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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01362621
First received: May 26, 2011
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

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.


Condition
Moderate to Severe Allergic Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The change from basline in Childhood Asthma Control Test [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The change from baseline in total Wasserfallen Clinical Symptom Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The number of days of missed school. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The number of days of missed work. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.


Enrollment: 474
Study Start Date: February 2008
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children 6 to less than 12 years of age

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362621

  Show 51 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Genentech, Inc.
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01362621     History of Changes
Other Study ID Numbers: CIGE025BUS26
Study First Received: May 26, 2011
Last Updated: June 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
Allergic asthma
Pediatrics
Exacerbations
Perennial aeroallergens
Inhaled corticosteroids

Additional relevant MeSH terms:
Asthma
Disease Progression
Bronchial Diseases
Disease Attributes
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014