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DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT02552160
Collaborator
(none)
3,732
Enrollment
180
Locations
27.2
Actual Duration (Months)
20.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    3732 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Non-interventional Study for Documentation of the Therapeutic Efficacy, Use and Tolerance of the Fixed-Dose Combinations (FDC) Duaklir® Genuair® (Aclidinium/Formoterol), Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) and Anoro® (Umeclidinium/Vilanterol) in the Treatment of COPD Under Real Conditions in the Practices of Pneumologists, Internists, and General Practitioners
    Actual Study Start Date :
    Sep 24, 2015
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    Dec 31, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Patients on Duaklir® Genuair®

    Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)
    Patients on Ultibro® Breezhaler®

    Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)
    Patients on Anoro®

    Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)

    Outcome Measures

    Primary Outcome Measures

    1. Lung function [First visit (baseline)]

      Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)

    2. Number of patients with concomitant diseases classified by diagnostic subgroups [First visit (baseline)]

    3. Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups [First visit (baseline)]

    4. Number of patients with exacerbations within the previous 24 months [First visit (baseline)]

      History of previous exacerbations that will be collected at first observational visit.

    Secondary Outcome Measures

    1. Change in well-being and quality of life [First visit (baseline) to end of observational period at 12 months]

      CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months.

    2. Effect on the severity of the shortness of breath [First visit (baseline) to end of observational period at 12 months]

      mMRC (modified Medical Research Council Dyspnea Scale) questionnaire will be completed at each visit, approximately every 3 months.

    3. Change in the night-time and early-morning COPD symptoms [First visit (baseline) to end of observational period at 12 months]

      NiSCI/EMSCI (Night-time symptoms of COPD Instrument / Early-morning symptoms of COPD instrument) questionnaire will be completed at each visit, approximately every 3 months.

    4. Lung function [First visit (baseline) to end of observational period at 12 months]

      Assessment of FEV1, FVC at each visit, approximately every 3 months.

    5. Number of exacerbations by grade [First visit (baseline) to end of observational period at 12 months]

      Number of exacerbations will be collected at each visit, approximately every 3 months

    6. Adverse events [First visit (baseline) to end of observational period at 12 months]

      Adverse events will be collected at each visit, approximately every 3 months.

    7. Handling of inhaler [At 12 months]

      Questionnaire regarding handling of inhaler by patient

    Eligibility Criteria

    Criteria

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

    • Female/male of at least 40 years of age

    • Patient diagnosed with COPD

    • Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol).

    • Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended).

    • Signed declaration of consent

    Exclusion Criteria:

    • The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient.

    • Patient is pregnant, plans to become pregnant, or is nursing during the therapy period.

    • Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations.

