protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT03860077 | 10 | Week 4 Session | 10. Week 4 Session a. Purpose: This laboratory session will evaluate end-point responses on behavioral economic measures and allow for collection of final biomarkers and cigarette collection.
PIs: Cassidy & Colby - b. Procedures: At the beginning of the session, participants will provide a breath CO sample, complete a... | [
"PIs: Cassidy & Colby"
] |
NCT03860077 | 11 | Outcomes, Measures Justification, Descriptions, and Schedule | 11. Outcomes, Measures Justification, Descriptions, and Schedule
Primary Outcomes - Cigarettes smoked per day - Amount of total alternative product (ATP) use
Secondary Outcomes - Amount of combustible and amount of noncombustible ATP use - Toxicant exposure (total nicotine equivalents and NNAL) - FEV outcomes
Explor... | [
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NCT03860077 | 14 | Risks and Benefits. Potential risks and benefits for participants | 14. Risks and Benefits. Potential risks and benefits for participants a. Subjective discomfort (survey questionnaires): The protocol includes survey questions about medical history, drug and alcohol use, and questionnaires about mood. Answering these personal questions could make the participant feel uncomfortable. How... | [
"PIs: Cassidy & Colby"
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NCT03860077 | 15 | Adverse Events | 15. Adverse Events
a. Collection and reporting of AEs and SAEs While participating in the trial, adverse events and changes in medications will be assessed at every study visit and carbon monoxide will be obtained. Medical events will typically be
PIs: Cassidy & Colby identified during the administration of the Healt... | [
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"The following will be monit... |
NCT03887117 | 1 | As Exposed Exercise Compliant Set | 1. As Exposed Exercise Compliant Set The As Exposed Exercise Compliant Set (AEECS) consists of all randomized subjects who have at least one valid non-safety assessment after randomization, specifically we have - x post-randomization product (cigarette or IQOS) use experience if randomized to IQOS, IQOS-2 or cigarette ... | [] |
NCT03887117 | 2 | Full Analysis Set | 2. Full Analysis Set The Full Analysis Set (FAS) consists of all randomized subjects who have at least one postrandomization product (cigarette or IQOS) use experience if randomized to IQOS, IQOS-2 or cigarette arm, and who have at least one valid non-safety assessment after randomization. All subjects in the SA arm wh... | [] |
NCT03887117 | 3 | Safety Set | 3. Safety Set
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 15 of 151 The Safety Set consists of all subjects enrolled with signed ICF who have at least one valid safety assessment during the course of the study. The Safety Set will be analyzed by actual exposure (product use exposure).
Endpoin... | [
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NCT03887117 | 3 | STUDY OBJECTIVES | 3 STUDY OBJECTIVES | [] |
NCT03887117 | 3.1 | Objectives and Endpoints | 3.1 Objectives and Endpoints The objectives of this study are:
Objective 1. To evaluate changes in VO2max in subjects switching to IQOS (with and without training), continuing to smoke cigarettes (with training) and being smoking abstinent (with training)
Endpoint (V3, V4 and V43) - x VO2max as determined during maxi... | [
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NCT03887117 | 4 | INVESTIGATIONAL PLAN | 4 INVESTIGATIONAL PLAN | [] |
NCT03887117 | 4.1 | Overall Study Design and Plan | 4.1 Overall Study Design and Plan This is a randomized, controlled, open-label, 4-arm parallel group study with stratification by daily cigarette consumption over the last 12 months prior to V1 as reported during V1 (i.e., 10 to 19 cigarettes or >19 cigarettes per day) and sex (Figure 2). A sufficient number of healthy... | [
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NCT03887117 | 4.2 | Rationale for Study Design | 4.2 Rationale for Study Design PMI is now launching a series of new clinical studies to better understand the additional benefits the reduced exposure of IQOS can offer to its consumers. Because of the recognized adverse effects of smoking on exercise capacity, this exploratory study is part of the program. The overall... | [
