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Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00048009
Collaborator
(none)
91
Locations
15.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical research sites in the US, Mexico, and Canada. Study participants will have a number of visits to a research site over approximately a 4-month period.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dual Integrin Antagonist
 Phase 2

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Actual Study Start Date :
Oct 25, 2002
Actual Primary Completion Date :
Feb 2, 2004
Actual Study Completion Date :
Feb 2, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Persistent asthma for more than one year

    • Current treatment for asthma with short acting inhaled beta 2 agonists (such as albuterol) only

    • In good health ad demonstrated by medical history and physical exam

    • Negative urine pregnancy test

    • Commitment to use two forms of effective contraception simultaneously throughout the study duration and for one month after discontinuing therapy

    Exclusion Criteria:

    • Asthma necessitating treatment with inhaled corticosteroids for at least one month before the start of the study

    • History of severe asthma necessitating the use of oral/injectable corticosteroids within the last 2 months and/and or two bursts in the last year

    • Undergoing allergy shots unless on a stable maintenance dose for three months before the start of the study

    • History of chronic pulmonary diseases other than asthma

    • Treatment of conditions other than asthma with oral corticosteroids within one month of the start of the study

    • Current tobacco use

    • Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)

    • History or evidence of drug or alcohol abuse

    • Diagnosis or evidence of an infectious illness within one month of Visit 1

    • Clinically significant diseases as assessed by the study doctor

    • Participation in another clinical study with an experimental drug within one month of start of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scottsdale Arizona United States 85251
    2 Huntington Beach California United States 92647
    3 Long Beach California United States 90806
    4 Los Angeles California United States 90025
    5 Los Angeles California United States 90095-1690
    6 Palmdale California United States 93551
    7 San Diego California United States 92103
    8 San Diego California United States 92120
    9 San Diego California United States 92123
    10 San Jose California United States 95128
    11 Walnut Creek California United States 94598
    12 Denver Colorado United States 80206
    13 Denver Colorado United States 80230
    14 Louisville Colorado United States 80027
    15 Wheat Ridge Colorado United States 80033
    16 Hartford Connecticut United States 06106
    17 Tallahassee Florida United States 32308
    18 Tamarac Florida United States 33321
    19 Tampa Florida United States 33609
    20 Tampa Florida United States 33613
    21 Atlanta Georgia United States 30309
    22 Savannah Georgia United States 31406
    23 Chicago Illinois United States 60637-1470
    24 Normal Illinois United States 61761
    25 River Forest Illinois United States 60305
    26 Indianapolis Indiana United States 46208
    27 Iowa City Iowa United States 52240
    28 Lenexa Kansas United States 66219
    29 Metairie Louisiana United States 70006
    30 North Dartmouth Massachusetts United States 02745
    31 Minneapolis Minnesota United States 55402
    32 Saint Louis Missouri United States 63141
    33 Missoula Montana United States 59804
    34 Omaha Nebraska United States 68114
    35 Las Vegas Nevada United States 89104
    36 Cherry Hill New Jersey United States 08003
    37 Princeton New Jersey United States 08540
    38 Teaneck New Jersey United States 07666
    39 Farmingdale New York United States 11735
    40 Rochester New York United States 14618
    41 Rockville Centre New York United States 11570
    42 Elizabeth City North Carolina United States 27909
    43 Canton Ohio United States 44718
    44 Cincinnati Ohio United States 45231
    45 Medford Oregon United States 97504
    46 Portland Oregon United States 97213
    47 Easton Pennsylvania United States 18045
    48 Philadelphia Pennsylvania United States 19115
    49 Philadelphia Pennsylvania United States 19140
    50 Upland Pennsylvania United States 19013
    51 Providence Rhode Island United States 02906
    52 Charleston South Carolina United States 29407
    53 Charleston South Carolina United States 29425
    54 Austin Texas United States 78750
    55 Dallas Texas United States 75231
    56 Dallas Texas United States 75240
    57 El Paso Texas United States 79925
    58 San Antonio Texas United States 78229
    59 Sugar Land Texas United States 77478
    60 Murray Utah United States 84107
    61 Kirkland Washington United States 98034
    62 Seattle Washington United States 98105
    63 Spokane Washington United States 99202
    64 Tacoma Washington United States 98405
    65 Wenatchee Washington United States 98801
    66 Morgantown West Virginia United States 26505
    67 Madison Wisconsin United States 53792-9988
    68 Milwaukee Wisconsin United States 53209
    69 Adelaide Australia 5000
    70 Brisbane Australia 4102
    71 Melbourne Australia 3050
    72 Perth Australia 6009
    73 Sydney Australia 2139
    74 Woodville Australia 5011
    75 Vancouver British Columbia Canada V5Z 1M9
    76 Hamilton Ontario Canada L8N 4A6
    77 Toronto Ontario Canada M5S 2A5
    78 Toronto Ontario Canada M6H 3M2
    79 Montreal Quebec Canada H4J 1C5
    80 Quebec City Quebec Canada O1V 4G5
    81 Chihuahua Mexico 31000
    82 Guadalajara Mexico 44600
    83 Merida Mexico
    84 Mexico City Mexico 06700
    85 Mexico City Mexico 14050
    86 Mexico, Df Mexico 06720
    87 Mexico Mexico 14080
    88 Monterrey Mexico 64000
    89 Monterrey Mexico 64710
    90 Puebla Mexico 72000
    91 Ponce Puerto Rico 00732

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT00048009
    Other Study ID Numbers:
    • BA16631
    First Posted:
    Oct 25, 2002
    Last Update Posted:
    Jun 19, 2017
    Last Verified:
    Feb 1, 2017

    Study Results

    No Results Posted as of Jun 19, 2017