    • Patient is participating in a clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aachen D6570r00001 Germany D6570R00001
    2 Research Site Aldenhofen D6570r00001 Germany D6570R00001
    3 Research Site Aldenhoven D6570r00001 Germany D6570R00001
    4 Research Site Alzey D6570r00001 Germany D6570R00001
    5 Research Site Ansbach D6570r00001 Germany D6570R00001
    6 Research Site Apolda D6570r00001 Germany D6570R00001
    7 Research Site Aschau D6570r00001 Germany D6570R00001
    8 Research Site Auerbach D6570r00001 Germany D6570R00001
    9 Research Site Augsburg D6570r00001 Germany D6570R00001
    10 Research Site Bad Fallingbostel D6570r00001 Germany D6570R00001
    11 Research Site Bad Hersfeld D6570r00001 Germany D6570R00001
    12 Research Site Bad Honnef D6570r00001 Germany D6570R00001
    13 Research Site Bad Lippspringe D6570r00001 Germany D6570R00001
    14 Research Site Bad Reichenhall D6570r00001 Germany D6570R00001
    15 Research Site Bad Sachsa D6570r00001 Germany D6570R00001
    16 Research Site Bad Windsheim D6570r00001 Germany D6570R00001
    17 Research Site Bad Woerishofen D6570r00001 Germany D6570R00001
    18 Research Site Bamberg D6570r00001 Germany D6570R00001
    19 Research Site Beelitz-Heilstaetten D6570r00001 Germany D6570R00001
    20 Research Site Bergisch Gladbach D6570r00001 Germany D6570R00001
    21 Research Site Berlin D6570r00001 Germany D6570R00001
    22 Research Site Biberach D6570r00001 Germany D6570R00001
    23 Research Site Birkenwerder D6570r00001 Germany D6570R00001
    24 Research Site Bitterfeld-Wolfen D6570r00001 Germany D6570R00001
    25 Research Site Bochum D6570r00001 Germany D6570R00001
    26 Research Site Boehlen D6570r00001 Germany D6570R00001
    27 Research Site Bonn D6570r00001 Germany D6570R00001
    28 Research Site Bottrop D6570r00001 Germany D6570R00001
    29 Research Site Braunschweig D6570r00001 Germany D6570R00001
    30 Research Site Bruchsal D6570r00001 Germany D6570R00001
    31 Research Site Buechen D6570r00001 Germany D6570R00001
    32 Research Site Burghaslach D6570r00001 Germany D6570R00001
    33 Research Site Burgwedel D6570r00001 Germany D6570R00001
    34 Research Site Celle D6570r00001 Germany D6570R00001
    35 Research Site Chemnitz D6570r00001 Germany D6570R00001
    36 Research Site Cottbus D6570r00001 Germany D6570R00001
    37 Research Site Darmstadt D6570r00001 Germany D6570R00001
    38 Research Site Delitzsch D6570r00001 Germany D6570R00001
    39 Research Site Dessau D6570r00001 Germany D6570R00001
    40 Research Site Dorsten D6570r00001 Germany D6570R00001
    41 Research Site Dortmund D6570r00001 Germany D6570R00001
    42 Research Site Dresden D6570r00001 Germany D6570R00001
    43 Research Site Dueren D6570r00001 Germany D6570R00001
    44 Research Site Duesseldorf D6570r00001 Germany D6570R00001
    45 Research Site Duisburg D6570r00001 Germany D6570R00001
    46 Research Site Eimsheim D6570r00001 Germany D6570R00001
    47 Research Site Ellerstadt D6570r00001 Germany D6570R00001
    48 Research Site Elsterwerda D6570r00001 Germany D6570R00001
    49 Research Site Elterlein D6570r00001 Germany D6570R00001
    50 Research Site Essen D6570r00001 Germany D6570R00001
    51 Research Site Euerbach-Obbach D6570r00001 Germany D6570R00001
    52 Research Site Euskirchen D6570r00001 Germany D6570R00001
    53 Research Site Flensburg D6570r00001 Germany D6570R00001
    54 Research Site Frankfurt/M. D6570r00001 Germany D6570R00001
    55 Research Site Frankfurt D6570r00001 Germany D6570R00001
    56 Research Site Freiberg D6570r00001 Germany D6570R00001
    57 Research Site Fuerstenwalde D6570r00001 Germany D6570R00001
    58 Research Site Fuerth D6570r00001 Germany D6570R00001
    59 Research Site Ganderkesee D6570r00001 Germany D6570R00001
    60 Research Site Garching D6570r00001 Germany D6570R00001
    61 Research Site Garmisch-Partenkirchen D6570r00001 Germany D6570R00001
    62 Research Site Gauting D6570r00001 Germany D6570R00001
