Clincosm LogoSign in Get a demo

Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00540163
Collaborator
(none)
1,296
Enrollment
177
Locations
7.3
Patients Per Site

Study Details

Study Description

Brief Summary

This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study Design:

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1296 participants
    Time Perspective:
    Prospective
    Official Title:
    Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).
    Study Start Date :
    Apr 1, 2007
    Actual Primary Completion Date :
    Nov 1, 2007

    Outcome Measures

    Primary Outcome Measures

    1. The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram [6 weeks]

    Secondary Outcome Measures

    1. The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram [6 weeks]

    Eligibility Criteria

    Criteria

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

    Men or women with COPD and a thoracic gas volume (TGV) of < 140% at rest, MRC value of 2 or more.

    Exclusion Criteria:

    • Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies.

    • Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boehringer Ingelheim Investigational Site Amberg Germany
    2 Boehringer Ingelheim Investigational Site Anklam Germany
    3 Boehringer Ingelheim Investigational Site Aschau Germany
    4 Boehringer Ingelheim Investigational Site Auerbach Germany
    5 Boehringer Ingelheim Investigational Site Augsburg Germany
    6 Boehringer Ingelheim Investigational Site Backnang Germany
    7 Boehringer Ingelheim Investigational Site Bad Doberan Germany
    8 Boehringer Ingelheim Investigational Site Bad Lippspringe Germany
    9 Boehringer Ingelheim Investigational Site Bad Oeynhausen Germany
    10 Boehringer Ingelheim Investigational Site Bad Soden Germany
    11 Boehringer Ingelheim Investigational Site Bad Wörishofen Germany
    12 Boehringer Ingelheim Investigational Site Beelitz Germany
    13 Boehringer Ingelheim Investigational Site Bensheim Germany
    14 Boehringer Ingelheim Investigational Site Bergisch Gladbach Germany
    15 Boehringer Ingelheim Investigational Site Berlin Germany
    16 Boehringer Ingelheim Investigational Site Biberach Germany
    17 Boehringer Ingelheim Investigational Site Bochum Germany
    18 Boehringer Ingelheim Investigational Site Bonn Germany
    19 Boehringer Ingelheim Investigational Site Braunschweig Germany
    20 Boehringer Ingelheim Investigational Site Breisach Germany
    21 Boehringer Ingelheim Investigational Site Bremen Germany
    22 Boehringer Ingelheim Investigational Site Bremerhaven Germany
    23 Boehringer Ingelheim Investigational Site Bruchsal Germany
    24 Boehringer Ingelheim Investigational Site Buchholz Germany
    25 Boehringer Ingelheim Investigational Site Bünde Germany
    26 Boehringer Ingelheim Investigational Site Calw Germany
    27 Boehringer Ingelheim Investigational Site Castrop-Rauxel Germany
    28 Boehringer Ingelheim Investigational Site Celle Germany
    29 Boehringer Ingelheim Investigational Site Chemnitz Germany
    30 Boehringer Ingelheim Investigational Site Coburg Germany
    31 Boehringer Ingelheim Investigational Site Cottbus Germany
    32 Boehringer Ingelheim Investigational Site Darmstadt Germany
    33 Boehringer Ingelheim Investigational Site Dillenburg Germany
    34 Boehringer Ingelheim Investigational Site Dinslaken Germany
    35 Boehringer Ingelheim Investigational Site Dortmund Germany
    36 Boehringer Ingelheim Investigational Site Dresden Germany
    37 Boehringer Ingelheim Investigational Site Duisburg Germany
    38 Boehringer Ingelheim Investigational Site Düren Germany
    39 Boehringer Ingelheim Investigational Site Düsseldorf Germany
    40 Boehringer Ingelheim Investigational Site Eisenhüttenstadt Germany
    41 Boehringer Ingelheim Investigational Site Emden Germany
    42 Boehringer Ingelheim Investigational Site Erbach Germany
    43 Boehringer Ingelheim Investigational Site Erfurt Germany
    44 Boehringer Ingelheim Investigational Site Essen Germany
    45 Boehringer Ingelheim Investigational Site Esslingen Germany
    46 Boehringer Ingelheim Investigational Site Euskirchen Germany
    47 Boehringer Ingelheim Investigational Site Fellbach Germany
    48 Boehringer Ingelheim Investigational Site Flensburg Germany
    49 Boehringer Ingelheim Investigational Site Forchheim Germany
    50 Boehringer Ingelheim Investigational Site Frankfurt Germany
