BronchiolitisNCT00435994
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
A study testing Inhaled primatene will be given as a breathing treatment and Nasal Washing in people with Bronchiolitis and Respiratory Syncytial Virus Infections, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. Read more about this study
- Who is it for?
- Ages 2 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis, Respiratory Syncytial Virus Infections
- What is being tested?
- Inhaled primatene will be given as a breathing treatment and Nasal Washing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Group 1 Infants between 2 and 24 months that are healthy
- Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing
Who cannot join
- Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity < 37 weeks, and cannot be in the ICU.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.
Read the detailed description
We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.
- Being tested
- Inhaled primatene will be given as a breathing treatment, Nasal Washing
- Keywords
- Infant, Respiratory Syncytial Virus, Bronchiolitis
- Medical subject headings
- Bronchiolitis, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled primatene will be given as a breathing treatmentDrug
Also called epinephrine 0.5ml of the 2.25% concentration
While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.
Nasal WashingOther
1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence
| Study group | Role | What they receive |
|---|---|---|
| Infants with viral lower respiratory infections | Other | Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants Receives: Drug: Inhaled primatene will be given as a breathing treatment; Other: Nasal Washing |
| Healthy Control | Other | Healthy infants between the ages of 2-24 month Receives: Drug: Inhaled primatene will be given as a breathing treatment; Other: Nasal Washing |
| Bronchiolitis-Nasal wash only | Other | Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only Receives: Other: Nasal Washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Function
Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.
Measured: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)
Endothelial Growth Factor (VEGF)
Analysis for VEGF level by ELISA
Measured: During nasal wash
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startDec 2003
- Primary completionMar 2009
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Robert S. Tepper, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435994
- Sponsor's protocol ID
- 0311-21
- Status last verified
- May 2016
- First submitted
- 25 Jan 2007
- Last updated
- 1 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
- ClinicalTrials.gov ID
- NCT00435994
- Acronym / sponsor ID
- 0311-21
- Keywords
- Infant, Respiratory Syncytial Virus, Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Dec 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Feb 2007 (estimated)
- Results
- Posted 1 Jun 2016
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 evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.
Detailed description
We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infants with viral lower respiratory infections | Other | Drug: Inhaled primatene will be given as a breathing treatment, Other: Nasal WashingInfants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants |
| Healthy Control | Other | Drug: Inhaled primatene will be given as a breathing treatment, Other: Nasal WashingHealthy infants between the ages of 2-24 month |
| Bronchiolitis-Nasal wash only | Other | Other: Nasal WashingInfants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Group 1 Infants between 2 and 24 months that are healthy
- Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing
Key exclusion criteria (1 listed)
- Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity < 37 weeks, and cannot be in the ICU.
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 |
|---|---|---|
| Inhaled primatene will be given as a breathing treatmentAlso: epinephrine 0.5ml of the 2.25% concentrationWhile the research subject is sedated an inhaled mist of primatene mist will be given to the patient. | Drug | Healthy Control, Infants with viral lower respiratory infections |
| Nasal Washing1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence | Other | Bronchiolitis-Nasal wash only, Healthy Control, Infants with viral lower respiratory infections |
Primary outcome
Lung Function
Time frame: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)
Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.
Endothelial Growth Factor (VEGF)
Time frame: During nasal wash
Analysis for VEGF level by ELISA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert S. Tepper, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled primatene will be given as a breathing treatment and Nasal Washing in people with Bronchiolitis and Respiratory Syncytial Virus Infections, run by Indiana University at 1 site in United States.
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: finished, as of the sponsor's last update on 1 Jun 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lung Function (time frame: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)). 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 1 Jun 2016.