"Confidentiality Statement"
] |
NCT03887117 | 4.3 | Appropriateness of Measurements | 4.3 Appropriateness of Measurements The VO2max test is the only direct test to determine maximal oxygen uptake in humans and is considered to be the metric that defines the limits of the cardiopulmonary system (50). To assess exercise performance in this study, a laboratory-based exercise capacity test will be performe... | [
"Confidentiality Statement"
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NCT03887117 | 4.4 | Study Duration | 4.4 Study Duration The study duration per subject will be between approximately 20-25 weeks depending on length of visit windows. The study consists of a 1-28-day screening period (V1), a 1-day familarization visit (V2), up to 7±1 days interval between V2 and V3, followed by a 1-day baseline and randomization visit (V3... | [
"Confidentiality Statement"
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NCT03887117 | 5 | STUDY POPULATION | 5 STUDY POPULATION | [] |
NCT03887117 | 5.1 | Selection of Study Population | 5.1 Selection of Study Population | [] |
NCT03887117 | 5.1.1 | Inclusion Criteria | 5.1.1 Inclusion Criteria Subjects who meet all the following inclusion criteria can be enrolled into the study: | | Inclusion Criteria | Rationale | Screening | EnrollmentV2 | |----|------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03887117 | 5.1.2 | Exclusion Criteria | 5.1.2 Exclusion Criteria Subjects who meet any of the following exclusion criteria must not be enrolled into the study: | | Exclusion Criteria | Rationale | Screening | EnrollmentV2 | |----|----------------------------------------------------------------------------------------------------------------------------------... | [
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NCT03887117 | 5.2 | Discontinuation of Subjects from the Study | 5.2 Discontinuation of Subjects from the Study Discontinued subjects will include both, subjects who withdraw from the study (subject's decision) and subjects who are discontinued from the study by the decision of the Investigator. A subject can only be discontinued from the study after enrollment. Subjects will be inf... | [
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NCT03887117 | 5.3 | Lost to Follow-up | 5.3 Lost to Follow-up The date of the last contact with the subject (e.g., last visit, last phone call) should be recorded in the source document. After the last contact, reasonable number of attempts to contact the subject (including written correspondence and phone calls) should be done and documented in the source d... | [
"Confidentiality Statement"
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NCT03887117 | 5.4 | Violation of Selection Criteria | 5.4 Violation of Selection Criteria Subjects who violate the entry criteria prior to enrollment will be considered as screening failures. Re-screening of these subjects will not be permitted.
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 52 of 151 | [
"Confidentiality Statement"
] |
NCT03887117 | 6 | INVESTIGATIONAL PRODUCTS/ REFERENCE ARM | 6 INVESTIGATIONAL PRODUCTS/ REFERENCE ARM | [] |
NCT03887117 | 6.1 | Description of Investigational Products | 6.1 Description of Investigational Products | [] |
NCT03887117 | 6.1.1 | Test Product | 6.1.1 Test Product The product tested in this study is the Tobacco Heating System with Heatsticks, marketed in Germany under the brand name IQOS and referred to as IQOS in this protocol. All versions of IQOS and Heatsticks available for sale in Germany at the time of study start or becoming available during the course ... | [
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NCT03887117 | 6.1.2 | Comparator and Baseline Product | 6.1.2 Comparator and Baseline Product Cigarette (comparator product): subjects's own preferred brand of commercially available cigarettes. | [] |
NCT03887117 | 6.2 | Packaging and Labeling | 6.2 Packaging and Labeling An IQOS starter kit (i.e., IQOS device and a selection of HeatSticks variants available on the German market) will be supplied to the site by the Sponsor or authorized representative in packages that protect against deterioration during transport and storage.
Confidentiality Statement P1-EXC... | [
"Confidentiality Statement"
] |
NCT03887117 | 6.3 | Use of Investigational Product(s) | 6.3 Use of Investigational Product(s) The study is designed as an ad libitum use study. The subjects will be allowed to use their allocated products (cigarette or IQOS) according to their need. There will be no restrictions on the variants of HeatSticks used. | [] |
NCT03887117 | 6.3.1 | From Enrollment to Randomization | 6.3.1 From Enrollment to Randomization From screening visit (V1) to randomization (V3), all subjects will be allowed to continue smoking ad libitum their preferred usual brand of cigarettes. 30-60 min before start of baseline VO2 max at V3, subjects will smoke a cigarette. However, subjects will never be forced to smok... | [] |
NCT03887117 | 6.3.2 | Investigational Period | 6.3.2 Investigational Period | [] |
NCT03887117 | 6.3.2.1 | IQOS arms | 6.3.2.1 IQOS arms IQOS arm: subjects randomized into IQOS-1 and IQOS-2 arms will be instructed to use exclusively IQOS ad libitum. The switch to different variants of HeatSticks as well as the use of other tobacco- or nicotine-containing products will not lead to discontinuation (see Section 5.2). 30-60 min before star... | [
"Confidentiality Statement"
] |
NCT03887117 | 6.3.2.2 | Cigarette arm | 6.3.2.2 Cigarette arm Cigarette arm: subjects randomized to the cigarette arm will be instructed to continue smoking their cigarettes ad libitum. The switch to different cigarette brands and the use of other tobaccoor nicotine-containing products will not lead to discontinuation (see Section 5.2). 30-60 min before star... | [] |
NCT03887117 | 6.3.2.3 | SA arm | 6.3.2.3 SA arm SA arm: As of randomization on V3 until V43, subjects in the SA arm will be instructed to abstain from smoking cigarettes or using any other tobacco- or nicotine-containing products. Use of NRT will be allowed as per subjects request and will be provided by the site. If NRT patches are used they should b... | [] |
NCT03887117 | 6.3.3 | Safety Follow-up Period | 6.3.3 Safety Follow-up Period During the safety follow-up period (i.e. as of V44 or prematurely discontinued), all subjects will be free to smoke their own cigarettes, or use any other nicotine-containing product of their choice. | [] |
NCT03887117 | 6.3.4 | Stopping rules for Investigational Product | 6.3.4 Stopping rules for Investigational Product For safety purposes, use of the IP should be temporarily reduced or stopped in the event of any signs suggesting nicotine overexposure, e.g., gastrointestinal disturbance (nausea, vomiting, diarrhea, stomach, or abdominal pain), cold sweats, headache, dizziness, and brea... | [] |
NCT03887117 | 6.4 | Method for Assigning Subjects to Study Arms | 6.4 Method for Assigning Subjects to Study Arms Randomization will be done through the Interactive Web and Voice Response System (IXRS) at any time during the visit. Subjects will be informed about their study arm allocation at the end of V3. Subjects will be randomized in one of the four study arms: - x Cigarette arm ... | [
"Confidentiality Statement"
] |
NCT03887117 | 6.5 | Blinding | 6.5 Blinding | [] |
NCT03887117 | 6.5.1 | Blinding of site staff | 6.5.1 Blinding of site staff This is an open-label study and the site staff performing study assessments will therefore not be blinded by the smoking status. | [] |
NCT03887117 | 6.5.2 | Blinding of data | 6.5.2 Blinding of data There will be additional, even though limited, degree of blinding during the conduct of the study, including the data review and data analysis process. In particular, PMI and contract research organization (CRO) personnel will be blinded as summarized in Table 2
Table 2 Blinding | Blinded Study ... | [
"Table 2 Blinding"
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NCT03887117 | 6.6 | Investigational Product Accountability and Adherence | 6.6 Investigational Product Accountability and Adherence | [] |
NCT03887117 | 6.6.1 | Dispensing Investigational Product | 6.6.1 Dispensing Investigational Product Due to the lack of availability of the device in physical stores in the study area subjects allocated to the IQOS arms will be supplied with an IQOS starter kit (IQOS device and a
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 57 of 151 selection of HeatSt... | [
"Confidentiality Statement"
] |
NCT03887117 | 6.6.2 | Storage and Accountability | 6.6.2 Storage and Accountability The Investigator or a designated study collaborator will be responsible for the storage and accountability of the IQOS devices and HeatSticks to be distributed only once at V3, together with the device. The IQOS devices (charger and holder) as well as HeatSticks (to be distributed only ... | [] |
NCT03887117 | 6.6.3 | Investigational Product Retention | 6.6.3 Investigational Product Retention The subjects will return the IQOS device (Charger and Holder), including replacement devices to the study site at V43 or upon early discontinuation. The study site will return to the Sponsor or authorized representative the IQOS device (Charger and Holder) upon study completion. ... | [] |
NCT03887117 | 6.6.4 | Adherence to Investigational Products and Reference Arm | 6.6.4 Adherence to Investigational Products and Reference Arm Adherence to the allocated product or reference arm will be monitored using self-reported tobacco and nicotine containing product use as reported in the product use diary (Section 7.11.8).
