Respiratory Tract InfectionsBIOPANCT03741322
A 24 Month Observational Study of Infants 3-24 Months, Who Suffer an Acute Episode of Respiratory Infection and Wheezing Illness
An observational study of Respiratory Tract Infections and Wheezing, run by Duke University at 1 site in United States.
Trial summary
This study will identify infants between the age of 3 and 24 months of age who are experiencing one of their first acute respiratory infections with confirmed wheezing. Infants who are also confirmed to be wheezing and whose caregiver signs consent will be enrolled from a primary care clinic, emergency room or… Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Respiratory Tract Infections, Wheezing
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 16 Jun 2020
- Phase
- Observational
- 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 3 to 24 months
- All sexes
- Child
Study population: Participants will be offered enrollment into the study via Institutional Review Board-approved methods including review of newly hospitalized patients to Duke Children's Hospital, patients seen in the Duke Children's Hospital Emergency Room, and patients seen in a Duke Children's ambulatory clinics. Consent: The study will be explained to the participant and caregiver by trained study staff (Principal Investigator, Co-Investigator, research coordinator or research assistant).
Who may be able to join
- Documented informed consent from legal guardian prior to study procedures
- Age: 3-24 months at the time of visit 1
- Severe lower respiratory wheezing illness confirmed by auscultation requiring hospitalization or acute care (Emergency Department care or unscheduled ambulatory care)
Who cannot join
- No prior hospital admissions for wheezing illnesses
- No prior diagnosis of asthma or Reactive Airways Disease
- More than 1 prior episode of wheezing confirmed by auscultation
- No congenital or chronic disease which would negatively affect the conduct of the study (e.g. childhood cancer, cystic fibrosis, interstitial lung disease, prior aero-digestive surgery)
- No diagnosis of bronchopulmonary dysplasia
- No premature birth (gestational age < 32 weeks)
- Daily treatment with a daily asthma controller (e.g. Montelukast, inhaled corticosteroid)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Respiratory BIOmarkers in Viral Wheezing That Predict Asthma
This study will identify infants between the age of 3 and 24 months of age who are experiencing one of their first acute respiratory infections with confirmed wheezing. Infants who are also confirmed to be wheezing and whose caregiver signs consent will be enrolled from a primary care clinic, emergency room or hospital.
Read the detailed description
BACKGROUND: Respiratory virus infections are extremely common in young children. These infections typically lead to inflammation and constriction of the airways, which is termed bronchiolitis. Bronchiolitis is the leading cause of hospitalization for infants with respiratory infections, with an average of 120,000 children under the age of one hospitalized every year. Viral infection by Respiratory Syncytial Virus (RSV), rhinoviruses, or influenza viruses is thought to be by far the major driver of bronchiolitis. The children who need to be hospitalized with bronchiolitis have a drastically increased chance (about 45%) of developing chronic respiratory diseases such as wheezing or asthma. The disease of asthma affects children more than adults, and the Centers For Disease Control states that asthma is the most chronic condition among children under the age of 18, affecting more than 6 million (or 8.4%) children in the US. Due to this prevalence, asthma is the third leading cause of hospitalization among children under the age of 15 years, with the annual direct healthcare costs at ~$50 billion every year. The economic costs associated with parental lost productivity is another ~$6 billion every year. The American Lung Association states that asthma is also one of the leading causes of school absenteeism, with an estimated 13.8 million lost school days every year. While asthma can be managed with bronchodilator inhalers, there is not a single treatment designed to prevent or reverse asthma disease. Understanding how viral infection causes initial bronchiolitis and maintains the chronic inflammation that leads to asthma will lead to new treatments that prevent or reverse chronic lung diseases. This research has the potential to change everyday life for millions of children and their families in the US.
- Conditions
- Respiratory Tract Infections, Wheezing
- Medical subject headings
- Respiratory Tract Infections, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants ages 3-24 months with respiratory infections | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Asthma Phenotype (PAP)
Participants will be assessed for meeting criteria for the persistent asthma phenotype which will be defined as meeting any Asthma Predicative Indices plus abnormal lung pulmonary function testing by Impulse oscillometry (either from peripheral airway resistance or bronchodilator responsiveness).
Measured: Measured at 24 months
Secondary outcomes (5)
Total confirmed Respiratory tract infections as measured by nasal secretion sampling.
Measured: Up to 24 months
Pulmonary Function Testing (iPFT)
Impulse Oscillometry (IOS) simply requires the child to breathe in and out through a mouthpiece for 20-30 seconds. During breathing, a loudspeaker delivers a quiet pulse-shaped pressure-flow signal to the respiratory system. The overall respiratory system impedance (Z) is measured and reflects the resistive and viscoelastic forces of the respiratory system determined from the returning signal. Outcome data are reported as respiratory system resistance (R) and reactance (X) measured in centimeters of water per liter per second. Measurements from the 3 efforts for each outcome parameter will be averaged for the final result.
Measured: Measured at 24 months
Presence or absence of Loose Asthma Predictive Indices
Lose API is based on based on any wheezing in first 3 years of life plus, One of the following two: Parental asthma or child eczema, AND Two of the following three: eosinophilia, wheezing without colds, and allergic rhinitis.
