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NCT01990534	6.2.5	Criteria for Discontinuation of Brentuximab Vedotin	Criteria for discontinuation of the study drug are provided in Section [7.7.](#page-50-0) Please refer to Table 6-1 for further information regarding dose requirements for patients who discontinue the study drug due to toxicity. Patients will attend the EOT visit 30 days (± 7 days) after receiving their last dose of t...	[]
NCT01990534	6.3	Excluded Concomitant Medications and Procedures	The following medications and procedures are prohibited during the study: - Chemotherapy. - Immunotherapy. - No other investigational drug may be used during the treatment period of this study. - Concurrent participation in another clinical study with medical intervention.	[]
NCT01990534	6.4	Permitted Concomitant Medications and Procedures	The following medications and procedures are allowed during the study: - The use of topical, inhalational, and ophthalmic steroids is permitted. Corticosteroids are permitted as part of a premedication regimen or for the treatment of HL-related symptoms, according to institutional standards or to manage potential hyp...	[]
NCT01990534	6.5	Precautions and Restrictions	MMAE is primarily metabolized by CYP3A. Patients who are receiving strong CYP3A inhibitors concomitantly with brentuximab vedotin should be closely monitored for adverse reactions. Please refer to the Study Manual for a list of examples of strong CYP3A inhibitors. An IRR may occur during the infusion of brentuximab...	[ "Use of CYP3A Inhibitors", "Infusion-related Reactions", "Pregnancy" ]
NCT01990534	6.6	Management of Clinical Events	Although this study will not initially employ prophylactic antiemetics, their use is not prohibited in the management of a patient who develops nausea and/or vomiting. As in the prophylactic setting, 5-hydroxytryptamine 3 (5-HT3) serotonin receptor antagonists and corticosteroids should be used for treatment first in...	[ "Nausea and/or Vomiting", "Diarrhea", "Peripheral Neuropathy", "Suspected Progressive Multifocal Leukoencephalopathy", "Anaphylaxis" ]
NCT01990534	6.7	Blinding and Unblinding	Blinding is not applicable in this single-arm study.	[]
NCT01990534	6.8	Description of Investigational Agents	Brentuximab vedotin for Injection is a sterile, preservative-free, white to off white lyophilized cake for reconstitution for IV administration. Brentuximab vedotin for Injection is supplied in single-use, Type 1 borosilicate glass vials with FluroTec® -coated butyl rubber stoppers and aluminum seals. Each vial of the ...	[]
NCT01990534	6.9	Preparation, Reconstitution, and Dispensation of Brentuximab Vedotin	Brentuximab vedotin is an anticancer drug, and as with other potentially toxic compounds, caution should be exercised when handling brentuximab vedotin. Recommended safety measures for handling and preparation include masks, protective clothing, gloves, and vertical laminar airflow safety cabinets. Study treatment via...	[]
NCT01990534	6.10	Packaging and Labeling	Brentuximab vials will be packaged as single-use cartons. Each carton will contain 1 vial of the investigational product and the vial and carton will be labeled to meet country-specific regulatory requirements.	[]
NCT01990534	6.11	Storage, Handling, and Accountability	Brentuximab vedotin must be refrigerated at 2C to 8C in a secure location (eg, locked room) that is accessible to the pharmacist, the investigator, or a duly designated person only. Brentuximab vedotin does not contain preservatives; therefore, opened and reconstituted vials of brentuximab vedotin must be used within ...	[]
NCT01990534	7	STUDY CONDUCT	This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), applicable regulatory requirements, and International Conference on Harmonisation (ICH) guidelines.	[]
NCT01990534	7.1	Study Personnel and Organizations	The contact information for the Millennium project clinician for this study, the central laboratory and any additional clinical laboratories, the coordinating investigator for each member state/country, the IRF, the IXRS (IVRS/IWRS) provider, and the contract research organization (CRO) team may be found in the Study M...	[]
NCT01990534	7.2	Arrangements for Recruitment of Patients	Recruitment and enrollment strategies for this study may include recruitment from the investigator's local practice or referrals from other physicians. If advertisements become part of the recruitment strategy, they will be reviewed by the institutional review board (IRB)/independent ethics committee (IEC). It is not ...	[]
NCT01990534	7.3	Treatment Group Assignments	This is a single-arm study with no reference therapy. Treatment group assignments are not applicable. An IXRS (IVRS/IWRS) system will be used to enroll patients in this study.	[]
NCT01990534	7.4	Study Procedures	Refer to the [Schedule of Events](#page-6-0) for timing of assessments. Additional details are provided as necessary in the sections that follow.	[]
NCT01990534	7.4.1	Informed Consent	Each patient must provide written informed consent before any study-required procedures are conducted, unless those procedures are performed as part of the patient's standard care.	[]
NCT01990534	7.4.2	Patient Demographics	The date of birth, race, ethnicity, and sex of the patient are to be recorded during screening, according to country and local regulations.	[]
NCT01990534	7.4.3	Medical History	During the Screening period, a complete medical history will be compiled for each patient. The history will emphasize the background and progress of the patient's malignancy and include a description of prior therapies for it. In addition, concomitant medications will be recorded as specified in Section [7.4.12.](#page...	[]
NCT01990534	7.4.4	Physical Examination	A physical examination will be completed per standard of care at the times specified in the Schedule of Events. Physical examination will include a focused lymphoma assessment and an evaluation of skin, head, eyes, ears, nose, throat, nodes, heart, lungs, abdomen, back, extremities, and neurology. Property of [Taked](#...	[]
NCT01990534	7.4.5	Patient Height	Height will be measured only during screening (within 28 days before the first dose of brentuximab vedotin).	[]
NCT01990534	7.4.6	Patient Weight	Weight will be measured at times specified in the [Schedule of Events.](#page-6-0) The actual dose of brentuximab vedotin is determined on the basis of the patients' weight, according to institutional guidelines; however, doses will be adjusted for patients who experience a 10% change from baseline in body weight (Sect...	[]
NCT01990534	7.4.7	Vital Signs	Vital signs measurements will be assessed at times specified in the [Schedule of Events](#page-6-0) and include seated (after 3 to 5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.	[]
NCT01990534	7.4.8	Pregnancy Test	A serum or urine pregnancy test will be performed for female patients of childbearing potential at times specified in the [Schedule of Events.](#page-6-0)	[]
NCT01990534	7.4.9	Eastern Cooperative Oncology Group Performance Status	ECOG performance status score will be assessed at times specified in the [Schedule of](#page-6-0) [Events.](#page-6-0) See Section [15.2](#page-74-0) for a description of the ECOG scale for performance status.	[]
NCT01990534	7.4.10	Tumor Specimen Measurements	If available, tumor tissue collected from the time of the most recent diagnostic biopsy of the original diagnosis or subsequent procedures for relapsed or refractory disease (unstained slides or a paraffin embedded block) will be obtained after the patient has signed the informed consent form (ICF). Patients who have a...	[]
NCT01990534	7.4.11	Electrocardiograms	A 12-lead electrocardiogram (ECG) will be administered at the time of screening, as specified in the [Schedule of Events.](#page-6-0) Clinical Study Protocol C25007, EudraCT: 2013-00232-10	[]
NCT01990534	7.4.12	Concomitant Medications and Procedures	Medications used by the patient and therapeutic procedures that the patient completes will be recorded in the eCRF as specified in the [Schedule of Events.](#page-6-0) Refer to Section [6.3](#page-39-0) for a list of excluded concomitant medications procedures and Section [6.4](#page-39-0) for a list of permitted conco...	[]
NCT01990534	7.4.13	Adverse Events	Monitoring of AEs, serious and nonserious, will be conducted throughout the study as specified in the [Schedule of Events.](#page-6-0) Refer to Section [10](#page-59-0) for details regarding definitions, documentation, and reporting of pretreatment events, AEs, and SAEs.	[]
NCT01990534	7.4.14	Enrollment	A patient is considered to be enrolled in the study when he or she is enrolled in the IXRS (IVRS/IWRS). Procedures for completion of the enrollment information are described in the Study Manual.	[]
NCT01990534	7.4.15	Clinical Laboratory Evaluations	Clinical laboratory evaluations will be performed centrally. Decisions regarding eligibility and administration of the study drug may be made by using local laboratory results. If local clinical laboratory values are used for either eligibility or study dose administration decisions, samples for central laboratory conf...	[ "Clinical Chemistry and Hematology", "Hematology", "Brentuximab Vedotin (ADCETRIS® )", "Serum Chemistry" ]
NCT01990534	7.4.16	Disease Assessment	Response to treatment and disease status assessments will be evaluated according to the IWG criteria for patients with lymphoma. ([1\)](#page-70-0) Disease assessments will be performed as specified in the [Schedule of Events.](#page-6-0) Records of disease assessments will be provided to the IRF for central review. A...	[]
NCT01990534	7.4.17	Pharmacokinetic Measurements	PK measurements will be taken for MMAE, ADC, and total antibody. PK values to be estimated may include the maximum plasma concentration (Cmax) for MMAE, and concentration at the end of infusion (Ceoi) for brentuximab vedotin. Population PK methodologies may be used to determine PK parameters and covariates in this popu...	[]
NCT01990534	7.4.18	Serum Biomarkers	![](_page_49_Picture_6.jpeg)	[]
NCT01990534	7.4.19	Immunogenicity	Blood for serum samples will be collected as specified in the [Schedule of Events](#page-6-0) to evaluate ATAs and neutralizing ATAs as a safety assessment. On the days of dose administration, the blood samples for ATA and neutralizing ATA assessment must be collected before the dose is administered. Neutralizing ATA a...	[]
NCT01990534	7.4.21	Cost Assessment	The cost of treatment will be assessed through the collection of health care utilization data. Valuation of the costs will be undertaken separately.	[]
NCT01990534	7.5	Completion of Treatment	Patients will be considered to have completed study treatment if they complete 16 cycles of brentuximab vedotin.	[]
NCT01990534	7.6	Completion of Study	Patients will be considered to have completed the study if they complete 16 cycles of treatment with brentuximab vedotin and complete the EOT visit. Regardless of the duration of treatment, all patients will remain on study for follow-up after receiving the last dose of study treatment until they withdraw consent for ...	[]
NCT01990534	7.7	Discontinuation of Treatment With Study Drug, and Patient Replacement	Study drug must be permanently discontinued for patients meeting any of the following criteria: Completed the maximum number of cycles of brentuximab vedotin, as described in the protocol Progressive disease - Initiation of hematopoietic stem cell transplantation - Withdrawal of informed consent by the subject. Th...	[]
NCT01990534	7.8	Withdrawal of Patients From Study	A patient may be withdrawn from the study for any of the following reasons: - Lost to follow-up - Study terminated by sponsor - Withdrawal by subject - Death - Other The consequence of study withdrawal is that no new information will be collected from the withdrawn patient and added to the existing data or any datab...	[]
NCT01990534	7.9	Study Compliance	Study drug will be administered or dispensed only to eligible patients under the supervision of the investigator or identified subinvestigator(s). The appropriate study personnel will maintain records of study drug receipt and dispensing.	[]
NCT01990534	7.10	Posttreatment Follow-up Assessments (Progression-Free Survival and Overall Survival)	Posttreatment follow-up for all patients consists of a physical examination, CT scan, collection of OS/PFS status, and anticancer treatment for HL as specified in the [Schedule of](#page-6-0) Events. Patients who discontinue study treatment with a CR, a PR, or stable disease will have CT scans done every 3 months for...	[]
NCT01990534	8	STATISTICAL AND QUANTITATIVE ANALYSES		[]
NCT01990534	8.1	Statistical Methods	Statistical analyses will be primarily descriptive and graphical. For continuous variables, descriptive statistics will be used including number (n), mean, median, standard deviation, minimum, and maximum. For categorical variables, frequencies and percentages will be used for the analyses. The Kaplan-Meier survival cu...	[]
NCT01990534	8.1.1	Determination of Sample Size	At least 60 patients with relapsed or refractory classical HL who are considered to be not suitable for SCT or multiagent chemotherapy will be enrolled in this study. With a sample size of 60 patients and different ORRs, the two-sided 95% CIs will vary. An example is shown (Table 8-1). Clinical Study Protocol C25007, ...	[]
NCT01990534	8.1.2	Randomization and Stratification		[]
NCT01990534	8.1.3	Populations for Analysis	Additional details of analyses and analysis sets of patients may be defined in the SAP. ![](_page_54_Picture_15.jpeg)	[]
NCT01990534	8.1.4	Procedures for Handling Missing, Unused, and Spurious Data	All available efficacy and safety data will be included in data listings and tabulations. The relevance of missing sample data will be assessed. Details on any sensitivity analyses and data handling details regarding issues such as missing data will be discussed in the SAP. Data that are potentially spurious or errone...	[]
NCT01990534	8.1.5	Demographic and Baseline Characteristics	Demographics, baseline characteristics, and prior medications will be summarized. Selected listings will also be provided.	[]
NCT01990534	8.1.6	Efficacy Analysis	The primary and secondary efficacy endpoints will be summarized. The corresponding two-sided 95% CI will be presented for selected efficacy endpoints. The standard survival analysis techniques of the Kaplan-Meier method will be utilized for time-to-event endpoints including duration of response, duration of response in...	[]
NCT01990534	8.1.6.1	Primary Efficacy Analysis	The primary efficacy endpoint is the overall ORR (CR + PR), by IRF assessment, in patients with relapsed or refractory classical HL who are considered to be not suitable for SCT or multiagent chemotherapy. The ORR by IRF assessment, and its two-sided 95% exact CI will be calculated by using the F distribution method.(...	[]
NCT01990534	8.1.6.2	Secondary Efficacy Analyses	The CR rate by IRF assessment will be derived and its two-sided 95% exact CI will be calculated by using the F distribution method.(27) Duration of response by IRF assessment, duration of response in the subset of patients with a CR, PFS by IRF assessment, and OS will be estimated by using the Kaplan-Meier methodology...	[]
NCT01990534	8.1.6.3	Additional Efficacy Analyses	PFS from the most recent prior treatment versus PFS as determined by the investigator from the current study will be presented by a Kaplan-Meier plot. will be analyzed in the same manner. CCI ![](_page_56_Picture_10.jpeg)	[ "Analysis of Other Efficacy Endpoints" ]
NCT01990534	8.1.8	Pharmacokinetics/Biomarkers	The PK of MMAE and total antibody (free antibody and ADC) will be derived from serum or plasma concentrations versus time data for all patients who met study inclusion criteria, received the study drug, and had evaluable and adequate PK data. The reporting of PK parameters will be determined on the basis of final par...	[ "Pharmacokinetic Analysis", "Immunogenicity" ]
NCT01990534	8.1.9	Safety Analysis	The safety population will be used for all safety analyses.	[]
NCT01990534	8.1.9.1	Adverse Events	Safety will be evaluated by the incidence of AEs, treatment-emergent AEs, severity and type of AEs, the summary of ECOG performance status score, and by changes from baseline in the patient's vital signs, weight, and clinical laboratory results. Exposure to study drug and reasons for discontinuation will be tabulated. ...	[ "Electrocardiogram Analysis" ]
NCT01990534	8.1.10	Interim Analysis	No formal interim analysis is planned for this study. f Use	[]
NCT01990534	9	STUDY COMMITTEES		[]
NCT01990534	9.1	Data Safety Monitoring Board	An independent data monitoring committee (IDMC) will not be required for this single-arm study.	[]
NCT01990534	10	ADVERSE EVENTS		[]
NCT01990534	10.1	Definitions		[]
NCT01990534	10.1.1	Pretreatment Event Definition	A pretreatment event is any untoward medical occurrence in a patient or subject who has signed informed consent to participate in a study but before administration of any study medication; it does not necessarily have to have a causal relationship with study participation.	[]
NCT01990534	10.1.2	Adverse Event Definition	Adverse event (AE) means any untoward medical occurrence in a patient or subject administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory findin...	[]
NCT01990534	10.1.3	Serious Adverse Event Definition	Serious AE (SAE) means any untoward medical occurrence that at any dose: Results in death. - Is life-threatening (refers to an AE in which the patient was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe). - Requires inpatient...	[]
NCT01990534	10.2	Procedures for Recording and Reporting Adverse Events and Serious Adverse Events	All AEs spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures will be recorded on the appropriate page of the eCRF (see Section [10.3](#page-62-1) for the period of observation). Any clinically r...	[ "SAE and Pregnancy Reporting Contact Information", "please refer to Section 15.4", "f Use" ]
NCT01990534	10.3	Monitoring of Adverse Events and Period of Observation	AEs, both nonserious and serious, will be monitored throughout the study as follows: - AEs will be reported from the time of administration of the first dose of the study drug through 30 days after administration of the last dose of study drug and recorded in the eCRFs. All events relating to peripheral neuropathy,...	[]
NCT01990534	10.4	Procedures for Reporting Drug Exposure During Pregnancy and Birth Events	If a woman becomes pregnant or suspects that she is pregnant while participating in this study, she must inform the investigator immediately and permanently discontinue study drug. The sponsor must also be contacted immediately by faxing a completed Pregnancy Form to the Millennium Department of Pharmacovigilance or de...	[]
NCT01990534	11	ADMINISTRATIVE REQUIREMENTS		[]
NCT01990534	11.1	Good Clinical Practice	The study will be conducted in accordance with the ICH-GCP and the appropriate regulatory requirement(s). The investigator will be thoroughly familiar with the appropriate use of the study drug as described in the protocol and the IB.	[]
NCT01990534	11.2	Data Quality Assurance	The investigator is required to prepare and maintain adequate and accurate case histories designed to record all observations and other data pertinent to the study for each study patient. Study data will be entered into an eCRF by site personnel using a secure, validated, web-based electronic data capture (EDC) applica...	[]
NCT01990534	11.3	Electronic Case Report Form Completion	Millennium or designee will provide the study sites with secure access to and training on the EDC application, sufficient to permit site personnel to enter or correct information in the eCRFs for the patients for whom they are responsible. eCRFs will be completed for each study patient. It is the investigator's respon...	[]
NCT01990534	11.4	Study Monitoring	Monitoring and auditing procedures developed or approved by Millennium will be followed to comply with GCP guidelines. All information recorded on the eCRFs for this study must be consistent with the patient's source documentation. During the course of the study, the study monitor will make study site visits to review...	[]
NCT01990534	11.6	Patient Information and Informed Consent	After the study has been fully explained, written informed consent will be obtained from either the patient or his/her guardian or legal representative before study participation. The method of obtaining and documenting the informed consent and the contents of the consent must comply with the ICH-GCP and all applicable...	[]
NCT01990534	11.7	Patient Confidentiality	To maintain patient privacy, all eCRFs, study drug accountability records, study reports, and communications will identify the patient by initials where permitted and/or by the assigned patient number. The patient's confidentiality will be maintained and will not be made publicly available to the extent permitted by th...	[]
NCT01990534	11.8	Investigator Compliance	The investigator will conduct the clinical study in compliance with the protocol provided by Millennium and given approval/favorable opinion by the IRB/IEC and the appropriate regulatory authority(ies). Modifications to the protocol are not to be made without agreement of both the investigator and Millennium. Changes t...	[]
NCT01990534	11.9	On-site Audits	Regulatory authorities, the IEC/IRB, and/or Millennium may request access to all source documents, eCRFs, and other study documentation for on-site audit or inspection. Direct access to these documents must be guaranteed by the investigator, who must provide support at all times for these activities.	[]
NCT01990534	11.10	Investigator and Site Responsibility for Drug Accountability	Accountability for the study drug at the study site is the responsibility of the investigator. Drug accountability records indicating the drug's delivery date to the site, inventory at the site, use by each patient, and amount returned to Millennium, or a designee (or disposal of the drug, if approved by Millennium) wi...	[]
NCT01990534	11.11	Product Complaints and Medication Errors	A product complaint is a verbal, written, or electronic expression that implies dissatisfaction regarding the identity, strength, purity, quality, or stability of a drug product. Individuals who identify a potential product complaint situation should immediately contact MedComm Solutions (see below) and report the even...	[ "For Product Complaints and Medication Errors," ]
NCT01990534	11.12	Closure of the Study	Within 90 days of the end of the study, the sponsor will notify the competent authorities and the IECs in all member states where the study is being carried out that the study has ended. Within 1 year of the end of the study, a summary of the clinical study results will be submitted to the competent authorities and IE...	[]
NCT01990534	11.13	Record Retention	The investigator will maintain all study records according to the ICH-GCP and applicable regulatory requirement(s). Records will be retained for at least 2 years after the last marketing application approval or 2 years after formal discontinuation of the clinical development of the investigational product or according ...	[]
NCT01990534	12	USE OF INFORMATION	All information regarding brentuximab vedotin supplied by Millennium to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Millennium. It is understood that there is an obligatio...	[]
NCT01990534	13	INVESTIGATOR AGREEMENT	I have read Protocol C25007: A Single-arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Are Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy. \| Conference on Harmonisation Guidelines for Good Clinical Practice and applicableregulatory requirements and to...	[]
NCT01990534	14	REFERENCES	- 1. Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. Journal of Clinical Oncology 2007;25(5):579-86. - 2. Pizzolo G, Romagnani S. CD30 molecule (Ki-1 Ag): more than just a marker of CD30+ lymphoma. Haematologica 1995;80(4):357-66. - 3. Horie ...	[]
NCT01990534	15	APPENDICES		[]
NCT01990534	15.1	Response Definitions for Clinical Studies	\| Response \| Definition \| Nodal Masses ...	[]
NCT01990534	15.2	Eastern Cooperative Oncology Group (ECOG) Scale for Performance Status	\| Grade \| Description \| \|-------\|----------------------------------------------------------------------------------------------------------------------...	[]
NCT01990534	15.3	New York Heart Association Classification of Cardiac Disease	\| \| GradeDescription ...	[]
NCT01990534	15.4	Serious Adverse Event and Pregnancy Reporting Contact Information	![](_page_74_Picture_10.jpeg) Clinical Study Protocol C25007, EudraCT: 2013-00232-10 - 1. Get a line with dial tone - 2. Dial the Worldwide access number (international toll free number listed) \| \| To place a call using World Phone (WP)1.Get a line with dial tone2.3. \| Dial the Worldwide access number (inte...	[ "Phone/ Helpline Instructions", "Brentuximab Vedotin (ADCETRIS® )", "International (Countries Outside United States & Canada)", "Reporting via Fax", "ELECTRONIC SIGNATURES" ]
NCT02261727	1	Chief Investigators	Chief Investigators are members of the Steering Committee. Prof Norbert Berend Prof Christine Jenkins Prof Peter Barnes Prof Bartolome Celli Prof John Seale The Chief Investigators are responsible for implementing the study protocol. The Steering Committee is responsible for ensuring that study implementation is cons...	[ "Responsibilities:" ]
NCT02261727	2	Sponsor and Contacts	The George Institute for Global Health Missenden Road Camperdown NSW 2050 Australia Prof Norbert Berend The George Institute for Global Health Level 13, 321 Kent Street Sydney NSW 2000 Australia Email: [norbert.berend@sydney.edu.au](mailto:norbert.berend@sydney.edu.au) Prof Christine Jenkins Study Director and Lea...	[ "Sponsor", "Chief Investigator", "International Coordinating Centre", "1. Chief Investigator's Signature" ]
NCT02261727	2	Participating Centre Investigator Signature	I have read this protocol and agree that it contains all necessary details for carrying out the study as described. I will conduct this protocol as outlined therein, including all statements regarding confidentiality. I will make all reasonable efforts to complete the study within the time designated. I will provide co...	[]
NCT02261727	3	List of Abbreviations	\| Abbreviation \| Term \| \|--------------\|------------------------------------------------\| \| ACTH \| Adrenocorticotropic Hormone \| \| AE \| Adverse Event \| \| ATS \| American Thoracic Society ...	[]
NCT02261727	4	Synopsis	\| Study Title \| Low dose corticosteroids and theophylline in the treatment ofCOPD –the TASCS Study (Theophylline and Steroids inCOPD Study) ...	[]
NCT02261727	5	Schedule of Study Tests, Procedure and Visits	Table 1 Schedule of Study Tests, Procedures and Visits \| Assessment Description \| Screening24weeksprior torandomisation \| Baseline/Randomisation(Week 0) \| 6,18,30,42weeks(phone) \| 12weeks \| 24weeks \| 36weeks \| 48weeks \| 50weeks \| \|-------------------------------------------------\|-------------...	[]
NCT02261727	6	Administrative Structure		[]
NCT02261727	6.1	International Coordinating Centre	6.1 International Coordinating Centre The International Coordinating Centre (ICC) is based at The George Institute for Global Health. The ICC has responsibility for the overall management of the study including the following: assistance with HREC applications, management of study budget, liaison with funding bodies;...	[]
NCT02261727	6.2	Data Management	6.2 Data Management Data management will be provided by The George Institute for Global Health and the principle means of data collection and data processing will be electronic via the Internet. All computerised forms will be electronically signed by the authorised study staff and all changes made following the elec...	[]
NCT02261727	6.3	Clinical Centres	6.3 Clinical Centres Individual clinical centres will manage the study at their own centre in accordance with the study protocol. Additionally, the individual centres will manage: - protocol education of staff members involved in the study, - participant recruitment, - data collection, storage and data transfer - s...	[]
NCT02261727	7	Funding and Insurance	The study is funded by a National Health and Medical Research Council of Australia Project Grant and by seeding grants from The George Institute for Global Health and the George Foundation. ![](_page_15_Picture_0.jpeg) Protocol Number: TGI-Resp-01 The study was designed by the Principal Investigators, and initiated ...	[]
NCT02261727	8	Study Background		[]
NCT02261727	8.1	Burden of Disease	8.1 Burden of Disease Chronic obstructive pulmonary disease (COPD) accounts for a large proportion of the global burden of death and disability and is projected to rise even further over the next few decades. Strategies for the prevention of COPD, such as tobacco control and reduction in indoor smoke pollution, are ...	[]

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