Clinical trial NCT01362621: Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma
Official title: A 2-year Prospective, Multi-center, Observational and Epidemiologic Outcomes Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Allergic Asthma
Keywords: Allergic asthma
Pediatrics
Exacerbations
Perennial aeroallergens
Inhaled corticosteroids
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2011-05-30
Enrollment: 474
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 6 to less than 12 years old with moderate to severe allergic asthma for at least 12 months, treated with inhaled corticosteroids for at least 3 months but remaining symptomatic

Brief summary: The study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to \< 12 years of age, managed in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Total IgE ≥30 IU (historical values obtained within 3 months of screening visit will be accepted). If historic result not available, to be obtained at screening visit.
* Diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
* Documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific IgE test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
* Prescribed inhaled corticosteroid for at least 3 months prior to screening (A) and having evidence of inadequately controlled disease either with at least one from list (B) OR history of asthma-related exacerbations as defined in (C). \[e.g., A and (B or C)\]

A. Fluticasone DPI \> 200 mcg/day or equivalent ex-valve dose ICS, or if ≤ 200 mcg fluticasone DPI or equivalent plus another daily controller medication (i.e. LABA, leukotriene antagonist or theophylline)

B. At least one of the following in the preceding 4 weeks prior to the screening visit:

* on average asthma symptoms \> 2 days/week or multiple times in a day on ≤ 2 days/week
* nighttime awakenings ≥ 2 times/month due to asthma symptoms
* use of SABAs \> 2 times/week on average
* some limitation in activity due to asthma
* on spirometric evaluation, FEV1 ≤ 80% of predicted, FEV1/FVC ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best

C. Minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit

Exclusion Criteria:

* Subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of Visit 1 or a biologic agent within 120 days of Visit 1
* Subjects with a history of prior use of omalizumab
* Subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
* Subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
* Subjects with elevated serum IgE levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich Syndrome

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The change from basline in Childhood Asthma Control Test
timeFrame: 2 years
measure: The change from baseline in total Wasserfallen Clinical Symptom Score
timeFrame: 2 years
Secondary outcomes:
measure: The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S))
timeFrame: 2 years
measure: The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
timeFrame: 2 years
measure: The number of days of missed school.
timeFrame: 2 years
measure: The number of days of missed work.
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Crescent City
country: United States
facility: Novartis Investigative Site
state: California
city: Fresno
country: United States
facility: Novartis Investigative Site
state: California
city: Oakland
country: United States
facility: Novartis Investigative Site
state: California
city: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Roseville
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Thornton
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Albany
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Savannah
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Evansville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Cynthiana
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Metarie
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Burlington
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Stevensville
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Plymouth
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Berkeley Heights
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Brick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Summit
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: West Orange
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Batavia
country: United States
facility: Novartis Investigative Site
state: New York
city: Brooklyn
country: United States
facility: Novartis Investigative Site
state: New York
city: Rockville Center
country: United States
facility: Novartis Investigative Site
state: New York
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Toledo
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Gresham
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Allentown
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Altoona
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Providence
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Kingsport
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Murray
country: United States
facility: Novartis Investigative Site
state: Utah
city: South Burlington
country: United States
facility: Novartis Investigative Site
state: Vermont
city: Emporia
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Norfolk
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Bellingham
country: United States
facility: Novartis Investigative Site
state: Washington
city: Madison
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
References: