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The efficacy and safety of omalizumab in patients with severe persistent asthma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about The efficacy and safety of omalizumab in patients with severe persistent asthma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The efficacy and safety of omalizumab in patients with severe persistent asthma Clinical research trials and The efficacy and safety of omalizumab in patients with severe persistent asthma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like The efficacy and safety of omalizumab in patients with severe persistent asthma. The efficacy and safety of omalizumab in patients with severe persistent asthma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a The efficacy and safety of omalizumab in patients with severe persistent asthma clinical trial. Human subjects often get the best healthcare available for their The efficacy and safety of omalizumab in patients with severe persistent asthma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The efficacy and safety of omalizumab in patients with severe persistent asthma  The efficacy and safety of omalizumab in patients with severe persistent asthma
The efficacy and safety of omalizumab in patients with severe persistent asthma
For Condition: Asthma
Status: No longer recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: To determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 12 Years/75 Years
Genders: Both
Protocol Entry Criteria: --with the diagnosis of allergic asthma >1 year duration who, in addition to the standards of the American Thoracic Society (ATS) meet the following criteria: --with a positive prick skin test (diameter of wheal > 3 mm) to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 5 years or at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. A RAST test may be performed for patients with a borderline skin prick test result. --with total serum IgE level 30 to 700 IU/ml. --demonstrating 12% increase in FEV1 over baseline value within 30 minutes of taking up to 4 puffs salbutamol (albuterol) or nebulized salbutamol up to 5mg (or equivalent of alternative B-2 agonist) documented within the past year, at screening, during the run-in period or at baseline prior to randomization. --with FEV1 40-80% of predicted normal value for the patient (demonstrable at least 6 hours after short acting B-2 agonist use or 12 hours after long acting B-2 agonist use) at baseline. --who have either experienced at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year. or: --been admitted to hospital (including intensive care unit) or received emergency room (including urgent care centers) treatment in the past 12 months for an asthma exacerbation, which in accordance with the GINA guidelines met all of the following criteria for a severe exacerbation: 1. PEF or FEV1< 60% of predicted/personal best, or patient is too breathless to provide PEF. 2. No improvement after initial treatment and therefore requiring repeated treatment with inhaled B-2 agonist (high dose, spacer or nebulized). 3. Requiring treatment with systemic corticosteroids --receiving high dose inhaled corticosteroid (at least 1000ug beclomethasone dipropionate or equivalent) and a regular inhaled long acting B-2 agonist for at least 3 months prior to screening and prior to at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year or the severe asthma exacerbation requiring the hospitalization/ER visit. --who are receiving an ICS dosage > 1000ug beclomethasone dipropionate or equivalent and a regular inhaled long acting B-2 agonist for the last 4 weeks of the run-in period and at randomization (to be maintained throughout the study). --whose asthma medication remains unchanged in the final 4 weeks of the run-in period (to be maintained throughout the study). --with evidence of poor asthma symptom control at screening (based on patient history) and during the 4 weeks immediately prior to baseline.
Total Enrollment: 400
Location and Contact Information:
Dr. Mathias Kopp
Freiburg, , 79104
Germany
Dr. Joan Gluck
Miami, Florida, 33176
United States
Dr. Karl-Otto Steinmetz
Darmstadt, , 64287
Germany
Dr. OA Khair
Birmingham, , B18 7QH
United Kingdom
Prof. Morice
Cottingham, , HU165JQ
United Kingdom
Dr. Lieske Kuitert
London, , E1 1BB
United Kingdom
Dr. Noeleen Foley
Bath, Avon, BA1 3NG
United Kingdom
Dr. Elizabeth Powell
Brampton, Ontario, L6W 3P8
Canada
Prof. Humbert
Clamart, , 92141
France
Dr. Jorge Salas
Mexico, D.F., 14080
Mexico
Prof. Manuel Tunon de Lara
Pessac, , 33604
France
Dr. Juan Merida
Mexicali, Baja California, 21100
Mexico
Dr. Stanley Galant
Orange, California, 92868
United States
Dr. Peter B. Boggs
Shreveport, Louisiana, 71104
United States
Dr. Wolfgang Zachgo
Geesthacht, , 21502
Germany
Dr. Paul Chervinsky
Dartmouth, New Hampshire, 02747
United States
Dr. C. Coeck
Mechelen, , 2800
Belgium
Dr. Clare LaRoche
Bury St. Edmunds, Suffolk, IP33 2QZ
United Kingdom
Dr. Alyn Morice
Cottingham, Hull,
United Kingdom
Dr. Ronald Ferdman
Los Angeles, California, 90027
United States
Dr. Pal Magyar
Budapest, , H 1125
Hungary
Dr. Jane Gravil
Paisley, , PA2 9PN
United Kingdom
Dr. Ross Thomas
Omaha, Nebraska, 68114
United States
Prof. Chilvers
Cambridge, , CB2 2QQ.
