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Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma

9 april 2012 bijgewerkt door: Novartis Pharmaceuticals

A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma

A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study was designed to provide one year efficacy and safety data for subcutaneous (SC) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to National Heart, Lung and Blood Institute (NHLBI) step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

628

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35209
        • Alabama Allergy and Asthma Center
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72202
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Verenigde Staten, 72205
        • Clinical Research Center
    • California
      • Huntington Beach, California, Verenigde Staten, 92647
        • Allergy and Asthma Specialists Medical Group
      • Huntington Beach, California, Verenigde Staten, 92647
        • Pediatric Care and Medical Group
      • Long Beach, California, Verenigde Staten, 90806
        • West Coast Clinical Trials
      • Mission Viejo, California, Verenigde Staten, 92691
        • Southern California Research Center
      • Orange, California, Verenigde Staten, 92868
        • Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology
      • Palmdale, California, Verenigde Staten, 93551
        • CA Allergy & Asthma Med Group
      • Palo Alto, California, Verenigde Staten, 94304
        • Dr. Joann Blessing-Moore
      • Riverside, California, Verenigde Staten, 92506
        • Integrated Research Group
      • San Diego, California, Verenigde Staten, 92120
        • Allergy Associates Medical Group
      • San Diego, California, Verenigde Staten, 92123
        • Allergy and Asthma Medical Group & Research Center
      • San Jose, California, Verenigde Staten, 95117
        • Allergy and Asthma Associates of Santa Clara Valley RC
      • Santa Monica, California, Verenigde Staten, 90404
        • 1304 15th St
      • Stockton, California, Verenigde Staten, 95207
        • Bensch Research Associates
      • Walnut Creek, California, Verenigde Staten, 94598
        • Allergy & Asthma Med Group of Diablo Valley CR
    • Colorado
      • Denver, Colorado, Verenigde Staten, 80206
        • National Jewish Medical and Research Center
    • Florida
      • Miami, Florida, Verenigde Staten, 33155
        • Miami Children's Hospital
    • Georgia
      • Albany, Georgia, Verenigde Staten, 31707
        • Georgia Pollens
      • Atlanta, Georgia, Verenigde Staten, 30342
        • Family Allergy and Asthma Center, PC
      • Savannah, Georgia, Verenigde Staten, 31406
        • Aeroallergy Research Labs of Savannah, Inc
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • Rush University Medical Center
    • Maryland
      • Elliott City, Maryland, Verenigde Staten, 21042
        • Asthma & Allergy Center
    • Massachusetts
      • North Dartmouth, Massachusetts, Verenigde Staten, 02747
        • Northeast Med Research Associates
    • Missouri
      • St. Louis, Missouri, Verenigde Staten, 63104
        • St. Louis University School of Medicine
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68114
        • Midwest Allergy & Asthma Clinic
    • New Jersey
      • Brick, New Jersey, Verenigde Staten, 08724
        • Ocean Allergy & Respiratory Research Center
      • Newark, New Jersey, Verenigde Staten, 07101
        • UMDNJ
    • New York
      • Buffalo, New York, Verenigde Staten, 14222
        • Womes And childrens Hospital of Buffalo
      • Ithaca, New York, Verenigde Staten, 14850
        • Asthma & Allergy Associates
      • Liverpool, New York, Verenigde Staten, 13088
        • Allergy and Asthma Diagnostic Office
      • Rockville Center, New York, Verenigde Staten, 11570
        • Island Medical Research (Allergy and Asthma Center)
    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27710
        • Duke University Medical Center
      • High Point, North Carolina, Verenigde Staten, 27262
        • Allergy & Asthma Center of North carolina
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45231
        • Bernstein Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73112
        • Resp Dis of Children and Adolescents
    • Oregon
      • Medford, Oregon, Verenigde Staten, 97504
        • Clinical Research Institute of Southern Oregon
    • Pennsylvania
      • Altoona, Pennsylvania, Verenigde Staten, 16601
        • 501 Howard Av
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15212
        • West Penn Allegheny General Health System
      • Upland, Pennsylvania, Verenigde Staten, 19013
        • Asthma and Allergy Associates
    • Rhode Island
      • Lincoln, Rhode Island, Verenigde Staten, 02865
        • AAPRI Clinical Research Institute
    • Tennessee
      • Knoxville, Tennessee, Verenigde Staten, 37922
        • Allergy Assoc., The ASthma, Allergy & Sinus Ctr
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Vanderbilt University
    • Texas
      • Dallas, Texas, Verenigde Staten, 75230
        • Pediatric Allergy/Immunology Associates, PA
      • Dallas, Texas, Verenigde Staten, 75230
        • Pediatric Pulmonary Association of North Texas
      • Ft. Worth, Texas, Verenigde Staten, 76132
        • North Texas Institute for Clinical Trials
      • Houston, Texas, Verenigde Staten, 77030
        • Baylor College of Medicine
      • Houston, Texas, Verenigde Staten, 77054
        • 7707 Fannin/Ste. 195
      • San Antonio, Texas, Verenigde Staten, 78229
        • Sylvanna Research
    • Utah
      • South Jordan, Utah, Verenigde Staten, 84095
        • CopperView Medical Center
    • Virginia
      • Norfolk, Virginia, Verenigde Staten, 23507
        • Childrens Hospital of The Kings Daughters
      • Richmond, Virginia, Verenigde Staten, 23219
        • Virgina Commonwealth
    • Washington
      • Seattle, Washington, Verenigde Staten, 98105
        • A.S.T.H.M.A., Inc.
      • Spokane, Washington, Verenigde Staten, 99204
        • 508 W 6th Av
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Medical College of Wisconsin