    63 Research Site Gera D6570r00001 Germany D6570R00001
    64 Research Site Gerwisch D6570r00001 Germany D6570R00001
    65 Research Site Glienicke D6570r00001 Germany D6570R00001
    66 Research Site Greiz D6570r00001 Germany D6570R00001
    67 Research Site Guetersloh D6570r00001 Germany D6570R00001
    68 Research Site Hagen D6570r00001 Germany D6570R00001
    69 Research Site Halberstadt D6570r00001 Germany D6570R00001
    70 Research Site Halle D6570r00001 Germany D6570R00001
    71 Research Site Hamburg D6570r00001 Germany D6570R00001
    72 Research Site Hannover D6570r00001 Germany D6570R00001
    73 Research Site Hartenstein D6570r00001 Germany D6570R00001
    74 Research Site Heidelberg D6570r00001 Germany D6570R00001
    75 Research Site Hemmingen D6570r00001 Germany D6570R00001
    76 Research Site Hettstedt D6570r00001 Germany D6570R00001
    77 Research Site Hoechstadt D6570r00001 Germany D6570R00001
    78 Research Site Hoyerswerda D6570r00001 Germany D6570R00001
    79 Research Site Ibbenbueren D6570r00001 Germany D6570R00001
    80 Research Site Ingolstadt D6570r00001 Germany D6570R00001
    81 Research Site Iserlohn D6570r00001 Germany D6570R00001
    82 Research Site Issum D6570r00001 Germany D6570R00001
    83 Research Site Jena D6570r00001 Germany D6570R00001
    84 Research Site Karlsruhe D6570r00001 Germany D6570R00001
    85 Research Site Kevelaer D6570r00001 Germany D6570R00001
    86 Research Site Kleve D6570r00001 Germany D6570R00001
    87 Research Site Koeln-Hoehenberg D6570r00001 Germany D6570R00001
    88 Research Site Koeln-Rodenkirchen D6570r00001 Germany D6570R00001
    89 Research Site Koeln D6570r00001 Germany D6570R00001
    90 Research Site Koethen D6570r00001 Germany D6570R00001
    91 Research Site Kolbermoor D6570r00001 Germany D6570R00001
    92 Research Site Krefeld D6570r00001 Germany D6570R00001
    93 Research Site Kronach D6570r00001 Germany D6570R00001
    94 Research Site Kyritz D6570r00001 Germany D6570R00001
    95 Research Site Langenfeld D6570r00001 Germany D6570R00001
    96 Research Site Leer D6570r00001 Germany D6570R00001
    97 Research Site Leipzig D6570r00001 Germany D6570R00001
    98 Research Site Leonberg D6570r00001 Germany D6570R00001
    99 Research Site Lippstadt D6570r00001 Germany D6570R00001
    100 Research Site Ludwigsburg-Ossweil D6570r00001 Germany D6570R00001
    101 Research Site Ludwigshafen D6570r00001 Germany D6570R00001
    102 Research Site Luebeck D6570r00001 Germany D6570R00001
    103 Research Site Magdeburg D6570r00001 Germany D6570R00001
    104 Research Site Mainz D6570r00001 Germany D6570R00001
    105 Research Site Mannheim D6570r00001 Germany D6570R00001
    106 Research Site Marburg D6570r00001 Germany D6570R00001
    107 Research Site Markt Bibart D6570r00001 Germany D6570R00001
    108 Research Site Menden D6570r00001 Germany D6570R00001
    109 Research Site Merzig D6570r00001 Germany D6570R00001
    110 Research Site Moenchengladbach D6570r00001 Germany D6570R00001
    111 Research Site Moers D6570r00001 Germany D6570R00001
    112 Research Site Monheim D6570r00001 Germany D6570R00001
    113 Research Site Mosbach D6570r00001 Germany D6570R00001
    114 Research Site Muehlhausen D6570r00001 Germany D6570R00001
    115 Research Site Muenchen D6570r00001 Germany D6570R00001
    116 Research Site Neumarkt D6570r00001 Germany D6570R00001
    117 Research Site Neunkirchen D6570r00001 Germany D6570R00001
    118 Research Site Neuruppin D6570r00001 Germany D6570R00001
    119 Research Site Neusaess D6570r00001 Germany D6570R00001
    120 Research Site Neustadt/Aisch D6570r00001 Germany D6570R00001
    121 Research Site Neuwied D6570r00001 Germany D6570R00001
    122 Research Site Nuernberg D6570r00001 Germany D6570R00001
    123 Research Site Oettingen D6570r00001 Germany D6570R00001
    124 Research Site Oschatz D6570r00001 Germany D6570R00001
    125 Research Site Oy-Mittelberg D6570r00001 Germany D6570R00001
    126 Research Site Pirmasens D6570r00001 Germany D6570R00001
