BronchiolitisNCT00622817
The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
A study testing xylometazoline HCL 0.05% and Epinephrine 1mg in people with Bronchiolitis, run by Schneider Children's Medical Center, Israel.
Trial summary
This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis. The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- xylometazoline HCL 0.05% and Epinephrine 1mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Mar 2005
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full term previously healthy Infants
- Ages 1-12 months
- After informed consent was signed with clinical presentation of mild to moderate bronchiolitis
Who cannot join
- Prematurity, congenital lung or cardiac disease
- Infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score >7 with a range scale 0-10)
About this study
Official title: Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis
This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis.
The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis.
Read more
Signed informed consent was obtained from a parent of each child. And the human ethics committee of our hospital approved the study according to the principles of the Declaration of Helsinki.(Approved - 2002)
Patients:
65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider Children's Medical Center because of bronchiolitis during winter in two consecutive years 2004-2005.
The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after informed consent was signed with clinical presentation of mild to moderate bronchiolitis according to a clinical score .Exclusion criteria were as follows: prematurity, congenital lung or cardiac disease, infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score>7 with a range scale 0-10).
Read the detailed description
All eligible patients were randomly assigned to one of two groups: Group 1 (control) received inhalation of epinephrine 1mg, in 2cc of 0.9% saline solution four times a day, and nasal drops of 0.9% saline for each nostril every twelve hours. Group 2 - the study group received four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL to each nostril twice a day. This treatment continued until the patient was ready for discharge.
Patients were examined and evaluated at the study entry and were re-evaluated every 10-12 hours. Length of hospital stay,time to improve Oxygen saturation, time to the need of IV fluid and clinical score between the two groups of treatment were compared.
- Conditions
- Bronchiolitis
- Being tested
- xylometazoline HCL 0.05%, Epinephrine 1mg
- Keywords
- Epinephrine, Nasal decongestant, RSV, xylometazoline, Bronchiolitis
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylometazoline HCL 0.05%Drug
Also called xylometazoline HCL = Otrivin nasal drops
Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.
Epinephrine 1mgDrug
Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours. Receives: Drug: Epinephrine 1mg |
| 2 | Experimental | Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day. Receives: Drug: xylometazoline HCL 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: Two years
Secondary outcomes (1)
Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startOct 2004
- Primary completionMar 2005
- Study completionMar 2005
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 BronchiolitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schneider Children's Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622817
- Sponsor's protocol ID
- 2848
- Status last verified
- Feb 2002
- First submitted
- 14 Feb 2008
- Last updated
- 26 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Livni G, Rachmel A, Marom D, Yaari A, Tirosh N, Ashkenazi S. A randomized, double-blind study examining the comparative efficacies and safety of inhaled epinephrine and nasal decongestant in hospitalized infants with acute bronchiolitis. Pediatr Infect Dis J. 2010 Jan;29(1):71-3. doi: 10.1097/INF.0b013e3181b0602e.
PubMed 19907355
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis
- ClinicalTrials.gov ID
- NCT00622817
- Acronym / sponsor ID
- 2848
- Conditions
- Bronchiolitis
- Keywords
- Epinephrine, Nasal decongestant, RSV, xylometazoline, Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Schneider Children's Medical Center, IsraelUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 25 Feb 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.
This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis.
The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis.
Signed informed consent was obtained from a parent of each child. And the human ethics committee of our hospital approved the study according to the principles of the Declaration of Helsinki.(Approved - 2002)
Patients:
65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider Children's Medical Center because of bronchiolitis during winter in two consecutive years 2004-2005.
The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after informed consent was signed with clinical presentation of mild to moderate bronchiolitis according to a clinical score .Exclusion criteria were as follows: prematurity, congenital lung or cardiac disease, infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score>7 with a range scale 0-10).
Detailed description
All eligible patients were randomly assigned to one of two groups: Group 1 (control) received inhalation of epinephrine 1mg, in 2cc of 0.9% saline solution four times a day, and nasal drops of 0.9% saline for each nostril every twelve hours. Group 2 - the study group received four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL to each nostril twice a day. This treatment continued until the patient was ready for discharge.
Patients were examined and evaluated at the study entry and were re-evaluated every 10-12 hours. Length of hospital stay,time to improve Oxygen saturation, time to the need of IV fluid and clinical score between the two groups of treatment were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Epinephrine 1mgPatients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours. |
| 2 | Experimental | Drug: xylometazoline HCL 0.05%Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full term previously healthy Infants
- Ages 1-12 months
- After informed consent was signed with clinical presentation of mild to moderate bronchiolitis
Key exclusion criteria (2 listed)
- Prematurity, congenital lung or cardiac disease
- Infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score >7 with a range scale 0-10)
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 |
|---|---|---|
| xylometazoline HCL 0.05%Also: xylometazoline HCL = Otrivin nasal dropsReceive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day. | Drug | 2 |
| Epinephrine 1mgPatients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours. | Drug | 1 |
Primary outcome
Length of hospital stay
Time frame: Two years
1 secondary outcome
Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids
Time frame: 2 years
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 26 Feb 2008.
- Derived from this study: PubMed 19907355Livni G, Rachmel A, Marom D, Yaari A, Tirosh N, Ashkenazi S. A randomized, double-blind study examining the comparative efficacies and safety of inhaled epinephrine and nasal decongestant in hospitalized infants with acute bronchiolitis. Pediatr Infect Dis J. 2010 Jan;29(1):71-3. doi: 10.1097/INF.0b013e3181b0602e.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing xylometazoline HCL 0.05% and Epinephrine 1mg in people with Bronchiolitis, run by Schneider Children's Medical Center, 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 3 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: finished, as of the sponsor's last update on 26 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Length of hospital stay (time frame: Two years). 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 NCT00622817, 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 26 Feb 2008.