BronchiolitisPhase 1#9105NCT01065272
Dexamethasone in the Treatment of Bronchiolitis in Patients With Either Eczema and or Family History of Asthma
A Phase 1 study testing Dexamethasone in people with Bronchiolitis, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The investigators hypothesized that oral Dexamethasone in addition to nebulized Salbutamol will improve the Bronchiolitis Clinical Severity Score,duration of treatment in the short stay unit,need for hospitalization and readmissions to the pediatric emergency in a subgroup of patients diagnosed as Bronchiolitis with… Read more about this study
- Who is it for?
- Ages 4 weeks to 18 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteQatar
- Study dates
- Feb 2010to Aug 2012
- Phase
- Phase 1
- 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 4 weeks to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant's ≥ 4weeks and ≤ 18 month.
- First time wheezers.
- Bronchiolitis clinical severity score ≥ 4.
- History of eczema in the patient.
- Parenteral history of asthma
- Sibling history of asthma
Who cannot join
- Prematurity (Gestational age 34 weeks or less).
- Previous history of wheezing episode.
- Use of steroids within the last 48 hours.
- Critically ill patients with one or more of the following:
- Obtunded consciousness,
- Progressive respiratory failure requiring PICU admission.
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- History of apnea.
- Oxygen saturation less than 85%.
- Chronic lung disease of prematurity.
- Cystic fibrosis.
- Congenital heart disease.
- Immunodeficiency.
- Exposure to Varicella within 21 days before enrollment.
Trial locations and contacts
1 site in 1 country.
Qatar1 site
Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.
Doha, Baladiyat ad Dawhah, 3050
About this study
Official title: Dexamethasone Versus Placebo in the Treatment of Viral Bronchiolitis in Patients With Either Eczema and or Parental or Sibling History of Asthma.A Randomized Controlled Trial.
The investigators hypothesized that oral Dexamethasone in addition to nebulized Salbutamol will improve the Bronchiolitis Clinical Severity Score,duration of treatment in the short stay unit,need for hospitalization and readmissions to the pediatric emergency in a subgroup of patients diagnosed as Bronchiolitis with either eczema and or a parental or sibling history of Asthma.
Two groups randomized will be given Nebulized Ventolin plus either oral Dexamethasone or placebo for 5 days.
Read more
Bronchiolitis severity score plus vital signs will be recorded regularly until patient is fit for discharge.
Patients will be discharged on Ventolin inhaler and to complete the five days course of oral Dexamethasone Patients will be followed up for 7 days post discharge by telephone.
Read the detailed description
This is a prospective, randomized, double blinded controlled study. It will be conducted in the main Pediatric Emergency Centre in Qatar(Al- Saad),during the period of Jan 2010 - April 2012.
The study has been approval by the Institution Research Board. The sample size will be 200 patients.100 patients in each arm.
Patients triaged as moderate to severe bronchiolitis will be evaluated and eligible patients are admitted to short stay unit and managed as usual. History and full physical examination will be done by the attending physician and the nurse will check 02 sat., respiratory rate and pulse rate.
The Bronchiolitis clinical severity score will be assessed and then guardians of eligible patients will be approached explaining the purpose and treatment modalities.
Patients will be included after obtaining a verbal and written consent. A CXR and an RSV test will be done for all study patients upon recruitment. The attending physician will complete the data collection sheet A computer generated randomization code will be prepared by the statistician. A pharmacist will prepare the study medications and the placebo. Patients will be randomized to either one of the two treatments:- Ventolin-Dexamethasone group: Oral Dexamethasone 1mg/kg will be given for the first day and then 0.6mg/kg for the next 4 days in addition to the Ventolin nebulizations.
Ventolin-Placebo group: Oral Placebo with a volume equivalent to that of Dexamethasone will be given for the first day and then for the next 4 days in addition to the Ventolin nebulizations.
Nebulized Ventolin 0.5ml in 2 ml Normal Saline will also be given at 0, 30, 60, 120 and 180 minutes and then every 2hours.
Bronchiolitis severity score and O2 saturation will be recorded at enrollment, then after 4,6 and 12hours then every 12 hourly until discharged.
To give additional Ventolin nebulization will be decided clinically as per the discretion of the treating physician and will be recorded.