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page... | [
"Confidentiality Statement"
] |
NCT03887117 | 6.7 | Restrictions | 6.7 Restrictions | [] |
NCT03887117 | 6.7.1 | Product Use Restrictions | 6.7.1 Product Use Restrictions There will be no restriction on allocated product use. | [] |
NCT03887117 | 6.7.2 | Dietary Restrictions | 6.7.2 Dietary Restrictions Subejcts will be asked not to consume any caffeine- or alcohol-containing products 12 h prior to VO2max and exercise capacity test. Before safety laboratory and biological health markers blood collections at V3, V14, V28, V43 and V44 subjects will be required to fast for at least 8 h. | [] |
NCT03887117 | 6.8 | Concomitant Medication | 6.8 Concomitant Medication Medications will be allowed and carefully monitored during the study by the Investigator or designee. The Investigator or designee is responsible for the medical care including medication of the subjects during their participation in the study. Any decisions regarding the prescription of medi... | [
"Confidentiality Statement"
] |
NCT03887117 | 7 | STUDY PROCEDURES | 7 STUDY PROCEDURES Personnel performing or recording study measurements must have appropriate and fully documented training. Quality control (QC) measures must be defined, implemented and documented. All study procedures are provided as an overview in the schedule of events (Appendix 1). In this section, only the expec... | [] |
NCT03887117 | 7.1 | Informed Consent | 7.1 Informed Consent Prior to any study assessment being performed, the subjects will be asked to provide his/her written consent to participate to the study (ICF) (Section 1.3.). During the consent process, the Investigator or designee obtaining consent must inform each subject of the nature, risks and benefits of, an... | [] |
NCT03887117 | 7.2 | Information on the Risk of Smoking and Smoking Cessation Advice and Debriefing on IQOS | 7.2 Information on the Risk of Smoking and Smoking Cessation Advice and Debriefing on IQOS All subjects included in the study will be advised that the best way of preventing the development of smoking-related diseases is to stop smoking. Only subjects who are not planning to quit smoking cigarettes will be eligible for... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.3 | Questions on Smoking History/Habits and Plan to Quit Smoking. | 7.3 Questions on Smoking History/Habits and Plan to Quit Smoking. Subject will be questioned for their smoking history and self-reported current tobacco and nicotine containing product use over the past 12 months at V1. The subject will also be asked if he/she is planning to quit smoking within 6 months after V1. This ... | [] |
NCT03887117 | 7.4 | Demonstration of IQOS | 7.4 Demonstration of IQOS IQOS including HeatSticks will be presented to all subjects by the Investigator or designated study collaborator at V1. | [] |
NCT03887117 | 7.5 | Clinical Assessments | 7.5 Clinical Assessments | [] |
NCT03887117 | 7.5.1 | Demographic Data | 7.5.1 Demographic Data Demographic data (sex, date of birth, race) will be recorded at V1. | [] |
NCT03887117 | 7.5.2 | Medical History, Concomitant Disease, Previous and Ongoing Medications | 7.5.2 Medical History, Concomitant Disease, Previous and Ongoing Medications Relevant medical history and any concomitant disease will be documented at V1. Medical history is defined as any condition that started and ended prior to ICF signature. A concomitant disease is defined as any condition that started prior to I... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.5.3 | Physical Examination | 7.5.3 Physical Examination A full physical examination will include review of general appearance, skin, head, eyes, ears, nose and throat, thyroid gland, chest, lungs, back, abdomen, dentition, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. The physical examination is to be conducted by the... | [] |
NCT03887117 | 7.5.4 | Body Height, Weight and Body Mass Index (BMI) | 7.5.4 Body Height, Weight and Body Mass Index (BMI) Body height and weight will be recorded and BMI will be calculated using the following formula: $$Weight in kilograms \\ BMI = \frac{}{} \qquad \qquad (kg/m^2) \\ height in meters^2$$ The BMI will be used to assess eligibility for enrollment at V1. The fat-free weight... | [] |
NCT03887117 | 7.5.5 | Vital Signs | 7.5.5 Vital Signs Systolic and diastolic blood pressure, pulse rate and respiratory rate will be recorded. All measurements will be made in supine position after the subject has rested for at least 5 minutes in a supine position. The subject should have abstained from smoking or using IQOS for at least 15 minutes prior... | [] |
NCT03887117 | 7.5.6 | Spirometry | 7.5.6 Spirometry All personnel performing spirometry testing must have the appropriate training with the record of the training. Quality control measures should be available and be properly documented.
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 62 of 151 The spirometry test will be performed ... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.5.7 | Electrocardiogram | 7.5.7 Electrocardiogram ECG testing will be performed as per the site's local practice. A standard 12-lead ECG will be recorded after the subject has rested for at least 10 minutes in a supine position. The following parameters will be documented: heart rate, PR interval, QRS interval, QT interval, and QT interval corr... | [] |
NCT03887117 | 7.5.8 | Body-fat Percentage and Waist Circumference | 7.5.8 Body-fat Percentage and Waist Circumference Body-fat percentage based on skinfold caliper measurements and waist circumference will be performed as per the site's practice. Mesurements should be performed by the same trained site collaborator and using the same instrument. | [] |
NCT03887117 | 7.5.9 | Determination of Blood Composition and Volume | 7.5.9 Determination of Blood Composition and Volume Hemoglobin mass (Hbmass) will be quantified using an automated system (e.g. OpCO, Detalo Instruments, Denmark or similar). First, a venous blood sample will be drawn to measure hemoglobin, hematocrit and COHb, after which the CO re-breathing procedure will be performe... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.6 | Exercise Testing and Training | 7.6 Exercise Testing and Training | [] |
NCT03887117 | 7.6.1 | VO2max Test and Blood Lactate Levels | 7.6.1 VO2max Test and Blood Lactate Levels Subjects will perform an incremental cycling test to volitional fatigue on an electronically braked cycle ergometer (such as Monark E839, Varberg, Sweden). To measure oxygen uptake and determine VO2max an online gas collection system (e.g. COSMED CPET) will be used where O2 an... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.6.2 | Exercise Capacity Test | 7.6.2 Exercise Capacity Test Subjects will perform an exercise capacity test during which they will complete a given workload as quickly as possible. The criteria for completion of the test is the completing of a pre-defined relative work determined based on the highest wattage level reached at VO2max test times 1.25 (... | [] |
NCT03887117 | 7.6.3 | Exercise Training | 7.6.3 Exercise Training Subjects randomized into the IQOS-1, cigarette and SA arms will participate in a 12-week training program consisting of 38 training sessions (V5-V42). All training sessions will be performed at the investigational site using stationary bikes, and will be supervised by designated site personnel. ... | [] |
NCT03887117 | 7.7 | Biomarker Assessment | 7.7 Biomarker Assessment | [] |
NCT03887117 | 7.7.1 | Exhaled Carbonmonoxide (CO) | 7.7.1 Exhaled Carbonmonoxide (CO) Carbon monoxide (CO) in exhaled breath will be measured using the a Smokerlyzer® device, such as the Micro 4 Smokerlyzer® or similar. At V1 and V2, a cut-off of >6 ppm for confirming cigarette smoking status will be applied (56)(57). | [] |
NCT03887117 | 7.7.2 | Carboxyhemoglobin (COHb) | 7.7.2 Carboxyhemoglobin (COHb) Venous blood samples will be collected and COHb measured by a designated laboratory.
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 65 of 151 | [
"Confidentiality Statement"
] |
NCT03887117 | 7.7.3 | Urine Biomarkers of Exposure | 7.7.3 Urine Biomarkers of Exposure Spot urine will be collected to measure concentrations of NEQ, NNAL, CEMA and creatinine. The urine collection should be performed as late as possible during the day. | [] |
NCT03887117 | 7.7.4 | Biological Health Markers in Blood | 7.7.4 Biological Health Markers in Blood Venous blood samples will be collected for measurement of HDL, LDL, VLDL, hs-CRP, GH and HbA1c (%). Blood samples will be taken after at least 8 hours of fasting (Section 6.7.2). | [] |
NCT03887117 | 7.8 | Laboratory Assessments | 7.8 Laboratory Assessments | [] |
NCT03887117 | 7.8.1 | Clinical Chemistry, Hematology, and Urinalysis for Safety Panel | 7.8.1 Clinical Chemistry, Hematology, and Urinalysis for Safety Panel Hematology, clinical chemistry, serology and urinalysis safety panel will be measured at local laboratory except for urine drug screening, urine cotinine screening,, alcohol breath test and urine pregnancy test, these tests will be performed at site ... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.8.2 | Serology | 7.8.2 Serology At V1, a test for hepatitis B (HbsAg), hepatitis C (HCV antibody), and human immunodeficiency virus (anti-HIV1/2) will be performed. In case of positive results, the subject will be referred to appropriate medical care. | [] |
NCT03887117 | 7.8.3 | Urine Drug Screening | 7.8.3 Urine Drug Screening At V1 and V2, urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, methadone, methamphetamines, phencyclidine, tricyclic antidepressants) will be performed by the personnel at the investigational site. | [] |
NCT03887117 | 7.8.4 | Urine Cotinine Screening | 7.8.4 Urine Cotinine Screening At V1 and V2, a urine dip-stick cotinine test with a threshold of ≥ 200 ng/mL will be performed at the investigational site to confirm subject's smoking status.
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 67 of 151 | [
"Confidentiality Statement"
] |
NCT03887117 | 7.8.5 | Alcohol Breath Test | 7.8.5 Alcohol Breath Test At V1 and V2, a breath alcohol test will be performed at the investigational site using a breathalyzer device. | [] |
NCT03887117 | 7.8.6 | Urine Pregnancy Test | 7.8.6 Urine Pregnancy Test A urine pregnancy test will be done at the investigational site for all female subjects at V1-V3 V5, V14, V28 and V44. Subjects with a positive pregnancy test at V1 or at V2 will not be enrolled and will be considered screening failures. In any case of a positive urine pregnancy test, the Inv... | [] |
NCT03887117 | 7.9 | Sample Handling, Storage, and Shipment | 7.9 Sample Handling, Storage, and Shipment Detailed procedures for sample collection and handling of samples are described in the laboratory manual. Safety laboratory samples will be destroyed as per the laboratory's standard procedures. For blood and urine samples collected for biological health marker and exposure ma... | [] |
NCT03887117 | 7.9.1 | Blood Samples | 7.9.1 Blood Samples Venous blood samples will be collected by qualified and trained site personnel. Subjects should be in a seated position during blood collection. The maximal volume of blood drawn for each subject will be approximately 235 mL, which includes approximately 55 mL for safety and serology analysis, appro... | [] |
NCT03887117 | 7.9.2 | Urine Samples | 7.9.2 Urine Samples Spot urine samples will be used for the urine drug screen, urine cotinine screen, urine pregnancy test, safety urinalysis, NEQ, NNAL, CEMA and creatinine analysis, and for biobanking.
