| Purpose: |
|
While the increase in the prevalence of asthma has abated, levels of asthma morbidity and
mortality remain near record highs. An asthma exacerbation is a major factor contributing
to morbidity, and even mortality in patients with asthma. Although current approaches to
treatment have reduced these risks, asthma exacerbations are major problems for inner-city
patients and their families, and prevention of these events continues to be a significant
challenge. In children with asthma, there are predictable seasonal epidemics of
exacerbations, especially during the fall season, otherwise known as the "September
epidemic." The purpose of this trial is to compare the efficacy of 4 to 5 months of three
treatments ― omalizumab, corticosteroid therapy boost, and placebo ― in reducing fall
exacerbations in inner-city children and adolescents with allergic persistent asthma when
initiated one month prior to the start of the fall viral season.
|
| Criteria: |
|
Inclusion Criteria
1. Males and females ages 6 - 17 years, inclusive, at consent.
2. With combined body weight (as measured at pre-screening or screening visit) and total
serum IgE level (as measured within 3 months of the screening visit) suitable for
omalizumab dosing.
3. Who have had a diagnosis of asthma by a clinician made > 1 year ago, as reported at
recruitment, or a confirmed asthma diagnosis based on characterization for
participants enrolled in the ICAC study Registry for Asthma Characterization and
Recruitment (RACR).
4. Who meet at least one of the following criteria:
i. One or more asthma-related exacerbations, separated by at least two weeks,
requiring treatment with a systemic corticosteroid course in the previous 12 months.
ii. One or more asthma-related overnight hospitalizations in the past 12 months.
5. With a positive prick skin-test to at least one perennial allergen (i.e. dust mite,
cockroach, mold, cat, dog, rat, mouse) documented at the screening visit or at a ICAC
study visit within 12 months of the screening visit.
6. Whose primary place of residence is in one of the pre-selected recruitment census
tracts.
7. Who are able to perform spirometry.
8. Whose parent or legal guardian is willing to sign the written informed consent (age
appropriate) prior to initiation of any study procedure.
9. Who are willing to sign the assent form, if age appropriate.
10. Who have a history of chickenpox or received the chickenpox vaccine.
11. Who have insurance which covers costs of medications.
12. Who have not used and do not plan to restart the following medications in the 7 days
prior to the first visit: tricyclic antidepressants, ketaconazole, or beta adrenergic
blocker drugs (both oral and topical).
Exclusion Criteria:
Participants who meet any of the following criteria are not eligible for enrollment but
may be reassessed. Participants:
1. Who have inadequate adherence (<30%) during the run-in period as defined by the
average of the assessments at the Randomization visit and the visit directly
preceding it, as determined by the relevant device counter .
2. Who, at screening or randomization visits, are assigned a treatment step level < 2.
3. Who are pregnant or lactating. Females of child-bearing potential (post-menarche)
must be abstinent or use a medically acceptable birth control method throughout the
study (e.g. oral, subcutaneous, mechanical, or surgical contraception).
4. Who during the run-in (from consent to randomization) have > 4 bursts of systemic
corticosteroids or who are on systemic corticosteroids for 14 out of 21 days during a
single course. A burst is defined as a minimum dose of 20 mg or more of prednisone,
prednisolone, or methylprednisone, taken per day for 3 of any 5 consecutive days; or
dexamethasone as a minimum dose of 10 mg per day for one or more days.
5. With clinically significant laboratory abnormalities (not associated with the study
indication) at the screening visit.
6. With platelet counts < 100 x 109/L at the screening visit.
7. Who are currently participating in another asthma-related pharmaceutical study or
intervention study or who have participated in another asthma-related pharmaceutical
study or intervention study in the month prior to Recruitment.
8. Who live with a foster parent; not applicable if participant is able to provide
consent.
9. Who do not have access to a phone (needed for scheduling appointments).
10. Who plan to move from the area during the study period.
11. Who have previously been treated with anti-IgE therapy within 1 year of recruitment.
12. Who are currently receiving or have received hyposensitization therapy to any
allergen in the past year prior to recruitment.
13. Who have received hyposensitization therapy to dust mite, Alternaria or cockroach for
≥ 6 months in the past 3 years prior to Recruitment.
14. Who have had a life-threatening asthma exacerbation in the last 2 years requiring
intubation, mechanical ventilation, or resulting in a hypoxic seizure.
15. Who are home schooled or in year round school.
16. Who will not allow the study clinician, an asthma specialist, to manage their disease
for the duration of the study or who are not willing to change their asthma
medications to follow the protocol.
17. Who have any medical illnesses that in the opinion of the investigators would a.)
increase the risk the subject would incur by participating in the study; b.)
interfere with the measured outcomes of the study; or c.) interfere with the
performance of the study procedures. Examples of such diseases are: cystic fibrosis,
bronchiestasis, type 1 diabetes, hemophilia, Von Willebrands disease, sickle cell
disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin
E syndrome, parasite infections, Wiskott-Aldrich Syndrome or allergic
bronchopulmonary aspergillosis.
18. Who have known hypersensitivity to any ingredients, including excipients (sucrose,
histidine, polysorbate 20) of the study medication or drugs related to omalizumab
(e.g. monoclonal antibodies, polyclonal gamma globulin) or fluticasone.
19. Who currently have diagnosed cancer, are currently being investigated for possible
cancer, or who have a history of cancer.
20. Who do not primarily speak English (or Spanish at centers with Spanish speaking
staff).
21. Whose caretaker does not primarily speak English (or Spanish at centers with Spanish
speaking staff); not applicable if participant is able to provide consent.
22. Who have a history of anaphylaxis.
|