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

NCT01362621 | Completed

• 1 other identifier: CIGE025BUS26
• Study Type: observational
• Target: 474
• Locations: 2 countries
• Sites: 51

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.

Conditions

Moderate to Severe Allergic Asthma

Keywords

Allergic asthma; Pediatrics; Exacerbations; Perennial aeroallergens; Inhaled corticosteroids

Outcome Measures

Primary Outcomes (2)

• The change from basline in Childhood Asthma Control Test

  2 years

• The change from baseline in total Wasserfallen Clinical Symptom Score

  2 years

Secondary Outcomes (4)

• 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

Study Arms (1)

Children 6 to less than 12 years of age

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Genentech, Inc.: collaborator

Study Sites (51)

Novartis Investigative Site

Birmingham, Alabama, 35209, United States

Location

Novartis Investigative Site

Crescent City, California, 95531, United States

Location

Novartis Investigative Site

Fresno, California, 93726, United States

Location

Novartis Investigative Site

Oakland, California, 94609, United States

Location

Novartis Investigative Site

Orange, California, 92868, United States

Location

Novartis Investigative Site

Roseville, California, 95678, United States

Location

Novartis Investigative Site

Sacramento, California, 95819, United States

Location

Novartis Investigative Site

San Diego, California, 92120, United States

Location

Novartis Investigative Site

Walnut Creek, California, 94598, United States

Location

Novartis Investigative Site

Thornton, Colorado, 80233, United States

Location

Novartis Investigative Site

Albany, Georgia, 31707, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30342, United States

Location

Novartis Investigative Site

Columbus, Georgia, 31904, United States

Location

Novartis Investigative Site

Savannah, Georgia, 31406, United States

Location

Novartis Investigative Site

Evansville, Indiana, 47713, United States

Location

Novartis Investigative Site

Topeka, Kansas, 66606, United States

Location

Novartis Investigative Site

Cynthiana, Kentucky, 41031, United States

Location

Novartis Investigative Site

Metarie, Louisiana, 70002, United States

Location

Novartis Investigative Site

Burlington, Massachusetts, 01801, United States

Location

Novartis Investigative Site

Kalamazoo, Michigan, 49008, United States

Location

Novartis Investigative Site

Stevensville, Michigan, 49127, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, 55402, United States

Location

Novartis Investigative Site

Plymouth, Minnesota, 55441, United States

Location

Novartis Investigative Site

Jackson, Mississippi, 39202, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63104, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 16945, United States

Location

Novartis Investigative Site

Berkeley Heights, New Jersey, 07922, United States

Location

Novartis Investigative Site

Brick, New Jersey, 08724, United States

Location

Novartis Investigative Site

Summit, New Jersey, 07901, United States

Location

Novartis Investigative Site

West Orange, New Jersey, 07052, United States

Location

Novartis Investigative Site

Batavia, New York, 14020, United States

Location

Novartis Investigative Site

Brooklyn, New York, 11229, United States

Location

Novartis Investigative Site

Rockville Centre, New York, 11570, United States

Location

Novartis Investigative Site

High Point, North Carolina, 27262, United States

Location

Novartis Investigative Site

Toledo, Ohio, 43604, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73112, United States

Location

Novartis Investigative Site

Gresham, Oregon, 97030, United States

Location

Novartis Investigative Site

Allentown, Pennsylvania, 18104, United States

Location

Novartis Investigative Site

Altoona, Pennsylvania, 16601, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15212, United States

Location

Novartis Investigative Site

Providence, Rhode Island, 02906, United States

Location

Novartis Investigative Site

Kingsport, Tennessee, 37660, United States

Location

Novartis Investigative Site

Dallas, Texas, 75230, United States

Location

Novartis Investigative Site

Houston, Texas, 77054, United States

Location

Novartis Investigative Site

Murray, Utah, 84107, United States

Location

Novartis Investigative Site

South Burlington, Vermont, 05403, United States

Location

Novartis Investigative Site

Emporia, Virginia, 23847, United States

Location

Novartis Investigative Site

Norfolk, Virginia, 23507, United States

Location

Novartis Investigative Site

Bellingham, Washington, 98225, United States

Location

Novartis Investigative Site

Madison, Wisconsin, 53715, United States

Location

Novartis Investigative Site

San Juan, 00917, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITH DNA

A venous blood sample was collected at either screening (Visit 1) or enrollment (Visit 2). These samples were collected for DNA extraction. The extracted DNA is stored at Novartis Pharmaceuticals Corporation for pharmacogenetic analysis and storage.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: May 30, 2011
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

US (50); PR (1)