United Kingdom
Dr. David L. Gossage
Knoxville, Tennessee, 37922
United States
Dr. Illeen Gilbert
Cleveland, Ohio, 44109
United States
Dr. Moises Simpser
Miami, Florida, 33155
United States
Dr. Cornelius Kellner
Hagen, , 58095
Germany
Dr. Alfredo Potena
Ferrara, , 44100
Italy
Dr. Anthony Rooklin
Upland, Pennsylvania, 19013
United States
Dr. Steve O'Hickey
Worcester, , WR5 1DD
United Kingdom
Dr. Pedro Cabrera
Las Palmas, , 35020
Spain
Dr. Innes
Ipswich, Suffolk, IP4 5PD
United Kingdom
Dr. Jeffrey Wald
Overland Park, Kansas, 66210
United States
Dr. A. Rubinfeld
Parkville, Victoria, 3050
Australia
Dr. Neville Berkman
Jerusalem, , 91120
Israel
Prof. N. Suttorp
Berlin, , 13353
Germany
Dr. Peter Kardos
Frankfurt, , 60318
Germany
Dr. William Berger
Mission Viejo, California, 92691
United States
Dr. Raymond Slavin
St. Louis, Missouri, 63104
United States
Dr. Jonathan Matz
Baltimore, Maryland, 21236
United States
Dr. Kevin Kelley
Milwaukee, Wisconsin, 53226
United States
Dr. J Grant
Galveston, Texas, 77555
United States
Dr. Trevor Rogers
Doncaster, , DN2 5LT
United Kingdom
Dr. Tony Tanus
Bakersfield, California, 93301
United States
Dr. Issac Melamed
Englewood, Colorado, 80112
United States
Dr. AC Roldaan
Den Haag, CH, 2545
Netherlands
Prof. Philip Bardin
Clayton, Victoria, 3168
Australia
Dr. Hans-Wolf Baenkler
Erlangen, , 91023
Germany
Drs. PB Luursema
Zutphen, BA, 7207
Netherlands
Dr. GW Canonica
Genova, , 16132
Italy
Prof. Pal Kraszko
Deszk, , 6772
Hungary
Dr. A. Boomstra
Amsterdam, HV, 1081
Netherlands
Dr. Stephen Tilles
Seattle, Washington, 98105
United States
Dr. Gordon Sussman
Toronto, Ontario, M4V 1R2
Canada
Dr. Alan Heller
San Jose, California, 95128
United States
Prof. Norbert Krug
Hannover, , 30625
Germany
Dr. Richard Nowak
Detroit, Michigan, 48202
United States
Dr. Sam Lim
Concord, New South Wales, 2139
Australia
Dr. Alicia Ramirez
Monterrey, , 64360
Mexico
Dr. Robyn Levy
Atlanta, Georgia, 30342
United States
Dr. Juan Jesus Garcia
Malaga, , 29010
Spain
Dr. Eric Lang
Miami, Florida, 33125
United States
Dr. William Busse
Madison, Wisconsin, 53792
United States
Dr. Britton
Surrey, 0PZ, KT16
United Kingdom
Prof. L. Dupont
Leuven, , 3000
Belgium
Dr. Robert Aris
Chapel Hill, North Carolina, 27599
United States
Dr. Kai Michael Beeh
Mainz, , 55131
Germany
Dr. PL Paggiaro
Pisa, , 56124
Italy
Dr. Charles P. Andrews
San Antonio, Texas, 78229
United States
Dr. Edward Lisberg
River Forest, Illinois, 60305
United States
Dr. Jeffrey Simons
Riverside, California, 92501
United States
Dr. A. Aminian
Fresno, California, 93720
United States
Dr. Juan Martinez
Koeln, , 50672
Germany
Dr. Stacey Jones
Little Rock, Arkansas, 72202
United States
Dr. Pierre Larivee
Fleurimont, Quebec, J1H 5N4
Canada
Dr. Anjuli Nayak
Bloomington, Illinois, 61704
United States
Dr. Eugene Bleecker
Winston Salem, North Carolina, 27517
