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A Study to Evaluate the Efficacy of Xolair in Atopic Asthmatics (EXACT)
This study is currently recruiting participants.
Verified by Genentech, August 2009
First Received: November 17, 2004   Last Updated: August 31, 2009   History of Changes
Sponsor: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00096954
  Purpose

This is a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that will enroll approximately 300 subjects. These subjects will be 12-75 years old with atopic asthma, have a history of asthma exacerbations, have elevated serum total IgE, have a baseline FEV1 ≥ 80% predicted, and be on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor antagonist [LTRA], or immunotherapy).


Condition Intervention Phase
Asthma
Drug: omalizumab
Drug: placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: A Prospective, Randomized, Double-Blind Study of the Efficacy of Xolair in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Average rate of asthma exacerbations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects experiencing one or more protocol-defined asthma exacerbations during the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in nocturnal and daytime asthma symptom scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in pulmonary function as measured by FEV1 percent predicted [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2005
Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: omalizumab
subcutaneous injection
2: Placebo Comparator Drug: placebo
subcutaneous injection

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a documented history of asthma as well as evidence of ≥ 12% reversibility of FEV1. Evidence of ≥ 12% reversibility of FEV1 may be obtained by any one of the following measures: 1) Documentation of ≥ 12% reversibility of FEV1 after albuterol administration at any time during the preceding 24 months; 2) Documentation of ≥ 12% improvement in FEV1 with two separate measurements obtained within a 4-week period surrounding an asthma exacerbation during the preceding 24 months; 3) Demonstration of ≥ 12%reversibility of FEV1 after albuterol administration at the time of screening
  • Have screening FEV1 ≥ 80% predicted normal value
  • Have a positive skin test (diameter of wheal ≥ 3 mm vs. control) or in vitro RAST(R) or ImmunoCap(R) to one relevant perennial aeroallergen such as cat or house dust mites documented within the previous year
  • Be receiving at least an inhaled corticosteroid dosage of fluticasone dry powder inhaler (DPI) ≥ 200 ug/day or equivalent ex-valve dose during the 12 weeks prior to the screening visit
  • Have had at least one asthma exacerbation requiring treatment with at least one course of oral or intravenous corticosteroids or a doubling of the dose of inhaled corticosteroids for at least 3 days in the 12 months prior to screening despite being on a minimum of fluticasone DPI ≥ 200 ug/day or equivalent ex-valve dose
  • During the 4-week run-in period prior to randomization, demonstrate evidence of inadequate asthma symptom control despite inhaled corticosteroids with or without other controller asthma medications (e.g., LABA, LTRA, immunotherapy). Inadequate asthma symptom control is defined as at least one of the following reported on the subject diary card during the 4-week run-in period: Daytime asthma symptoms as a score of ≥ 1 (scale of 0-4) on at least 20 of 28 days (missing data to be treated as a day with no symptoms) and a mean symptom score of ≥ 1.5 (mean will be calculated based on only data supplied; missing values will not be considered) or Nighttime awakening because of asthma symptoms (more than 4 times during the 4-week run-in period)
  • Meet the study drug-dosing table eligibility criteria (serum baseline IgE level ≥ 30 to ≤ 1300 IU/mL and body weight ≥ 20 to ≤ 150 kg)
  • If a female of childbearing potential, use an effective method of contraception (in the opinion of the investigator) to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study

Exclusion Criteria:

  • Have received chronic systemic corticosteroids (oral or intravenous) within 3 months or have received a burst of oral corticosteroids within the last 2 weeks prior to screening
  • Have received Xolair therapy at any time within 12 months prior to screening
  • Are pregnant or lactating
  • Have a known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
  • Have a lifetime history of smoking > 10-pack years
  • Have active lung disease other than asthma (e.g., chronic bronchitis, emphysema, cystic fibrosis, chronic obstructive pulmonary disease)
  • Have a history of upper respiratory infection or lower respiratory infection within the 30 days prior to randomization
  • Have a diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma
  • Have taken immunosuppressants or other investigational drugs within the 30 days prior to screening
  • Have a significant medical illness other than asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096954

Contacts
Contact: Trial Information Support Line 888-662-6728

  Show 56 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Dana McClintock, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: Q2982g
Study First Received: November 17, 2004
Last Updated: August 31, 2009
ClinicalTrials.gov Identifier: NCT00096954     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Xolair
Atopic Asthma

Additional relevant MeSH terms:
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab

ClinicalTrials.gov processed this record on February 08, 2010