Preventing Asthma in High Risk Kids

Asthma Clinical Trial

— PARK  

Official title:

Controlling and Preventing Asthma Progression and Severity in Kids

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02570984
• Other study ID #: IRB-P00019640
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 27, 2018
• Est. completion date: March 31, 2028

Study information

• Verified date: February 2024
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.

Description:

Prevention/ Disease modification of asthma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 47 Months

Eligibility

Inclusion Criteria:

1. Parent/guardian must be able to understand and provide signed and dated written informed consent; he/she must also be able to communicate with study staff.

2. 24-47 months of age at randomization

3. 2-4 wheezing episodes in the past year

4. positive allergy to aeroallergen

5. first degree relative with history or current diagnosis of asthma or allergy

6. If is participating in a food immunotherapy treatment that is not part of a clinical trial, has been on an established maintenance regimen implemented continuously for a minimum of 2 months.

Exclusion Criteria:

1. >4 episodes of wheezing in the past year

2. Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0).

3. Need for systemic corticosteroids or a hospitalization for respiratory symptoms within four weeks prior to screening.

4. Three or more courses of systemic corticosteroids for wheezing illnesses in the last year

5. More than four days of symptoms of wheezing, or tightness in the chest or cough in the past two weeks causing at least minimal limitation of activity

6. More than four days of albuterol treatment (for symptoms) in the past two weeks

7. More than one night of symptoms of wheezing, or tightness in the chest or cough causing sleep disruption in the past two weeks

8. More than one night of albuterol treatment (for symptoms) in the past two weeks

9. Prematurity (<34 weeks gestation)

10. Need for oxygen for more than 5 days in the neonatal period

11. History of intubation or mechanical ventilation for respiratory illness

12. Other significant medical conditions, including: major congenital anomalies, cystic fibrosis, chronic pulmonary diseases, bronchopulmonary dysplasia, thoracic surgery, history of tuberculosis, immunodeficiency (primary or secondary), seizure disorders

13. Expecting to relocate within 4 years of study initiation to a place which would make in-person clinical visits impossible

14. Deemed unable to adhere to study activities

15. Prior aeroallergen immunotherapy or use of biologics including anti-IgE

16. Prior IVIG or systemic immunosuppressant other than corticosteroids

17. History of hypoxic seizures during a wheezing episode

18. Total IgE outside of the omalizumab dosing range.

19. Enrolled in any clinical medication trial within the past 30 days.

20. With platelet counts < 150 x 109/L at the Screening Visit (V0)

21. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study.

22. History of severe anaphylactic/anaphylactoid reactions from any cause

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Omalizumab
anti-ige injection
• Placebo
placebo comparator arm, injection similar to active

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Childrens Hospital Colorado	Aurora	Colorado
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Connecticut Children's Hospital	Hartford	Connecticut
United States	Texas Children's Hospital/Baylor College of Medicine	Houston	Texas
United States	Indiana University/Riley Children's Hospital	Indianapolis	Indiana
United States	University of Wisconsin	Madison	Wisconsin
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Washington University	Saint Louis	Missouri
United States	Rady Children's Hospital - San Diego	San Diego	California
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	active asthma diagnosis	questionnaire	Final 12 months during 2 year observation period off study drug
Primary	asthma severity	questionnaire	Final 12 months during 2 year observation period off study drug
Secondary	number of positive new allergic sensitization	skin prick test	Final 12 months during 2 year observation period off study drug
Secondary	decrease in number of wheezing episodes	questionnaires	Final 12 months during 2 year observation period off study drug