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Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00645086
Collaborator
(none)
465
Enrollment
146
Locations
2
Arms
3.2
Patients Per Site

Study Details

Study Description

Brief Summary

To compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID) in the treatment of acute bacterial exacerbation of chronic bronchitis.

Condition or Disease Intervention/Treatment Phase
  • Drug: clarithromycin extended-release tablets
  • Drug: clarithromycin immediate-release tablets
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
465 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III Comparative Efficacy Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Subjects With Acute Bacterial Exacerbation of Chronic Bronchitis.
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Apr 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Drug: clarithromycin extended-release tablets
5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
Other Names:
  • ABT-268
  • Biaxin
  • clarithromycin

    		•
    Active Comparator: B

    Drug: clarithromycin immediate-release tablets
    7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
    Other Names:
  • ABT-268
  • Biaxin
  • clarithromycin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Response [23 days]

    2. Bacteriologic Response [23 days]

    Secondary Outcome Measures

    1. Adverse events assessment [42 days with follow-up to a satisfactory conclusion]

    2. Physical exam; Vital signs; Use of other medications and supplements [42 days]

    3. Laboratory evaluations [23 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ambulatory subject who does not require intravenous antibiotic therapy.

    • Subject who has a medical history of chronic bronchitis.

    • A history of regular medication use (>=3 consecutive months within the past 2 years) to treat pulmonary disease.

    • Subject must have evidence of pulmonary function test abnormalities.

    • The onset of signs and symptoms of the current exacerbation must occur within 14 days before Evaluation 1.

    Exclusion Criteria:

    • Medical history of hypersensitivity, allergic or adverse reactions to clarithromycin, erythromycin, or any of the macrolide antibiotics.

    • A female who is pregnant or is lactating.

    • Subject who has suspected or known (positive chest radiograph) pneumonia.

    • Subject who has evidence of significant bronchiectasis (by CT) or atelectasis, active tuberculosis or other mycobacterial infection, bullous emphysema, pulmonary embolism, lung abscess, tumor (primary or metastatic) involving the lung, pleural effusion, or cystic fibrosis that could confound the assessment of signs and symptoms of ABECB.

    • Subject who requires parenteral antibiotic therapy.

    • Subject who requires hospitalization for treatment of current episode of ABECB.

    • Subject who has any other infection or condition, which necessitates use of a concomitant systemic antibiotic.

    • Subject who has any underlying condition/disease, which would be likely to interfere with the completion of the course or absorption of study drug therapy or follow-up.

    • Subject who has a severe or complicated lower respiratory tract infection or a severely compromised respiratory status (i.e., oxygen dependent, requiring hospitalization).