Nebulized epinephrine will not be used except if the patient is severely distressed. Nebulized Epinephrine 0.5 mg/kg (max 5mg/dose) mixed in 3ml normal saline will be allowed for severely distressed patients as an add on therapy given on PRN basis..
Additional interventions such as Oxygen therapy, Intravenous fluids and PRN nebulized Epinephrine will be recorded as additional therapies.
Patients fit for discharge will have their nebulization stopped \& date, time documented.
Physician will discharge patients based on clinical grounds as not needing supplemental oxygen,minimal or no chest recessions,minimal wheezing or crackles and feeding adequately Patients will be sent home on Ventolin inhaler 2 puffs q 4 hours for 48 hours Then 2 puffs every 4 hours when needed plus the study medication syrup to complete 5days course.
Follow up for one-week post discharge by a phone call daily will be conducted and patients will be assessed in PEC when needed.
- Conditions
- Bronchiolitis
- Being tested
- Dexamethasone, Placebo
- Keywords
- Dexamethasone, Bronchiolitis
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Steroids
0.5 ml Salbutamol in 2 ml normal saline is given at 0,30,60,120,180 minutes and then every 2 hourly till discharge.
1mg/kg of oral Dexamethasone with cherry flavour is also given in the first day, then 0.6 mg/kg/day for 4 days
PlaceboDrug
Also called normal saline plus cherry flavour
0.5 ml Salbutamol in 2 ml normal saline is given at 0,30,60,120,180 minutes and then every 2 hourly till discharge.
1mg/kg of oral Placebo is also given in the first day, then 0.6 mg/kg/day for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Ventolin - Dexamethasone group | Active comparator | Ventolin nebulization with normal saline is given at 0,30,60,120 and 180 minutes,then every 2 hourly. Oral Dexamethasone is also given daily for 5 days. Receives: Drug: Dexamethasone |
| Ventolin - Placebo group | Placebo comparator | Ventolin nebulization with normal saline is given at 0,30,60,120 and 180 minutes,then every 2 hourly. Oral Placebo is also given daily for 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients diagnosed as bronchiolitis were discharged at 12 hours for each group
Measured: 12 hours
Secondary outcomes (1)
Patients diagnosed as bronchiolitis were discharged at 18, 24 , 36 and 48 hours for each group
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khalid M Al-Ansari, FRCPC,FAAP, Principal investigator, Hamad Medical Corporation, Weill Cornell Medical College, Doha-Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065272
- Sponsor's protocol ID
- #9105/09
- Other IDs
- #9105/09
- Acronym
- #9105
- Status last verified
- Sep 2012
- First submitted
- 12 Jan 2010
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Versus Placebo in the Treatment of Viral Bronchiolitis in Patients With Either Eczema and or Parental or Sibling History of Asthma.A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01065272
- Acronym / sponsor ID
- #9105 / #9105/09
- Conditions
- Bronchiolitis
- Keywords
- Dexamethasone, Bronchiolitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Feb 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.
The investigators hypothesized that oral Dexamethasone in addition to nebulized Salbutamol will improve the Bronchiolitis Clinical Severity Score,duration of treatment in the short stay unit,need for hospitalization and readmissions to the pediatric emergency in a subgroup of patients diagnosed as Bronchiolitis with either eczema and or a parental or sibling history of Asthma.
Two groups randomized will be given Nebulized Ventolin plus either oral Dexamethasone or placebo for 5 days.
Bronchiolitis severity score plus vital signs will be recorded regularly until patient is fit for discharge.
Patients will be discharged on Ventolin inhaler and to complete the five days course of oral Dexamethasone Patients will be followed up for 7 days post discharge by telephone.
Detailed description
This is a prospective, randomized, double blinded controlled study. It will be conducted in the main Pediatric Emergency Centre in Qatar(Al- Saad),during the period of Jan 2010 - April 2012.
The study has been approval by the Institution Research Board. The sample size will be 200 patients.100 patients in each arm.
Patients triaged as moderate to severe bronchiolitis will be evaluated and eligible patients are admitted to short stay unit and managed as usual. History and full physical examination will be done by the attending physician and the nurse will check 02 sat., respiratory rate and pulse rate.
The Bronchiolitis clinical severity score will be assessed and then guardians of eligible patients will be approached explaining the purpose and treatment modalities.
