Trial record 1 of 1 for:    NCT01430403
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Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Inner City Asthma Consortium (ICAC)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01430403
First received: September 1, 2011
Last updated: September 11, 2013
Last verified: September 2013

September 1, 2011
September 11, 2013
September 2011
March 2014   (final data collection date for primary outcome measure)
Occurrence of one or more asthma exacerbations [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥ 10mg per day for ≥ 1 day.
Occurrence of a severe asthma exacerbation requiring systemic corticosteroid therapy or hospitalization during the fall season [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01430403 on ClinicalTrials.gov Archive Site
  • Virus-induced exacerbations as measured by an exacerbation that is associated with a virus detected using the nasal mucus samples. [ Time Frame: 4-5 month ] [ Designated as safety issue: Yes ]
  • Severity of asthma symptoms associated with a viral infection [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
    defined as the highest value among the following 3 variables: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep as a result of asthma; and number of days on which the participant had to slow down or discontinue play/physical activities over a two-week period
  • Number of exacerbations evaluated monthly with and without viral respiratory infections [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
  • Composite Asthma Severity Index [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Spirometry measurements [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Asthma control measurements [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
    Measurements based on scores obtained from Asthma Control Test (ACT) and Childhood Asthma Control Test (CACT)questionnaire
  • Economic outcomes [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • School absences [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Estimates of treatment adherence [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Safety data (adverse events and serious adverse events) [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Home allergen levels [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (ICAC-20)

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 approximately 4 -6 weeks prior to the start of the first day of each participant's school year.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Biological: Omalizumab
    Other Name: Xolair®
  • Drug: Fluticasone
    Other Name: Flovent® Diskus®
  • Biological: Placebo omalizumab
    The composition of the placebo omalizumab is the same as the active study drug without the omalizumab.
    Other Name: Placebo Xolair®
  • Biological: Placebo fluticasone
    Each placebo blister for fluticasone will contain 13mg fill of lactose powder.
    Other Name: Placebo Flovent® Diskus®
  • Experimental: Omalizumab
    Participants will receive active omalizumab (Xolair®) injections and a placebo inhaler. Each participant will receive omalizumab (Xolair®) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants will receive standardized specialist asthma care.
    Interventions:
    • Biological: Omalizumab
    • Biological: Placebo fluticasone
  • Experimental: Inhaled corticosteroid boost therapy (ICS)
    Participants in the Inhaled Corticosteroid (ICS) boost arm will receive active ICS and placebo injections of omalizumab (Xolair®). Self-administered fluticasone (Flovent ® Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone will used. All participants will receive standardized specialist asthma care.
    Interventions:
    • Drug: Fluticasone
    • Biological: Placebo omalizumab
  • Placebo Comparator: Placebo
    The placebo group will receive placebo injection and placebo inhaler. All participants will receive standardized specialist asthma care.
    Interventions:
    • Biological: Placebo omalizumab
    • Biological: Placebo fluticasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
494
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria

  • combined body weight (as measured at the screening visit) and total serum IgE (immunoglobulin E) level (as measured within 3 months of the screening visit) suitable for omalizumab (Xolair®) dosing.
  • a diagnosis of asthma by a clinician made more than 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician less than 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.
  • having a requirement for at least 100mcg fluticasone 100 mcg twice a day or equivalent at the Assumption of Care Visit and 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.

  • 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.
  • primary place of residence is in one of the pre-selected recruitment census tracts.
  • able to perform spirometry.
  • parent or legal guardian is willing to sign the written informed consent (age appropriate) prior to initiation of any study procedure.
  • willing to sign the assent form, if age appropriate.
  • a history of chickenpox or received the chickenpox vaccine.
  • insurance which covers costs of medications.
  • 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:

  • assigned to a treatment of less than 100mcg fluticasone twice a day or equivalent at the Assumption of Care Visit.
  • 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).
  • clinically significant laboratory abnormalities (not associated with the study indication) at the screening visit.
  • platelet counts less than 100 x 109/L at the screening visit.
  • 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.
  • live with a foster parent; not applicable if participant is able to provide consent.
  • do not have access to a phone (needed for scheduling appointments).
  • plan to move from the area during the study period.
  • have previously been treated with omalizumab (Xolair®) within 1 year of recruitment.
  • currently receiving or have received hyposensitization therapy to any allergen in the past year prior to recruitment.
  • received hyposensitization therapy to dust mite, Alternaria or cockroach for ≥ 6 months in the past 3 years prior to Recruitment.
  • a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure.
  • home schooled or in year round school.
  • Who are currently taking or who have taken any of the following medications within 4 weeks of the Screening Visit: Monoamine oxidase inhibitors (phenelzine, tranylcypromine); Tricyclic and tetracyclic antidepressants; beta adrenergic blocker drugs (both oral and topical); Anticonvulsants(carbamazepine, phenobarbital, phenytoin, mephobarbital, primidone, ethosuximide, methsuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, divalproex sodium, zonisamide); Protease inhibitors(ritonavir, indinavir, nelfinavir); Calcium channel blockers (verapamil, diltiazem); Modafinil; Tamoxifen; non-nucleoside reverse transcriptase inhibitors; Macrolide antibiotics*(erythromycin, clarithromycin, dirithromycin, troleandomycin); chloramphenicol; nefazodone; aprepitant; St Johns Wort; Rifampin*; Azole antifungals* (ketoconazole, fluconazole,itraconazole); Sibutramine*; bergamottin* (constituent of grapefruit juice).*may be rescreened if this therapy is short-lived
  • 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.

Participants who meet any of the following criteria are not eligible for assumption of care and may not be reassessed except where noted:

  • a current severe hypersensitivity to milk.
  • Who were enrolled in the previous ICAC trial, Inner-City Anti-IgE (immunoglobulin E) Therapy for Asthma (ICATA,ICAC-08/09).
  • 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, bronchiectasis, 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.
  • 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.
  • currently have diagnosed cancer, are currently being investigated for possible cancer, or who have a history of cancer.
  • do not primarily speak English (or Spanish at centers with Spanish speaking staff).
  • The participant's caretaker does not primarily speak English (or Spanish at centers with Spanish speaking staff); not applicable if participant is able to provide consent.
  • a history of severe(grade 3)anaphylactoid or anaphylactic reaction(s).
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01430403
DAIT ICAC-20
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Inner City Asthma Consortium (ICAC)
Study Chair: Stanley Szefler, MD National Jewish Health
Study Chair: Stephen Teach, MD, MPH Children's Research Institute
National Institute of Allergy and Infectious Diseases (NIAID)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP