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

Moderate to Severe Allergic Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362621
• Other study ID #: CIGE025BUS26
• Status: Completed
• Phase: N/A
• First received: May 26, 2011
• Last updated: June 15, 2011
• Start date: February 2008

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Disease Progression
• Moderate to Severe Allergic Asthma

Locations

Country	Name	City	State
Puerto Rico	Novartis Investigative Site	San Juan
United States	Novartis Investigative Site	Albany	Georgia
United States	Novartis Investigative Site	Allentown	Pennsylvania
United States	Novartis Investigative Site	Altoona	Pennsylvania
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Batavia	New York
United States	Novartis Investigative Site	Bellingham	Washington
United States	Novartis Investigative Site	Berkeley Heights	New Jersey
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Brick	New Jersey
United States	Novartis Investigative Site	Brooklyn	New York
United States	Novartis Investigative Site	Burlington	Massachusetts
United States	Novartis Investigative Site	Columbus	Georgia
United States	Novartis Investigative Site	Crescent City	California
United States	Novartis Investigative Site	Cynthiana	Kentucky
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Emporia	Virginia
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Gresham	Oregon
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Kalamazoo	Michigan
United States	Novartis Investigative Site	Kingsport	Tennessee
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Metarie	Louisiana
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Murray	Utah
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Oakland	California
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Plymouth	Minnesota
United States	Novartis Investigative Site	Providence	Rhode Island
United States	Novartis Investigative Site	Rockville Center	New York
United States	Novartis Investigative Site	Roseville	California
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Savannah	Georgia
United States	Novartis Investigative Site	South Burlington	Vermont
United States	Novartis Investigative Site	Stevensville	Michigan
United States	Novartis Investigative Site	Summit	New Jersey
United States	Novartis Investigative Site	Thornton	Colorado
United States	Novartis Investigative Site	Toledo	Ohio
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigative Site	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from basline in Childhood Asthma Control Test		2 years	No
Primary	The change from baseline in total Wasserfallen Clinical Symptom Score		2 years	No
Secondary	The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S))		2 years	No
Secondary	The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)		2 years	No
Secondary	The number of days of missed school.		2 years	No
Secondary	The number of days of missed work.		2 years	No