A 24 Month Observational Study of Infants 3-24 Months, Who Suffer an Acute Episode of Respiratory Infection and Wheezing Illness

Respiratory Tract Infections Clinical Trial

— BIOPA  

Official title:

Respiratory BIOmarkers in Viral Wheezing That Predict Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741322
• Other study ID #: Pro00100494
• Status: Completed
• Start date: December 12, 2018
• Est. completion date: June 16, 2020

Study information

• Verified date: November 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 hospital.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Gender: All
• Age group: 3 Months to 24 Months

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Infection
• Respiratory Sounds
• Respiratory Tract Infections
• Wheezing

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	The Hartwell Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at 24 months
Secondary	Total confirmed Respiratory tract infections as measured by nasal secretion sampling.		Up to 24 months
Secondary	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 at 24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months