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

9 de abril de 2012 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Real)

628

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

6 anos a 11 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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.
Medicamento: 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.
Comparador de Placebo: 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.
Medicamento: 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.
Medicamento: Placebo
Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period
Prazo: 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
Prazo: Baseline to end of the study (Week 68)
See Adverse Events module for details.
Baseline to end of the study (Week 68)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2004

Conclusão Primária (Real)

1 de março de 2008

Conclusão do estudo (Real)

1 de março de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

18 de março de 2004

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de março de 2004

Primeira postagem (Estimativa)

22 de março de 2004

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

11 de abril de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de abril de 2012

Última verificação

1 de abril de 2012

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CIGE025AIA05

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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