    51 Boehringer Ingelheim Investigational Site Freising Germany
    52 Boehringer Ingelheim Investigational Site Fürstenfeldbruck Germany
    53 Boehringer Ingelheim Investigational Site Fürth Germany
    54 Boehringer Ingelheim Investigational Site Gadebusch Germany
    55 Boehringer Ingelheim Investigational Site Geilenkirchen Germany
    56 Boehringer Ingelheim Investigational Site Gelnhausen Germany
    57 Boehringer Ingelheim Investigational Site Gelsenkirchen Germany
    58 Boehringer Ingelheim Investigational Site Germering Germany
    59 Boehringer Ingelheim Investigational Site Gießen Germany
    60 Boehringer Ingelheim Investigational Site Gifhorn Germany
    61 Boehringer Ingelheim Investigational Site Gotha Germany
    62 Boehringer Ingelheim Investigational Site Greiz Germany
    63 Boehringer Ingelheim Investigational Site Gummersbach Germany
    64 Boehringer Ingelheim Investigational Site Göppingen Germany
    65 Boehringer Ingelheim Investigational Site Gütersloh Germany
    66 Boehringer Ingelheim Investigational Site Halberstadt Germany
    67 Boehringer Ingelheim Investigational Site Halle Germany
    68 Boehringer Ingelheim Investigational Site Hamburg Germany
    69 Boehringer Ingelheim Investigational Site Hameln Germany
    70 Boehringer Ingelheim Investigational Site Hamm Germany
    71 Boehringer Ingelheim Investigational Site Hannover Germany
    72 Boehringer Ingelheim Investigational Site Heidelberg Germany
    73 Boehringer Ingelheim Investigational Site Heilbronn Germany
    74 Boehringer Ingelheim Investigational Site Herne Germany
    75 Boehringer Ingelheim Investigational Site Hilden Germany
    76 Boehringer Ingelheim Investigational Site Hildesheim Germany
    77 Boehringer Ingelheim Investigational Site Hoyerswerda Germany
    78 Boehringer Ingelheim Investigational Site Ibbenbüren Germany
    79 Boehringer Ingelheim Investigational Site Ingolstadt Germany
    80 Boehringer Ingelheim Investigational Site Iserlohn Germany
    81 Boehringer Ingelheim Investigational Site Kaiserslautern Germany
    82 Boehringer Ingelheim Investigational Site Kamen Germany
    83 Boehringer Ingelheim Investigational Site Karlsruhe Germany
    84 Boehringer Ingelheim Investigational Site Kaufbeuren Germany
    85 Boehringer Ingelheim Investigational Site Kempten Germany
    86 Boehringer Ingelheim Investigational Site Kevelaer Germany
    87 Boehringer Ingelheim Investigational Site Kiel Germany
    88 Boehringer Ingelheim Investigational Site Konstanz Germany
    89 Boehringer Ingelheim Investigational Site Krefeld Germany
    90 Boehringer Ingelheim Investigational Site Köln Germany
    91 Boehringer Ingelheim Investigational Site Landshut Germany
    92 Boehringer Ingelheim Investigational Site Langenfeld Germany
    93 Boehringer Ingelheim Investigational Site Leipzig Germany
    94 Boehringer Ingelheim Investigational Site Limburg Germany
    95 Boehringer Ingelheim Investigational Site Lindenberg Germany
    96 Boehringer Ingelheim Investigational Site Linz Germany
    97 Boehringer Ingelheim Investigational Site Lippstadt Germany
    98 Boehringer Ingelheim Investigational Site Ludwigsburg Germany
    99 Boehringer Ingelheim Investigational Site Lörrach Germany
    100 Boehringer Ingelheim Investigational Site Lüdenscheid Germany
    101 Boehringer Ingelheim Investigational Site Lüneburg Germany
    102 Boehringer Ingelheim Investigational Site Magdeburg Germany
    103 Boehringer Ingelheim Investigational Site Mainz Germany
    104 Boehringer Ingelheim Investigational Site Marburg Germany
    105 Boehringer Ingelheim Investigational Site Markkleeberg Germany
    106 Boehringer Ingelheim Investigational Site Memmingen Germany
    107 Boehringer Ingelheim Investigational Site Menden Germany
    108 Boehringer Ingelheim Investigational Site Minden Germany
    109 Boehringer Ingelheim Investigational Site Moers Germany
    110 Boehringer Ingelheim Investigational Site Mönchengladbach Germany
    111 Boehringer Ingelheim Investigational Site Mühldorf Germany
    112 Boehringer Ingelheim Investigational Site Mülheim Germany
    113 Boehringer Ingelheim Investigational Site München Germany
    114 Boehringer Ingelheim Investigational Site Neu-Ulm Germany
    115 Boehringer Ingelheim Investigational Site Neunkirchen Germany
    116 Boehringer Ingelheim Investigational Site Norderstedt Germany