Measured: 24 months
Presence or absence of Strict Criteria for API
Strict API is measured based on Early Frequent wheezing in first 3 years of life plus, One of the following two: Parental asthma or child eczema, AND Two of the following three: eosinophilia, wheezing without colds, and allergic rhinitis.
Measured: 24 months
Presence or absence of Modified API
Modified API is measured based on ≥4 wheezing episodes in a year plus, One of the following two: Parental asthma or child eczema or allergic sensitization to at least one aeroallergen, AND Two of the following three: eosinophilia, wheezing without colds, and allergic sensitization to milk, egg or peanuts.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start12 Dec 2018
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Duke 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hartwell Foundation
- Responsible party
- Sponsor
- Investigators
- Jason Lang, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741322
- Sponsor's protocol ID
- Pro00100494
- Acronym
- BIOPA
- Status last verified
- Nov 2020
- First submitted
- 25 Oct 2018
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory BIOmarkers in Viral Wheezing That Predict Asthma
- ClinicalTrials.gov ID
- NCT03741322
- Acronym / sponsor ID
- BIOPA / Pro00100494
- Conditions
- Respiratory Tract Infections, Wheezing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Hartwell Foundation
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 14 Nov 2018 (actual)
- 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 study will identify infants between the age of 3 and 24 months of age who are experiencing one of their first acute respiratory infections with confirmed wheezing. Infants who are also confirmed to be wheezing and whose caregiver signs consent will be enrolled from a primary care clinic, emergency room or hospital.
Detailed description
BACKGROUND: Respiratory virus infections are extremely common in young children. These infections typically lead to inflammation and constriction of the airways, which is termed bronchiolitis. Bronchiolitis is the leading cause of hospitalization for infants with respiratory infections, with an average of 120,000 children under the age of one hospitalized every year. Viral infection by Respiratory Syncytial Virus (RSV), rhinoviruses, or influenza viruses is thought to be by far the major driver of bronchiolitis. The children who need to be hospitalized with bronchiolitis have a drastically increased chance (about 45%) of developing chronic respiratory diseases such as wheezing or asthma. The disease of asthma affects children more than adults, and the Centers For Disease Control states that asthma is the most chronic condition among children under the age of 18, affecting more than 6 million (or 8.4%) children in the US. Due to this prevalence, asthma is the third leading cause of hospitalization among children under the age of 15 years, with the annual direct healthcare costs at ~$50 billion every year. The economic costs associated with parental lost productivity is another ~$6 billion every year. The American Lung Association states that asthma is also one of the leading causes of school absenteeism, with an estimated 13.8 million lost school days every year. While asthma can be managed with bronchodilator inhalers, there is not a single treatment designed to prevent or reverse asthma disease. Understanding how viral infection causes initial bronchiolitis and maintains the chronic inflammation that leads to asthma will lead to new treatments that prevent or reverse chronic lung diseases. This research has the potential to change everyday life for millions of children and their families in the US.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants ages 3-24 months with respiratory infections | – | – |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Age groups
- Child
- Study population
- Participants will be offered enrollment into the study via Institutional Review Board-approved methods including review of newly hospitalized patients to Duke Children's Hospital, patients seen in the Duke Children's Hospital Emergency Room, and patients seen in a Duke Children's ambulatory clinics. Consent: The study will be explained to the participant and caregiver by trained study staff (Principal Investigator, Co-Investigator, research coordinator or research assistant).
Key inclusion criteria (3 listed)
- Documented informed consent from legal guardian prior to study procedures
- Age: 3-24 months at the time of visit 1
- Severe lower respiratory wheezing illness confirmed by auscultation requiring hospitalization or acute care (Emergency Department care or unscheduled ambulatory care)
Key exclusion criteria (7 listed)
- No prior hospital admissions for wheezing illnesses
- No prior diagnosis of asthma or Reactive Airways Disease
- More than 1 prior episode of wheezing confirmed by auscultation
- No congenital or chronic disease which would negatively affect the conduct of the study (e.g. childhood cancer, cystic fibrosis, interstitial lung disease, prior aero-digestive surgery)
- No diagnosis of bronchopulmonary dysplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistent Asthma Phenotype (PAP)
Time frame: Measured at 24 months
Participants will be assessed for meeting criteria for the persistent asthma phenotype which will be defined as meeting any Asthma Predicative Indices plus abnormal lung pulmonary function testing by Impulse oscillometry (either from peripheral airway resistance or bronchodilator responsiveness).
5 secondary outcomes
Total confirmed Respiratory tract infections as measured by nasal secretion sampling.
Time frame: Up to 24 months
Pulmonary Function Testing (iPFT)
Time frame: Measured at 24 months
Presence or absence of Loose Asthma Predictive Indices
Time frame: 24 months
Presence or absence of Strict Criteria for API
Time frame: 24 months
Presence or absence of Modified API
Time frame: 24 months
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 25 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Jason Lang, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections and Wheezing, run by Duke 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 3 inclusion and 7 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 25 Nov 2020. 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?
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?
Persistent Asthma Phenotype (PAP) (time frame: Measured at 24 months). 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 25 Nov 2020.