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Study Protocols ABCD TITLE PAGE Protocol for observational studies based on existing data Document Number: c02329987-02 BI Study Number: 1222.53 BI Investigational Olodaterol Product(s): Title: Drug Utilisation Study for Olodaterol Protocol version Version 2.0 identifier: Date of last version of 13 Feb 2014 protocol: PASS: Yes EU PASS register Study not registered number: Active substance: Olodaterol Medicinal product: Striverdi, Respimat Product reference: BI 1744 Procedure number: Not applicable Marketing authorisation Boehringer Ingelheim GmbH holder(s): Joint PASS: No Date: 14 Oct 2014 Page 1 of 65 Proprietary confidential information © 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission Boehringer Ingelheim Page 2 of 65 Protocol for observational studies based on existing data BI Study Number 1222.53 c02329987-02 Proprietary confidential information © 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies Additional Information Research question and This study aims to characterise the use of single-agent olodaterol objectives: and single-agent indacaterol, the only marketed long-acting beta2-agonist (LABAs) authorised for chronic obstructive pulmonary disease (COPD), but not for asthma, in clinical practice. Study objectives are as follows: Primary objectives: Quantify the frequency of off-label use of olodaterol among new users of these medications (i.e., the proportion of new users who do not have COPD) Describe the baseline characteristics of new users of olodaterol Secondary objective: Quantify the frequency of off-label use of indacaterol (a LABA approved for COPD but not for asthma) among new users of these medications (i.e., the proportion of new users who do not have COPD), in order to put into perspective the results for olodaterol initiators Describe the baseline characteristics of new users of indacaterol Country(-ies) of study: The Netherlands, Denmark, and Sweden Author: Marketing authorisation holder(s): MAH contact person: EU-QPPV: Signature of EU-QPPV: The signature of the EU-QPPV is provided electronically Boehringer Ingelheim Page 3 of 65 Protocol for observational studies based on existing data BI Study Number 1222.53 c02329987-02 Proprietary confidential information © 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 1. TABLE OF CONTENTS TITLE PAGE .................................................................................................................. 1 1. TABLE OF CONTENTS....................................................................................... 3 2. LIST OF ABBREVIATIONS................................................................................ 6 3. RESPONSIBLE PARTIES.................................................................................... 8 4. ABSTRACT........................................................................................................... 9 5. AMENDMENTS AND UPDATES..................................................................... 11 6. MILESTONES..................................................................................................... 12 7. RATIONALE AND BACKGROUND................................................................ 13 8. RESEARCH QUESTION AND OBJECTIVES ................................................. 14 9. RESEARCH METHODS .................................................................................... 15 9.1 STUDY DESIGN............................................................................................ 15 9.2 SETTING ........................................................................................................ 15 9.2.1 Source population.................................................................................... 18 9.2.2 Study period ............................................................................................ 18 9.2.3 Study groups............................................................................................ 18 9.2.3.1 Inclusion criteria ..................................................................................19 9.2.3.2 Exclusion criteria .................................................................................19 9.3 VARIABLES .................................................................................................. 19 9.3.1 Exposures ................................................................................................ 19 9.3.2 Indication and potential off-label prescribing ......................................... 19 9.3.2.1 On-label prescribing: indication of COPD ..........................................20 9.3.2.2 Off-label prescribing............................................................................21 9.3.2.3 Review of patient profiles and medical records...................................22 9.3.2.4 Classification of patients......................................................................22 9.3.3 Characterisation of new users of olodaterol and indacaterol .................. 23 9.3.3.1 Demographics and lifestyle habits at the index date............................23 9.3.3.2 Respiratory comorbidity and allergies.................................................23 9.3.3.3 Severity of COPD ................................................................................24 9.3.3.4 Definition of COPD severity ...............................................................26 9.3.3.5 Other comorbidity and conditions .......................................................27 9.3.3.6 Comedications......................................................................................28 9.3.3.7 Health care resource utilisation............................................................28 9.3.4 Outcomes................................................................................................. 28 Boehringer Ingelheim Page 4 of 65 Protocol for observational studies based on existing data BI Study Number 1222.53 c02329987-02 Proprietary confidential information © 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 9.3.4.1 Primary outcome..................................................................................28 9.3.4.2 Secondary outcomes ............................................................................29 9.3.4.3 The secondary outcome is the prevalence of off-label prescribing among new users of indacaterol.......................................................................................29 9.3.5 Covariates................................................................................................ 29 9.4 DATA SOURCES........................................................................................... 29 9.4.1 PHARMO Database Network ................................................................. 29 9.4.1.1 Database characteristics.......................................................................29 9.4.2 Denmark .................................................................................................. 30 9.4.3 Sweden .................................................................................................... 30 9.4.4 Summary of study databases ................................................................... 31 9.5 STUDY SIZE.................................................................................................. 34 9.6 DATA MANAGEMENT................................................................................ 35 9.7 DATA ANALYSIS......................................................................................... 36 9.7.1 Main analysis........................................................................................... 36 9.7.2 Indication and potential off-label prescribing ......................................... 36 9.7.3 Number of users and patterns of use ....................................................... 36 9.7.4 Characterisation of new users at the index date ...................................... 36 9.8 QUALITY CONTROL................................................................................... 38 9.9 LIMITATIONS OF THE RESEARCH METHODS...................................... 38 9.10 OTHER ASPECTS ......................................................................................... 39 9.10.1 Bias.......................................................................................................... 39 10. PROTECTION OF HUMAN SUBJECTS .......................................................... 40 11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS....................................................................................................... 41 12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS ............................................................................................................................. 42 13. REFERENCES .................................................................................................... 43 13.1 PUBLISHED REFERENCES......................................................................... 43 13.2 UNPUBLISHED REFERENCES................................................................... 47 ANNEX 1. LIST OF STAND-ALONE DOCUMENTS........................................... 48 ANNEX 2. ENCEPP CHECKLIST FOR STUDY PROTOCOLS ........................... 49 ANNEX
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