    117 Boehringer Ingelheim Investigational Site Nordhausen Germany
    118 Boehringer Ingelheim Investigational Site Nürnberg Germany
    119 Boehringer Ingelheim Investigational Site Oberursel Germany
    120 Boehringer Ingelheim Investigational Site Olpe Germany
    121 Boehringer Ingelheim Investigational Site Oschersleben Germany
    122 Boehringer Ingelheim Investigational Site Osnabrück Germany
    123 Boehringer Ingelheim Investigational Site Papenburg Germany
    124 Boehringer Ingelheim Investigational Site Peine Germany
    125 Boehringer Ingelheim Investigational Site Plauen Germany
    126 Boehringer Ingelheim Investigational Site Potsdam Germany
    127 Boehringer Ingelheim Investigational Site Pulheim Germany
    128 Boehringer Ingelheim Investigational Site Rastatt Germany
    129 Boehringer Ingelheim Investigational Site Rathenow Germany
    130 Boehringer Ingelheim Investigational Site Regensburg Germany
    131 Boehringer Ingelheim Investigational Site Remscheid Germany
    132 Boehringer Ingelheim Investigational Site Rendsburg Germany
    133 Boehringer Ingelheim Investigational Site Rostock Germany
    134 Boehringer Ingelheim Investigational Site Rüdersdorf Germany
    135 Boehringer Ingelheim Investigational Site Rüsselsheim Germany
    136 Boehringer Ingelheim Investigational Site Saarbrücken Germany
    137 Boehringer Ingelheim Investigational Site Saarlouis Germany
    138 Boehringer Ingelheim Investigational Site Salzgitter Germany
    139 Boehringer Ingelheim Investigational Site Schenefeld Germany
    140 Boehringer Ingelheim Investigational Site Schleswig Germany
    141 Boehringer Ingelheim Investigational Site Schmölln Germany
    142 Boehringer Ingelheim Investigational Site Schwalmstadt Germany
    143 Boehringer Ingelheim Investigational Site Schwalmtal Germany
    144 Boehringer Ingelheim Investigational Site Schwerin Germany
    145 Boehringer Ingelheim Investigational Site Sebnitz Germany
    146 Boehringer Ingelheim Investigational Site Seevetal Germany
    147 Boehringer Ingelheim Investigational Site Siegen Germany
    148 Boehringer Ingelheim Investigational Site Singen Germany
    149 Boehringer Ingelheim Investigational Site Sinsheim Germany
    150 Boehringer Ingelheim Investigational Site Solingen Germany
    151 Boehringer Ingelheim Investigational Site Sonneberg Germany
    152 Boehringer Ingelheim Investigational Site Spremberg Germany
    153 Boehringer Ingelheim Investigational Site Stade Germany
    154 Boehringer Ingelheim Investigational Site Starnberg Germany
    155 Boehringer Ingelheim Investigational Site Steinbach Germany
    156 Boehringer Ingelheim Investigational Site Straelen Germany
    157 Boehringer Ingelheim Investigational Site Strausberg Germany
    158 Boehringer Ingelheim Investigational Site Stuttgart Germany
    159 Boehringer Ingelheim Investigational Site Teltow Germany
    160 Boehringer Ingelheim Investigational Site Teterow Germany
    161 Boehringer Ingelheim Investigational Site Troisdorf Germany
    162 Boehringer Ingelheim Investigational Site Unna Germany
    163 Boehringer Ingelheim Investigational Site Uttenreuth Germany
    164 Boehringer Ingelheim Investigational Site Verden Germany
    165 Boehringer Ingelheim Investigational Site Waiblingen Germany
    166 Boehringer Ingelheim Investigational Site Warendorf Germany
    167 Boehringer Ingelheim Investigational Site Waren Germany
    168 Boehringer Ingelheim Investigational Site Weiden Germany
    169 Boehringer Ingelheim Investigational Site Weißenhorn Germany
    170 Boehringer Ingelheim Investigational Site Wetzlar Germany
    171 Boehringer Ingelheim Investigational Site Wiesloch Germany
    172 Boehringer Ingelheim Investigational Site Wilhelmshaven Germany
    173 Boehringer Ingelheim Investigational Site Witten Germany
    174 Boehringer Ingelheim Investigational Site Worms Germany
    175 Boehringer Ingelheim Investigational Site Wuppertal Germany
    176 Boehringer Ingelheim Investigational Site Zella-Mehlis Germany
    177 Boehringer Ingelheim Investigational Site Zossen Germany

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00540163
    Other Study ID Numbers:
    • 205.402
    First Posted:
    Oct 5, 2007
    Last Update Posted:
    Nov 28, 2013
    Last Verified:
    Oct 1, 2013
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Dyspnea

    Study Results

    No Results Posted as of Nov 28, 2013