Clinical trial NCT00870584: Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
Official title: A 26-week Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Persistent Allergic Asthma
Keywords: Asthma; asthma management; asthma impairment ; Xolair ; omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2009-03-27
Enrollment: 271
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines


Eligibility criteria: Inclusion Criteria:

* Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average:

  * Symptoms \> 2 days/week
  * Night-time awakenings ≥1 time/week
  * Short-acting beta2-agonist (SABA) use for symptom control \>2 days/week forced expiratory volume in 1 second (FEV1) ≤ 80% predicted

Exclusion Criteria:

* History of intubation for asthma.
* An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
* Less than 3 months of stable maintenance oral corticosteroid therapy for asthma

Other protocol-defined inclusion/exclusion criteria applied

Primary outcomes:
measure: Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Jasper Summit Research, LLC
state: Alabama
city: Anchorage
country: United States
facility: Allergy Asthma and Immunology Center of Alaska
state: Alaska
city: Scottsdale
country: United States
facility: Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD
state: Arizona
city: Encinitas
country: United States
facility: Waren W. Pleskow, MD
state: California
city: Fresno
country: United States
facility: William Ebbeling, MD, Inc
state: California
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group, Inc
state: California
city: Palmdale
country: United States
facility: California Allergy & Asthma Medical Group
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group, Inc
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research, Inc.
state: California
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc
state: Florida
city: Hialeah
country: United States
facility: Palm Spring Research Institute, Inc
state: Florida
city: Pensacola
country: United States
facility: Integrity Research, LLC
state: Florida
city: Sarasota
country: United States
facility: Hugh Windom, MD, PA
state: Florida
city: South Miami
country: United States
facility: South Miami Clinical Research, LLC
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze and Itch Associates, LLC
state: Illinois
city: Skokie
country: United States
facility: Chest Medicine Clinical Services
state: Illinois
city: Indianapolis
country: United States
facility: Clinical Research Center of Indiana
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Allergy & Asthma Center
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Crescent Springs
country: United States
facility: Abraham Research, PLLC
state: Kentucky
city: Metairie
country: United States
facility: Rx R&D
state: Louisiana
city: Opelousas
country: United States
facility: Acadiana Medicine Clinic
state: Louisiana
city: Bangor
country: United States
facility: Paul A Shapero, MD
state: Maine
city: Baltimore
country: United States
facility: Chesapeake Clinical Research
state: Maryland
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Saint Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: Bronx
country: United States
facility: Alan Kaufman, MD
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center, Division of Pediatric Pulmonology
state: New York
city: Rochester
country: United States
facility: Allergy Asthma Immunology of Rochester Research Center
state: New York
city: High Point
country: United States
facility: Allergy & Asthma Center of NC, PA
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Medical Research
state: North Carolina
city: Canton
country: United States
facility: Allergy and Respiratory Center
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Allergy & Asthma Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Lake Oswego
country: United States
facility: Baker Allergy Asthma and Dermatology Research Center, LLC
state: Oregon
city: Philadelphia
country: United States
facility: Asthma Allergy & Pulmonary Associates
state: Pennsylvania
city: Lincoln
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Dallas
country: United States
facility: Pediatric Pulmonary Associates of North Texas, PA
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Fort Worth
country: United States
facility: North Texas Institute for Clinical Trials
state: Texas
city: Houston
country: United States
facility: Allergy & Asthma Associates
state: Texas
city: Lynchburg
country: United States
facility: Lynchburg Pulmonary Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Adult and Pediatric Allergy and Asthma PC
state: Virginia
city: Seattle
country: United States
facility: Asthma Inc.
state: Washington
city: Spokane
country: United States
facility: Pulmonary and Research Associates
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: