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

9. April 2012 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

628

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Jahre bis 11 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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.
Arzneimittel: 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-Komparator: 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.
Arzneimittel: 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.
Arzneimittel: Placebo
Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period
Zeitfenster: 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
Zeitfenster: Baseline to end of the study (Week 68)
See Adverse Events module for details.
Baseline to end of the study (Week 68)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Novartis Pharmaceuticals

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2004

Primärer Abschluss (Tatsächlich)

1. März 2008

Studienabschluss (Tatsächlich)

1. März 2008

Studienanmeldedaten

Zuerst eingereicht

18. März 2004

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. März 2004

Zuerst gepostet (Schätzen)

22. März 2004

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

11. April 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. April 2012

Zuletzt verifiziert

1. April 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CIGE025AIA05

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