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar tot 11 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion criteria:

  • Parent or legal guardian was informed of the study procedures and medications and gave written informed consent.
  • Outpatient males and females aged 6 - < 12 years on study entry, with body weight between 20 and 150 kg.
  • Total serum IgE level ≥ 30 to ≤ 1300 IU.
  • Diagnosis of allergic asthma ≥ 1 year duration, according to American Thoracic Society (ATS) criteria, and a screening history consistent with clinical features of moderate or severe persistent asthma according to National Heart Lung and Blood Institute (NHLBI) guidelines.
  • Positive prick skin test to at least one perennial allergen, documented within the past 2 years or taken at Screening. A radioallergosorbent test (RAST) could have been performed for patients with a borderline skin prick test result after consultation with Novartis clinical personnel.
  • Patients with ≥ 12% increase in forced expiratory volume in 1 second (FEV1) over starting value within 30 minutes of taking up to 4 puffs (4x100 µg) salbutamol (albuterol) or nebulized salbutamol up to 5 mg (or equivalent of alternative B2-agonist) documented within the past year, at screening, during the run-in period, or prior to randomization. Patients were not to take their long acting B2-agonist (LABA) medication within 12 hours of reversibility testing.
  • Clinical features of moderate or severe persistent asthma (at least step 3) despite therapy at step 3 or 4 (at least medium dose inhaled corticosteroid (ICS) - fluticasone dry-powder inhaler (DPI) ≥ 200 mg/day or equivalent with or without other controller medications).
  • Documented history of experiencing asthma exacerbations and demonstrated inadequate symptom control during the last 4 weeks of run-in despite receiving an equivalent dose of fluticasone DPI ≥ 200 mg/day total daily ex-valve dose.

Exclusion criteria:

  • Patients who received systemic corticosteroids for reasons other than asthma, beta-adrenergic antagonists by any route, anticholinergics within 24 hours of Screening, methotrexate, gold salts, cyclosporin or troleandomycin, or had received desensitization therapy with less than 3 months of stable maintenance doses prior to Screening.
  • Patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction, a history of allergy to antibiotics, with aspirin or other non-steroidal anti-inflammatory drugs (NSAID)-related asthma (unless the NSAID could be avoided), with active lung disease or acute sinusitis/chest infection, elevated serum IgE levels for other reasons, presence/history of a clinically significant uncontrolled systemic disease, cancer, abnormal, electrocardiogram (ECG) in the previous month, or platelets ≤ 100 x 109/L or clinically significant laboratory abnormalities at Screening.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Omalizumab
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
Geneesmiddel: Omalizumab
The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose.
Geneesmiddel: Fluticasone
Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.
Placebo-vergelijker: Placebo
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
Geneesmiddel: Fluticasone
Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.
Geneesmiddel: Placebo
Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period
Tijdsspanne: Baseline to end of the fixed-dose steroid treatment period (Week 24)
A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period.
Baseline to end of the fixed-dose steroid treatment period (Week 24)
Percentage of Participants With at Least 1 Adverse Event
Tijdsspanne: Baseline to end of the study (Week 68)
See Adverse Events module for details.
Baseline to end of the study (Week 68)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period
Tijdsspanne: Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period
Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question "How did you sleep last night?", with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement.
Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period
Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period
Tijdsspanne: Baseline to end of the treatment period (Week 52)
A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period.
Baseline to end of the treatment period (Week 52)
Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period
Tijdsspanne: Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period
Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication.
Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period
Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)
Tijdsspanne: Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24)
PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates.
Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2004

Primaire voltooiing (Werkelijk)

1 maart 2008

Studie voltooiing (Werkelijk)

1 maart 2008

Studieregistratiedata

Eerst ingediend

18 maart 2004

Eerst ingediend dat voldeed aan de QC-criteria

19 maart 2004

Eerst geplaatst (Schatting)

22 maart 2004

Updates van studierecords

Laatste update geplaatst (Schatting)

11 april 2012

Laatste update ingediend die voldeed aan QC-criteria

9 april 2012

Laatst geverifieerd

1 april 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CIGE025AIA05

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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