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

9. dubna 2012 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Intervenční

Zápis (Aktuální)

628

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

6 let až 11 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.
Lék: 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.
Komparátor placeba: 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.
Lék: 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.
Lék: Placebo
Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period
Časové okno: 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
Časové okno: Baseline to end of the study (Week 68)
See Adverse Events module for details.
Baseline to end of the study (Week 68)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novartis Pharmaceuticals

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2004

Primární dokončení (Aktuální)

1. března 2008

Dokončení studie (Aktuální)

1. března 2008

Termíny zápisu do studia

První předloženo

18. března 2004

První předloženo, které splnilo kritéria kontroly kvality

19. března 2004

První zveřejněno (Odhad)

22. března 2004

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

11. dubna 2012

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. dubna 2012

Naposledy ověřeno

1. dubna 2012

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CIGE025AIA05

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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