Allergy Immunotherapy for the Reduction of Asthma

NCT01028560 | Completed Phase 1 Results DMC

• 1 other identifier: 2007-280
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing asthma and allergy related disease in children who had multiple episodes of wheezing and who are at high risk for developing persisting asthma. These risks include a history of asthma in the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new and has been practiced for many years to treat asthma and environmental allergies in older children and adults, but has not yet been systematically studied in young children.

Conditions

Wheezing; Asthma; Allergy

Keywords

Wheezing; Asthma; Allergy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months)

  The Asthma Severity Score is a customized score created for this study due to the lack of standardized instruments for this age group. It takes into account asthma symptom severity and frequency, as well as asthma medication dosing and potency. Data was collected at baseline and every 2 weeks through interviews conducted over the phone. If the caregiver could not be reached by the phone, the interview was conducted at the next face-to face opportunity (study or injection visit). The minimum score on this scale is 0 (no asthma symptoms and no asthma medicines used during the 14 day interview period). The maximum score is 224 (uncontrolled severe asthma with severe cough, shortness of breath and wheezing on 14 of 14 days, using Albuterol 2 puffs 4x/day, budesonide/formoterol 160ug/4.5ug 2 puffs twice daily and Montelukast 4mg daily on 14 of 14 days). Scores calculated from the collected data were averaged to produce one reported value at baseline and year 1, 2 and 3.

  baseline and every two weeks up to end of study (up to 36 months)

Secondary Outcomes (3)

• Number of Newly Gained Allergic Sensitizations as Assessed by Serum Specific Immunoglobulin E (IgE) Testing

  Baseline and end of treatment (36 months)

• Peripheral Blood T Regulatory Cells as a Percentage of CD4+ (Cluster of Differentiation 4) Cells

  Baseline and every 12 months until end of treatment (36 months)

• Incidence Rate of Systemic Corticosteroid Bursts (CSB) Per Child

  From baseline through end of study (maximum 36 months)

Study Arms (2)

No immunotherapy, receive standard of care asthma treatment

ACTIVE COMPARATOR

This group consists of children who do not receive allergy immunotherapy. Both groups - the experimental as well as the control group receive otherwise standard of care asthma and allergy treatment

Other: Standard of care

Allergen immunotherapy

EXPERIMENTAL

This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment

Biological: Allergen extracts (subcutaneous injections); Other: Standard of care

Interventions

Allergen extracts (subcutaneous injections) BIOLOGICAL

Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-2 injections until a predetermined maintenance dose is reached. This maintenance dose varies by extract and accords to the general practice guidelines of immunotherapy. To increase safety, the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase (year 2-3)

Allergen immunotherapy

Standard of care OTHER

standard of care asthma and allergy treatment

Allergen immunotherapy; No immunotherapy, receive standard of care asthma treatment

Eligibility Criteria

• Age: 18 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment.
• Positive skin tests or specific Immunoglobulin E (IgE) antibody titers to at least one of common airborne allergens: Dust Mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site).
• The child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions OR 2 of the following minor conditions:
• Major criteria: History of atopic dermatitis and/or parental history of asthma.
• Minor criteria: MD-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%.

You may not qualify if:

• The child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant atrial or ventricular septum defect or heart murmur).
• The child was born following 35 or less weeks of gestation.
• Parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth.
• The child fails to thrive, defined as crossing of two major growth percentile lines during the last year.
• The child has chronic lung disease of prematurity (CLDP), cystic fibrosis or any other chronic lung disease.
• The child ever received immunotherapy.
• The child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma).
• History of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Jacobi Medical Center: collaborator

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (6)

• Abramson MJ, Puy RM, Weiner JM. Allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2003;(4):CD001186. doi: 10.1002/14651858.CD001186.

  PMID: 14583928 BACKGROUND

• Roberts G, Hurley C, Turcanu V, Lack G. Grass pollen immunotherapy as an effective therapy for childhood seasonal allergic asthma. J Allergy Clin Immunol. 2006 Feb;117(2):263-8. doi: 10.1016/j.jaci.2005.09.054.

  PMID: 16461125 BACKGROUND

• Pifferi M, Baldini G, Marrazzini G, Baldini M, Ragazzo V, Pietrobelli A, Boner AL. Benefits of immunotherapy with a standardized Dermatophagoides pteronyssinus extract in asthmatic children: a three-year prospective study. Allergy. 2002 Sep;57(9):785-90. doi: 10.1034/j.1398-9995.2002.23498.x.

  PMID: 12169173 BACKGROUND

• de Vos G, Viswanathan S, Pichardo Y, Nazari R, Jorge Y, Ren Z, Serebrisky D, Rosenstreich D, Wiznia A. A randomized trial of subcutaneous allergy immunotherapy in inner-city children with asthma less than 4 years of age. Ann Allergy Asthma Immunol. 2021 Apr;126(4):367-377.e5. doi: 10.1016/j.anai.2020.12.016. Epub 2021 Jan 6.

  PMID: 33418053 DERIVED

• de Vos G, Nazari R, Ferastraoaru D, Parikh P, Geliebter R, Pichardo Y, Wiznia A, Rosenstreich D. Discordance between aeroallergen specific serum IgE and skin testing in children younger than 4 years. Ann Allergy Asthma Immunol. 2013 Jun;110(6):438-43. doi: 10.1016/j.anai.2013.03.006. Epub 2013 Apr 11.

  PMID: 23706713 DERIVED

• de Vos G, Shankar V, Nazari R, Kooragayalu S, Smith M, Wiznia A, Rosenstreich D. Fear of repeated injections in children younger than 4 years receiving subcutaneous allergy immunotherapy. Ann Allergy Asthma Immunol. 2012 Dec;109(6):465-9. doi: 10.1016/j.anai.2012.10.003.

  PMID: 23176889 DERIVED

MeSH Terms

Conditions

Respiratory Sounds; Asthma; Hypersensitivity

Interventions

Injections, Subcutaneous; Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Gabriele de Vos, M.D.
• Organization: Jacobi Medical Center / Albert Einstein College of Medicine

gabriele.de-vos@einstein.yu.edu

7184152809

Study Officials

• Gabriele de Vos, M.D., M.Sc.

  Einstein, Jacobi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Allergy and Immunology)

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2008
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 28, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-04

Locations

US (1)