Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma

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

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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Allergic Asthma

• Study Type: Observational
• Enrollment (Actual): 474

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Novartis Investigative Site
  • California
    • Crescent City, California, United States, 95531
      • Novartis Investigative Site
    • Fresno, California, United States, 93726
      • Novartis Investigative Site
    • Oakland, California, United States, 94609
      • Novartis Investigative Site
    • Orange, California, United States, 92868
      • Novartis Investigative Site
    • Roseville, California, United States, 95678
      • Novartis Investigative Site
    • Sacramento, California, United States, 95819
      • Novartis Investigative Site
    • San Diego, California, United States, 92120
      • Novartis Investigative Site
    • Walnut Creek, California, United States, 94598
      • Novartis Investigative Site
  • Colorado
    • Thornton, Colorado, United States, 80233
      • Novartis Investigative Site
  • Georgia
    • Albany, Georgia, United States, 31707
      • Novartis Investigative Site
    • Atlanta, Georgia, United States, 30342
      • Novartis Investigative Site
    • Columbus, Georgia, United States, 31904
      • Novartis Investigative Site
    • Savannah, Georgia, United States, 31406
      • Novartis Investigative Site
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Novartis Investigative Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Novartis Investigative Site
  • Kentucky
    • Cynthiana, Kentucky, United States, 41031
      • Novartis Investigative Site
  • Louisiana
    • Metarie, Louisiana, United States, 70002
      • Novartis Investigative Site
  • Massachusetts
    • Burlington, Massachusetts, United States, 01801
      • Novartis Investigative Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49008
      • Novartis Investigative Site
    • Stevensville, Michigan, United States, 49127
      • Novartis Investigative Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Novartis Investigative Site
    • Plymouth, Minnesota, United States, 55441
      • Novartis Investigative Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Novartis Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 16945
      • Novartis Investigative Site
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Novartis Investigative Site
    • Brick, New Jersey, United States, 08724
      • Novartis Investigative Site
    • Summit, New Jersey, United States, 07901
      • Novartis Investigative Site
    • West Orange, New Jersey, United States, 07052
      • Novartis Investigative Site
  • New York
    • Batavia, New York, United States, 14020
      • Novartis Investigative Site
    • Brooklyn, New York, United States, 11229
      • Novartis Investigative Site
    • Rockville Center, New York, United States, 11570
      • Novartis Investigative Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Novartis Investigative Site
  • Ohio
    • Toledo, Ohio, United States, 43604
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Novartis Investigative Site
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Novartis Investigative Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Novartis Investigative Site
    • Altoona, Pennsylvania, United States, 16601
      • Novartis Investigative Site
    • Pittsburgh, Pennsylvania, United States, 15212
      • Novartis Investigative Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Novartis Investigative Site
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Novartis Investigative Site
    • Houston, Texas, United States, 77054
      • Novartis Investigative Site
  • Utah
    • Murray, Utah, United States, 84107
      • Novartis Investigative Site
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • Novartis Investigative Site
  • Virginia
    • Emporia, Virginia, United States, 23847
      • Novartis Investigative Site
    • Norfolk, Virginia, United States, 23507
      • Novartis Investigative Site
  • Washington
    • Bellingham, Washington, United States, 98225
      • Novartis Investigative Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children 6 to less than 12 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change from basline in Childhood Asthma Control Test	2 years
The change from baseline in total Wasserfallen Clinical Symptom Score	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S))	2 years
The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)	2 years
The number of days of missed school.	2 years
The number of days of missed work.	2 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Collaborators: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: May 27, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Estimate): June 16, 2011
• Last Update Submitted That Met QC Criteria: June 15, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Pediatrics; Exacerbations; Inhaled corticosteroids; Allergic asthma; Perennial aeroallergens
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Disease Progression; Asthma
• Other Study ID Numbers: CIGE025BUS26