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- Klinische proef NCT00670930
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 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
36
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Quebec, Canada, G1V 4G5
- Novartis Investigative Site
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Canada, H2X 2P4
- Novartis Investigative Site
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Mainz, Duitsland, D-55101
- Novartis Investigative Site
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Montpellier, Frankrijk, 34059
- Novartis Investigative Site
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Leiden 2333 ZA, Nederland, 2333
- Novartis Investigative Site
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Glasgow - Scotland, Verenigd Koninkrijk, G12 OYN
- Novartis Investigative Site
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Manchester, Verenigd Koninkrijk, M20 8LR
- Novartis Investigative Site
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Southampton, Verenigd Koninkrijk, SO16 6YD
- Novartis Investigative Site
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Colorado
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Denver, Colorado, Verenigde Staten, 80206
- Novartis Investigative Site
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Missouri
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St. Louis, Missouri, Verenigde Staten, 63110
- Novartis Investigative Site
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
- Novartis Investigative Site
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Novartis Investigative Site
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Philadelphia, Pennsylvania, Verenigde Staten, 19140
- Novartis Investigative Site
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Texas
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Galveston, Texas, Verenigde Staten, 77555-1083
- Novartis Investigative Site
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Lund, Zweden, SE-221 85
- Novartis Investigative Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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Placebo-vergelijker: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)
Tijdsspanne: Baseline, at end of week 78
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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.
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Baseline, at end of week 78
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples
Tijdsspanne: Baseline, at end of week 78
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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.
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Baseline, at end of week 78
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Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples
Tijdsspanne: Baseline, at end of week 78
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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.
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Baseline, at end of week 78
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Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples
Tijdsspanne: Baseline, at end of week 78
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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.
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Baseline, at end of week 78
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Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy
Tijdsspanne: 78 weeks
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78 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2008
Primaire voltooiing (Werkelijk)
1 november 2011
Studie voltooiing (Werkelijk)
1 november 2011
Studieregistratiedata
Eerst ingediend
30 april 2008
Eerst ingediend dat voldeed aan de QC-criteria
1 mei 2008
Eerst geplaatst (Schatting)
2 mei 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
18 januari 2013
Laatste update ingediend die voldeed aan QC-criteria
12 december 2012
Laatst geverifieerd
1 november 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CIGE025A2432
- 2007-004653-29 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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