if appropriate, child assent
Who cannot join
- Systemic corticosteroid use in the last 30 days
- Chronic lung diseases including cystic fibrosis
- Immunodeficiency
- Cardiac disease requiring surgery or medications
- Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
- Known renal or hepatic dysfunction
Show all 11Show fewer
- Impending respiratory failure requiring positive pressure ventilation
- Immune deficiency
- Gastroesophageal reflux disease
- Suspected foreign body aspiration or croup
- Anatomic abnormalities of the respiratory tract
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kecioren Education and Training Hospital
Ankara, Kecioren, 06380
About this study
Official title: Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in children who have hospitalized for acute wheezing.
Read the detailed description
Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids.
Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in hospitalized children has any benefit on, symptom score, duration of hospitalization and time to discharge from hospital.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the hospital for acute wheezing.
Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.
Study Measures: Differences in asthma scores, vital signs, duration of hospitalization and time to discharge from hospital will be compared between treatment groups.
- Conditions
- Asthma, Acute Asthma
- Being tested
- Budesonide 0.5 mg/ml nebules, % 0.9 Saline solution
- Keywords
- Wheezing, Acute asthma, Children
- Medical subject headings
- Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide 0.5 mg/ml nebulesDrug
Also called Pulmicort 0.5 mg/ml nebules
Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
% 0.9 Saline solutionDrug
Children will receive 2 ml of nebulized saline 2 times a day up to 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 Budesonide | Active comparator | This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 1 mg nebulized budesonide 2 times a day upto 5 days Receives: Drug: Budesonide 0.5 mg/ml nebules |
| 2 Placebo saline | Placebo comparator | This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 2ml of nebulized saline 2 times a day upto 5 days Receives: Drug: % 0.9 Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge from the hospital to home
Measured: 1-5 days
Secondary outcomes (4)
Pulmonary index score
Measured: 1 to 5 days
Respiratory rate
Measured: 1 to 5 days
Oxygen saturation
Measured: 1 to 5 days
Adverse reactions.
Measured: 1 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionJan 2010
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cem Hasan Razi, Kecioren Education and Training Hospital
- Investigators
- C H Razi, MD, Study director, Kecioren Education and Training HospitalC H Razi, MD, Principal investigator, Kecioren Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733473
- Sponsor's protocol ID
- B.10.0.İEG.0.11.00.01-3246
- Status last verified
- Dec 2011
- First submitted
- 12 Aug 2008
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
- ClinicalTrials.gov ID
- NCT00733473
- Acronym / sponsor ID
- B.10.0.İEG.0.11.00.01-3246
- Conditions
- Asthma, Acute Asthma
- Keywords
- Wheezing, Acute asthma, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Aug 2008 (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.
The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in children who have hospitalized for acute wheezing.
Detailed description
Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids.
Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in hospitalized children has any benefit on, symptom score, duration of hospitalization and time to discharge from hospital.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the hospital for acute wheezing.
Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.
Study Measures: Differences in asthma scores, vital signs, duration of hospitalization and time to discharge from hospital will be compared between treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Budesonide | Active comparator | Drug: Budesonide 0.5 mg/ml nebulesThis arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 1 mg nebulized budesonide 2 times a day upto 5 days |
| 2 Placebo saline | Placebo comparator | Drug: % 0.9 Saline solutionThis arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 2ml of nebulized saline 2 times a day upto 5 days |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who have recurrent wheezing attacks
- Children who admitted to the hospital for acute wheezing
- Clinical asthma score of 3-9
- Parental/guardian permission (informed consent) and if appropriate, child assent
Key exclusion criteria (11 listed)
- Systemic corticosteroid use in the last 30 days
- Chronic lung diseases including cystic fibrosis
- Immunodeficiency
- Cardiac disease requiring surgery or medications
- Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
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 0.5 mg/ml nebulesAlso: Pulmicort 0.5 mg/ml nebulesChildren will receive 1 mg nebulized budesonide 2 times a day up to 5 days | Drug | 1 Budesonide |
| % 0.9 Saline solutionChildren will receive 2 ml of nebulized saline 2 times a day up to 5 days | Drug | 2 Placebo saline |
Primary outcome
Time to discharge from the hospital to home
Time frame: 1-5 days
4 secondary outcomes
Pulmonary index score
Time frame: 1 to 5 days
Respiratory rate
Time frame: 1 to 5 days
Oxygen saturation
Time frame: 1 to 5 days
Adverse reactions.
Time frame: 1 to 5 days
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 20 Dec 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.
C H Razi, MD study director
Kecioren Education and Training Hospital
C H Razi, MD principal investigator
Kecioren Education and Training Hospital
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 Budesonide 0.5 mg/ml nebules and % 0.9 Saline solution in people with Asthma and Acute Asthma, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 11 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 20 Dec 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
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?
Time to discharge from the hospital to home (time frame: 1-5 days). 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 20 Dec 2011.