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

9 aprile 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

628

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 11 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Droga: 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.
Comparatore 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.
Droga: 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.
Droga: Placebo
Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period
Lasso di tempo: 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
Lasso di tempo: Baseline to end of the study (Week 68)
See Adverse Events module for details.
Baseline to end of the study (Week 68)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2004

Completamento primario (Effettivo)

1 marzo 2008

Completamento dello studio (Effettivo)

1 marzo 2008

Date di iscrizione allo studio

Primo inviato

18 marzo 2004

Primo inviato che soddisfa i criteri di controllo qualità

19 marzo 2004

Primo Inserito (Stima)

22 marzo 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 aprile 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 aprile 2012

Ultimo verificato

1 aprile 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CIGE025AIA05

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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