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Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists (eXplore)

12 december 2012 uppdaterad av: Novartis Pharmaceuticals

A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Trial to Explore the Effects of 78 Weeks Omalizumab Treatment Given as Add on Therapy on Markers of Airway Inflammation and Remodeling in Patients With Moderate to Severe Persistent Allergic Asthma Receiving Inhaled Corticosteroids and Long Acting Beta-agonists

This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

36

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Montpellier, Frankrike, 34059
        • Novartis Investigative Site
  • Förenta staterna
    • Colorado
      • Denver, Colorado, Förenta staterna, 80206
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, Förenta staterna, 63110
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Förenta staterna, 19140
        • Novartis Investigative Site
    • Texas
      • Galveston, Texas, Förenta staterna, 77555-1083
        • Novartis Investigative Site
  • Kanada
      • Quebec, Kanada, G1V 4G5
        • Novartis Investigative Site
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4N1
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Kanada, H2X 2P4
        • Novartis Investigative Site
  • Nederländerna
      • Leiden 2333 ZA, Nederländerna, 2333
        • Novartis Investigative Site
  • Storbritannien
      • Glasgow - Scotland, Storbritannien, G12 OYN
        • Novartis Investigative Site
      • Manchester, Storbritannien, M20 8LR
        • Novartis Investigative Site
      • Southampton, Storbritannien, SO16 6YD
        • Novartis Investigative Site
  • Sverige
      • Lund, Sverige, SE-221 85
        • Novartis Investigative Site
  • Tyskland
      • Mainz, Tyskland, D-55101
        • Novartis Investigative Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day BDP or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
  • With a body weight between 20 and 150kg and a serum total IgE level of 30 to 700 IU/mL
  • With ≥2% eosinophilia in induced sputum at screening
  • With post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% predicted
  • With a positive skin prick test (diameter of wheal ≥ 3 mm) or RAST test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.

Exclusion Criteria:

  • Patients who've had an asthma exacerbation during the 4 weeks prior to randomization
  • Current smokers, stopped smoking within the last 12 months or have a smoking history of >10 pack years
  • History of severe allergy to food or drugs
  • Previous treatment with omalizumab
  • Any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator

Other protocol-defined inclusion/exclusion criteria applied.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: omalizumab
Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
Läkemedel: omalizumab at a dose of 0.016mg/kg/IU/mL
Placebo-jämförare: Placebo
Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
Läkemedel: Placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)
Tidsram: Baseline, at end of week 78
The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Baseline, at end of week 78

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples
Tidsram: Baseline, at end of week 78
The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Baseline, at end of week 78
Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples
Tidsram: Baseline, at end of week 78
The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Baseline, at end of week 78
Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples
Tidsram: Baseline, at end of week 78
The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Baseline, at end of week 78
Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy
Tidsram: 78 weeks
78 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Samarbetspartners

Genentech, Inc.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2008

Primärt slutförande (Faktisk)

1 november 2011

Avslutad studie (Faktisk)

1 november 2011

Studieregistreringsdatum

Först inskickad

30 april 2008

Först inskickad som uppfyllde QC-kriterierna

1 maj 2008

Första postat (Uppskatta)

2 maj 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

18 januari 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 december 2012

Senast verifierad

1 november 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CIGE025A2432
  • 2007-004653-29 (EudraCT-nummer)

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