United States
Dr. Arthur Degraff
Hartford, Connecticut, 06106
United States
Dr. Alvar Agusti
Palma de Mallorca, , 07014
Spain
Dr. Timothy Moriarty
Panama City, Florida, 32405
United States
Dr. M Plit
Johannesburg, , 2193
South Africa
Prof. Pauli
Strasbourg, , 67091
France
Dr. Ronald Olivenstein
Montreal, Quebec, H2X 2P4
Canada
Dr. M. van der Linden
Berea, , 4001
South Africa
Dr. Tony Tannus
Bakersfield, California, 93301
United States
Dr. Robert Wolfe
Los Angeles, California, 90048
United States
Dr. K. Rajakualsingham
Homerton Row, Hackney, E9 6SR
United Kingdom
Dr. J. Grobelaar
CAPE TOWN, , 7405
South Africa
Dr. Donald Senter
Garland, Texas, 75042
United States
Dr. Pierre Zuck
France, , 57038
France
Dr. David Halpin
Exeter, Devon, EX2 5DW
United Kingdom
Dr. David Valacer
New York City, New York, 10021
United States
Dr. Brian O'Connor
London, , E2 9UX
United Kingdom
Prof. Stefan Zielen
Frankfurt, , 60590
Germany
Dr. Pascal Chanez
Montpellier, , 34059
France
Prof. C. Pison
Grenoble, , 38043
France
Dr. FJJ van den Elshout
ARNHEM, AD, 6815
Netherlands
Dr. James Wolf
San Jose, California, 95117-1780
United States
Dr. Gene Colice
Washington D.C., District of Columbia, 20010
United States
Prof. Raffaele Scicchitano
Adelaide, South Australia, 5000
Australia
Dr. Joan Serra
Barcelona, , 08500
Spain
Dr. Andrew E. Davidson
Charleston, South Carolina, 29414
United States
Dr. John Condemi
Rochester, New York, 14518
United States
Dr. Arden Levy
Spartanburg, South Carolina, 29307
United States
Dr. Ellis
Gorleston, Great Yarmouth, NR31 6LA
United Kingdom
Dr. Roland Balzer
Gummersbach, , 51643
Germany
Dr. Richard Wasserman
Dallas, Texas, 75230
United States
Dr. Juan Sienra
Mexico, DF, 06720
Mexico
Dr. Jacques Hebert
Ste Foy, Quebec, G1V 4M6
Canada
Dr. Jonathan Bernstein
Cincinnati, Ohio, 45231
United States
Dr. Michael Marcus
Staten Island, New York, 10304
United States
Dr. Leonard Bielory
Newark, New Jersey, 07103
United States
Dr. H. Arievich
Berlin, , 14059
Germany
Dr. Wolfram Feussner
Kassel, , 34117
Germany
Dr. Reza Maleki-Yazdi
Toronto, Ontario, M5S2A5
Canada
Dr. William Yang
Ottawa, Ontario, K1Y 4G2
Canada
Prof. Paul Corris
Newcastle upon Tyne, , NE7 7DN
United Kingdom
Dr. Jonathan Berstein
Cincinnati, Ohio, 45231
United States
Prof. Crestani
Paris, , 75877
France
Dr. Harrison
Colney, Norwich, NR4 7UY
United Kingdom
Dr. A. Aminian
Fresno, California, 93720
United States
Dr. James Tracy
Omaha, Nebraska, 68124
United States
Dr. Jonathan Corren
Los Angeles, California, 90025
United States
Dr. Peter Middleton
Westmead, New South Wales, 2145
Australia
Dr. John Jeppson
Meridian, Idaho, 83642
United States
Dr. John Bastian
San Diego, California, 92123
United States
Dr. Anthony DeMeo
Walnut Creek, California, 94598
United States
Dr. Phillip Korenblat
St. Louis, Missouri, 63141
United States