    127 Research Site Potsdam D6570r00001 Germany D6570R00001
    128 Research Site Pulheim-Braunweiler D6570r00001 Germany D6570R00001
    129 Research Site Radebeul D6570r00001 Germany D6570R00001
    130 Research Site Rastatt D6570r00001 Germany D6570R00001
    131 Research Site Rathenow D6570r00001 Germany D6570R00001
    132 Research Site Recklinghausen D6570r00001 Germany D6570R00001
    133 Research Site Remscheid D6570r00001 Germany D6570R00001
    134 Research Site Reutlingen D6570r00001 Germany D6570R00001
    135 Research Site Rosenheim D6570r00001 Germany D6570R00001
    136 Research Site Rostock D6570r00001 Germany D6570R00001
    137 Research Site Roth D6570r00001 Germany D6570R00001
    138 Research Site Ruedersdorf D6570r00001 Germany D6570R00001
    139 Research Site Ruesselsheim D6570r00001 Germany D6570R00001
    140 Research Site Rust D6570r00001 Germany D6570R00001
    141 Research Site Saalfeld D6570r00001 Germany D6570R00001
    142 Research Site Saarbruecken D6570r00001 Germany D6570R00001
    143 Research Site Saarlouis D6570r00001 Germany D6570R00001
    144 Research Site Schleswig D6570r00001 Germany D6570R00001
    145 Research Site Schmoelln D6570r00001 Germany D6570R00001
    146 Research Site Schoenbrunn D6570r00001 Germany D6570R00001
    147 Research Site Schwedt D6570r00001 Germany D6570R00001
    148 Research Site Siegen D6570r00001 Germany D6570R00001
    149 Research Site Simmern D6570r00001 Germany D6570R00001
    150 Research Site Solingen D6570r00001 Germany D6570R00001
    151 Research Site Sonsbeck D6570r00001 Germany D6570R00001
    152 Research Site Spiesen D6570r00001 Germany D6570R00001
    153 Research Site Spremberg D6570r00001 Germany D6570R00001
    154 Research Site Steinhagen D6570r00001 Germany D6570R00001
    155 Research Site Strasskirchen D6570r00001 Germany D6570R00001
    156 Research Site Strausberg D6570r00001 Germany D6570R00001
    157 Research Site Stuttgart D6570r00001 Germany D6570R00001
    158 Research Site Sulzberg D6570r00001 Germany D6570R00001
    159 Research Site Teterow D6570r00001 Germany D6570R00001
    160 Research Site Teuchern D6570r00001 Germany D6570R00001
    161 Research Site Thaleischweiler-Froeschen D6570r00001 Germany D6570R00001
    162 Research Site Trier D6570r00001 Germany D6570R00001
    163 Research Site Ulm D6570r00001 Germany D6570R00001
    164 Research Site Unterwellenborn D6570r00001 Germany D6570R00001
    165 Research Site Ursensollen D6570r00001 Germany D6570R00001
    166 Research Site Voerde D6570r00001 Germany D6570R00001
    167 Research Site Wallenhorst D6570r00001 Germany D6570R00001
    168 Research Site Wardenburg D6570r00001 Germany D6570R00001
    169 Research Site Warendorf D6570r00001 Germany D6570R00001
    170 Research Site Waren D6570r00001 Germany D6570R00001
    171 Research Site Wehrheim D6570r00001 Germany D6570R00001
    172 Research Site Weilheim D6570r00001 Germany D6570R00001
    173 Research Site Weissenburg D6570r00001 Germany D6570R00001
    174 Research Site Weisswasser D6570r00001 Germany D6570R00001
    175 Research Site Wiesbaden D6570r00001 Germany D6570R00001
    176 Research Site Wittenberg D6570r00001 Germany D6570R00001
    177 Research Site Witten D6570r00001 Germany D6570R00001
    178 Research Site Worms D6570r00001 Germany D6570R00001
    179 Research Site Wuppertal D6570r00001 Germany D6570R00001
    180 Research Site Zwoenitz D6570r00001 Germany D6570R00001

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT02552160
    Other Study ID Numbers:
    • D6570R00001
    First Posted:
    Sep 17, 2015
    Last Update Posted:
    Dec 11, 2018
    Last Verified:
    Dec 1, 2018
    Keywords provided by AstraZeneca
    Chronic Obstructive Pulmonary Disease
    Fixed-dose Combination
    LAMA/LABA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists)
    Inhaler
    Aclidinium/Formoterol
    Glycopyrronium/Indacaterol
    Umeclidinium/Vilanterol
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Dec 11, 2018