Patients will be included after obtaining a verbal and written consent. A CXR and an RSV test will be done for all study patients upon recruitment. The attending physician will complete the data collection sheet A computer generated randomization code will be prepared by the statistician. A pharmacist will prepare the study medications and the placebo. Patients will be randomized to either one of the two treatments:- Ventolin-Dexamethasone group: Oral Dexamethasone 1mg/kg will be given for the first day and then 0.6mg/kg for the next 4 days in addition to the Ventolin nebulizations.
Ventolin-Placebo group: Oral Placebo with a volume equivalent to that of Dexamethasone will be given for the first day and then for the next 4 days in addition to the Ventolin nebulizations.
Nebulized Ventolin 0.5ml in 2 ml Normal Saline will also be given at 0, 30, 60, 120 and 180 minutes and then every 2hours.
Bronchiolitis severity score and O2 saturation will be recorded at enrollment, then after 4,6 and 12hours then every 12 hourly until discharged.
To give additional Ventolin nebulization will be decided clinically as per the discretion of the treating physician and will be recorded.
Nebulized epinephrine will not be used except if the patient is severely distressed. Nebulized Epinephrine 0.5 mg/kg (max 5mg/dose) mixed in 3ml normal saline will be allowed for severely distressed patients as an add on therapy given on PRN basis..
Additional interventions such as Oxygen therapy, Intravenous fluids and PRN nebulized Epinephrine will be recorded as additional therapies.
Patients fit for discharge will have their nebulization stopped \& date, time documented.
Physician will discharge patients based on clinical grounds as not needing supplemental oxygen,minimal or no chest recessions,minimal wheezing or crackles and feeding adequately Patients will be sent home on Ventolin inhaler 2 puffs q 4 hours for 48 hours Then 2 puffs every 4 hours when needed plus the study medication syrup to complete 5days course.
Follow up for one-week post discharge by a phone call daily will be conducted and patients will be assessed in PEC when needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventolin - Dexamethasone group | Active comparator | Drug: DexamethasoneVentolin nebulization with normal saline is given at 0,30,60,120 and 180 minutes,then every 2 hourly. Oral Dexamethasone is also given daily for 5 days. |
| Ventolin - Placebo group | Placebo comparator | Drug: PlaceboVentolin nebulization with normal saline is given at 0,30,60,120 and 180 minutes,then every 2 hourly. Oral Placebo is also given daily for 5 days. |
Who may qualify
- Ages
- 4 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infant's ≥ 4weeks and ≤ 18 month.
- First time wheezers.
- Bronchiolitis clinical severity score ≥ 4.
- History of eczema in the patient.
- Parenteral history of asthma
Key exclusion criteria (13 listed)
- Prematurity (Gestational age 34 weeks or less).
- Previous history of wheezing episode.
- Use of steroids within the last 48 hours.
- Critically ill patients with one or more of the following:
- Chronic lung disease of prematurity.
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 |
|---|---|---|
| DexamethasoneAlso: Steroids0.5 ml Salbutamol in 2 ml normal saline is given at 0,30,60,120,180 minutes and then every 2 hourly till discharge. 1mg/kg of oral Dexamethasone with cherry flavour is also given in the first day, then 0.6 mg/kg/day for 4 days | Drug | Ventolin - Dexamethasone group |
| PlaceboAlso: normal saline plus cherry flavour0.5 ml Salbutamol in 2 ml normal saline is given at 0,30,60,120,180 minutes and then every 2 hourly till discharge. 1mg/kg of oral Placebo is also given in the first day, then 0.6 mg/kg/day for 4 days | Drug | Ventolin - Placebo group |
Primary outcome
Patients diagnosed as bronchiolitis were discharged at 12 hours for each group
Time frame: 12 hours
1 secondary outcome
Patients diagnosed as bronchiolitis were discharged at 18, 24 , 36 and 48 hours for each group
Time frame: 48 hours
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 10 Aug 2016.
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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.
Khalid M Al-Ansari, FRCPC,FAAP principal investigator
Hamad Medical Corporation, Weill Cornell Medical College, Doha-Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone in people with Bronchiolitis, run by Hamad Medical Corporation at 1 site in Qatar.
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 6 inclusion and 13 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 10 Aug 2016. 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 Qatar. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Patients diagnosed as bronchiolitis were discharged at 12 hours for each group (time frame: 12 hours). 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 10 Aug 2016.