    • Known significant renal or hepatic impairment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35235
    2 Birmingham Alabama United States 35242
    3 Columbiana Alabama United States 35051
    4 Hoover Alabama United States 35216
    5 Mobile Alabama United States 36608
    6 Montgomery Alabama United States 36106
    7 Ozark Alabama United States 36360
    8 Glendale Arizona United States 85306
    9 Phoenix Arizona United States 85006
    10 Sun City West Arizona United States 85375
    11 Tucson Arizona United States 85712
    12 Tucson Arizona United States 85746
    13 Camden Arkansas United States 71701
    14 Clovis California United States 93611
    15 Corona California United States 92879
    16 Fountain View California United States 92708
    17 Fresno California United States 93703
    18 Huntington Beach California United States 92647
    19 Lakewood California United States 90712
    20 Pasadena California United States 91105
    21 Rancho Cucamonga California United States 91730
    22 Roseville California United States 95661
    23 San Diego California United States 92103
    24 San Diego California United States 92117
    25 San Diego California United States 92123
    26 San Jose California United States 95128
    27 Sylmar California United States 91342
    28 Temecula California United States 92591
    29 Torrance California United States 90505
    30 Upland California United States 91786
    31 Colorado Springs Colorado United States 80909
    32 Loveland Colorado United States 80538
    33 Wheat Ridge Colorado United States 80033
    34 Waterbury Connecticut United States 06708
    35 Brandon Florida United States 33511
    36 Deland Florida United States 32720
    37 Fort Lauderdale Florida United States 33316
    38 Gainesville Florida United States 32605
    39 Largo Florida United States 33770
    40 Merritt Island Florida United States 32953
    41 Miami Florida United States 33157
    42 Miami Florida United States 33186
    43 New Port Richey Florida United States 34652
    44 Orlando Florida United States 32806
    45 Panama City Florida United States 32405
    46 Tallahassee Florida United States 36078
    47 Tampa Florida United States 33614
    48 Atlanta Georgia United States 30342
    49 Blue Ridge Georgia United States 30513
    50 Fort Gordon Georgia United States 30905
    51 Marietta Georgia United States 30060
    52 Rome Georgia United States 30165-1698
    53 Coeur d'Alene Idaho United States 83814
    54 Chicago Illinois United States 60612
    55 Hines Illinois United States 60141
    56 Orland Park Illinois United States 60462
    57 Elkhart Indiana United States 46514
    58 Evansville Indiana United States 47712
    59 Indianapolis Indiana United States 46254
    60 Wichita Kansas United States 67207
    61 Lexington Kentucky United States 40508
    62 Murray Kentucky United States 42071
    63 Baton Rouge Louisiana United States 70816
    64 Metairie Louisiana United States 70006
    65 New Orleans Louisiana United States 70128
    66 Sunset Louisiana United States 70584
    67 Auburn Maine United States 04210
    68 Chester Maryland United States 21619
    69 Dewitt Michigan United States 48820
    70 Livonia Michigan United States 48152
    71 Saginaw Michigan United States 48602
    72 St. Joseph Michigan United States 49085
    73 Chesterfield Missouri United States 63017
    74 Jefferson City Missouri United States 65109
    75 Springfield Missouri United States 65802
    76 St. Louis Missouri United States 63110-1093
    77 Missoula Montana United States 59804
    78 Omaha Nebraska United States 68134
    79 Blackwood New Jersey United States 08012
    80 Mount Laurel New Jersey United States 08054
    81 Toms River New Jersey United States 08755
    82 West Caldwell New Jersey United States 07007
    83 Astoria New York United States 11102
    84 Bronxville New York United States 10708
    85 Buffalo New York United States 14215
    86 Camillus New York United States 13031
    87 New York New York United States 10016
    88 Greensboro North Carolina United States 27401
    89 Winston-Salem North Carolina United States 27103
    90 Chardon Ohio United States 44024
    91 Mogadore Ohio United States 44260
    92 Toledo Ohio United States 43614
    93 Toledo Ohio United States 43617
    94 Zanesville Ohio United States 43701
    95 Oklahoma City Oklahoma United States 73112
    96 Eugene Oregon United States 97404
    97 Lake Oswego Oregon United States 97035
    98 Medford Oregon United States 97504
    99 Portland Oregon United States 97219
    100 Bensalem Pennsylvania United States 19020
    101 Fleetwood Pennsylvania United States 19522
    102 Philadelphia Pennsylvania United States 19138
    103 Philadelphia Pennsylvania United States 19142
    104 Philadelphia Pennsylvania United States 19148
    105 Ridley Park Pennsylvania United States 19078
    106 Cranston Rhode Island United States 02920
    107 East Providence Rhode Island United States 02914
    108 Bamberg South Carolina United States 29003
    109 Greer South Carolina United States 29651
    110 Simpsonville South Carolina United States 29681
    111 Spartanburg South Carolina United States 29302
    112 Chattanooga Tennessee United States 37404
    113 Clarksville Tennessee United States 37043
    114 Ducktown Tennessee United States 37326
    115 Johnson City Tennessee United States 37601
    116 New Tazewell Tennessee United States 37825
    117 Savannah Tennessee United States 38372
    118 Selmer Tennessee United States 38375
    119 Austin Texas United States 78728
    120 Beaumont Texas United States 77701
    121 Colleyville Texas United States 76034
    122 El Paso Texas United States 79925
    123 Fort Worth Texas United States 76135
    124 San Angelo Texas United States 76904
    125 San Antonio Texas United States 78233
    126 Salt Lake City Utah United States 84102
    127 Christianburg Virginia United States 24073
    128 Mechanicsville Virginia United States 23111
    129 Newport News Virginia United States 23606
    130 Richmond Virginia United States 23226
    131 Spokane Washington United States 99204
    132 Spokane Washington United States 99207
    133 Spokane Washington United States 99216
    134 Milwaukee Wisconsin United States 53125
    135 New Berlin Wisconsin United States 53151
    136 Coquitlam British Columbia Canada V3K 3P4
    137 Winnipeg Manitoba Canada R3R 0C5
    138 Kitchener Ontario Canada N2C 2N9
    139 Markham Ontario Canada L6B 1A1
    140 Mississauga Ontario Canada L5M 2V8
    141 Scarborough Ontario Canada M1B 4Z8
    142 Toronto Ontario Canada M9W 4L6
    143 Sherbrooke Quebec Canada J1J 2B8
    144 Ste-Foy Quebec Canada G1V 4G5
    145 Saskatoon Saskatchewan Canada S7H 5M3
    146 San Juan Puerto Rico 00921-3201

    Sponsors and Collaborators

    • Abbott

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00645086
    Other Study ID Numbers:
    • M02-472
    First Posted:
    Mar 27, 2008
    Last Update Posted:
    Mar 27, 2008
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Bronchitis
    Bronchitis, Chronic
    Acute Disease
    Clarithromycin

    Study Results

    No Results Posted as of Mar 27, 2008