Dr. L-P Boulet
Sainte-Foy, Quebec, G1V 4G5
Canada
Dr. Dennis M. Bowie
Halifax, Nova Scotia, B3H 3A7
Canada
Prof. Stephen Holgate
Southampton, , SO16 6YD
United Kingdom
Dr. Abraham Eliraz
Rehovot, , 76100
Israel
Dr. Dennis Ledford
Tampa, Florida, 33613
United States
Prof. W. DeBacker
Edegem, , 2650
Belgium
Dr. Jeffrey Blumer
Cleveland, Ohio, 44106-6010
United States
Prof. Charles Mitchell
Woolloongabba, Queensland, 4102
Australia
Dr. R. Peche
Montigny-le-Tilleul, , 6110
Belgium
Dr. Jose Conde
Sevilla, , 41071
Spain
Dr. Santiago Quirce
Madrid, , 28040
Spain
Prof. Ayres
Birmingham, , B9 5SST
United Kingdom
Drs. JPHM Creemers
Eindhoven, , 5623
Netherlands
Dr. Arshad
Southampton, , SO16 6YD
United Kingdom
Dr. William Massey
Birmingham, Alabama, 35213
United States
Drs. SJM Gans
Harderwijk, DG, 3844
Netherlands
Dr. Neil Barnes
London, , E2 9UX
United Kingdom
Dr. Donald Kennerly
Dallas, Texas, 75246
United States
Dr. Dante Hernandez
Guadalajara, Jalisco, 44600
Mexico
Dr. Krishna Pudi
Simpsonville, South Carolina, 29681
United States
Dr. Benjamin Interiano
Houston, Texas, 77074
United States
Prof. Gyorgy Boszormnyi Nagy
Budapest, , 1159
Hungary
Drs. EFL Dubois
The Hague, CX, 2275
Netherlands
Dr. Andrew Greening
Edinburgh, , EH4 2XU
United Kingdom
Prof. Philip Thompson
Nedlands, Western Australia, 6009
Australia
Dr. Lars Gronke
Hamburg, , 20535
Germany
Dr. Gyula Berta
Mosdos, , 7257
Hungary
Prof. Chung
London, , SW3 6LY
United Kingdom
Dr. Arif Seyal
Rancho Cordova, California, 95670
United States
Dr. Hector Verea
La Coruna, , 15006
Spain
Dr. Stefano Centanni
Milano, , 20142
Italy
Dr. Cameron Hunter
Peterborough, , PE3 6DA
United Kingdom
Dr. Christopher Smith
Ithaca, New York, 14850
United States
Dr. Andrew Martin
New Brunswick, New Jersey, 08903
United States
Dr. Victor Sobradilla
Baracaldo, , 48903
Spain
Dr. A. Foden
CAPE TOWN, , 7500
South Africa
Dr. Robert Niven
Wythenshawe, Manchester, M23 9LT
United Kingdom
Dr. Larry Wayne Williams
Durham, North Carolina, 27710
United States
Dr. Anna Cistero
Barcelona, , 08017
Spain
Dr. Lugi Zucchi
Reggio nell Emilia, , 42100
Italy
Dr. Joan Kilian
Pretoria, , 0040
South Africa
Additional Information:
Study ID Numbers: CIGE025A2306;
Study Start Date: December 2001
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046748
Other Asthma Studies:
1. Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
2. Study of Daclizumab in Patients with Chronic, Persistent Asthma
3. Epidemiology of Airway Responsiveness
4. T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma
5. Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma
Related Studies:
Other Asthma Clinical Trials
Other Clinical Trials
Other La Coruna Clinical Trials
The efficacy and safety of omalizumab in patients with severe persistent asthma
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