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ORBEX Study

University of North Carolina at Chapel Hill


Description

The primary objective of this study is to evaluate if the study drug when given to infants (6-18 months who are at a higher risk of developing asthma) for 10 days monthly for two consecutive treatment years can increase the time to the occurrence of the first wheezing episode during a third observation year while off of study drug therapy.


Keywords:

Asthma, Pediatrics


Category:

Drug or Biologic
Phase:2

Qualifications

 


Age
0 - 0 years


Gender
Any


Study Population

• Age: 6-18 months of age inclusive at randomization. At least half of all enrolled children will be between 6 and 12 months of age at randomization. • Participants will meet at least one of the following criteria, which have been associated with an increased risk of WLRI and asthma: a) Parental history of asthma -or- b) Physician-diagnosed atopic dermatitis in the participant - or- c) Physician-diagnosed asthma in a blood sibling aged 4 years or more. • Participants may be either male or female. • Participants will have least one parent/guardian who can communicate with the study staff to allow assessment of study outcomes. • The child's parent/guardian must have a working direct contact telephone.


Investigator

Stephanie Davis
Distinguished Professor
Pediatrics - Pulmonology

For questions, contact:

Rita Bowden RN, CCRC
rita24@email.unc.edu
(919) 843-1577


Recruitment Period End

September 7, 2020

Location

Primary Location
Clinical & Translational Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 0 - 0 years

Participant qualification(s) 1) Parental history of asthma. 2) Physician diagnosed atopic dermatitis in the participant. 3) Physician diagnosed asthma in a blood sibling aged 4 years or older.

Not eligible if: Participant may not have a physician's diagnosis of asthma.

Number of Visits

    » 12 In person visit(s)

    12 clinic visits.

    » 26 Remote visit(s)

    Completed by phone call or by text.

Participation Period

3 years

Compensation

$70 for each of the 12 clinic visits and $20 for each of the 26 completed phone calls.

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.