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 68 of 151 | [
"Confidentiality Statement"
] |
NCT03887117 | 7.9.3 | Long-Term Storage (Biobanking) | 7.9.3 Long-Term Storage (Biobanking) If a subject gives consent for biobanking, additional samples of urine, blood, plasma, saliva will be collected at V3, V14, V28 and V43, and sweat at V3 and V43.
Urine: Samples will be collected from the spot urine for: - x lipidomic profiling: 2 x approximately 2 mL - x proteomic ... | [
"Urine:",
"Whole blood:",
"Saliva:",
"Sweat:"
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NCT03887117 | 7.10 | Mobile Health (mHealth) Wearable | 7.10 Mobile Health (mHealth) Wearable Subjects will wear a mHealth device (Vivofit 3, Garmin), which is worn on the wrist, for the recording of their physical activity including daily step count and intensity minutes. Three intensity levels of physical activity will be recorded; 1) sedentary - little to no activity mon... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.11 | Questionnaires | 7.11 Questionnaires | [] |
NCT03887117 | 7.11.1 | Fagerström Test for Nicotine Dependence (Revised Version) | 7.11.1 Fagerström Test for Nicotine Dependence (Revised Version) Subjects will complete the FTND questionnaire in its revised version (58). The questionnaire consists of six questions. The FTND total score determines the subject's dependence on nicotine in three levels: mild (0-3 points), moderate (4-6 points), and sev... | [] |
NCT03887117 | 7.11.2 | Product preference | 7.11.2 Product preference On V3, the following question will be asked to all subjects "Which product would you prefer to be randomized to?" - x IQOS - x Cigarette - x Smoking abstinence - x No preference The product preference question needs to be asked before randomization. As an instruction to answer this question, s... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.11.3 | Lifestyle questionnaire | 7.11.3 Lifestyle questionnaire Subjects will be asked questions to capture baseline covariates such as, diet, alcohol intake, sleep deficit, and exposure to passive smoking at V3. | [] |
NCT03887117 | 7.11.4 | Assessment of Cough-VAS and Likert Scales | 7.11.4 Assessment of Cough-VAS and Likert Scales Subjects will assess cough on a Visual Analogue Scale (VAS) and on three Likert scales. Subjects will be asked if they have experienced a regular need to cough (e.g., whether they have coughed several times in the previous 24 hours prior to assessment). If the answer is ... | [] |
NCT03887117 | 7.11.5 | International Physical Activity Questionnaire (IPAQ) - short form | 7.11.5 International Physical Activity Questionnaire (IPAQ) - short form At V1 subjects' physical activity levels will be assessed using the short version of the IPAQ. This questionnaire was developed by a group of experts in 1998 to facilitate surveillance of physical activity based on a global standard (59). The IPAQ... | [
"Confidentiality Statement"
] |
NCT03887117 | 7.11.6 | Borg Rate of Perceived Exertion (RPE) Scale | 7.11.6 Borg Rate of Perceived Exertion (RPE) Scale During VO2max test (only at V3 and V43) subjects will rate their perceived exertion on the Borg RPE scale at rest and then at each 25W increase (61). The Borg RPE scale is a way of measuring physical activity intensity level. It is based on the physical sensations a pe... | [] |
NCT03887117 | 7.11.7 | Rate of Perceived Capacity (RPC) Scale | 7.11.7 Rate of Perceived Capacity (RPC) Scale To predict maximal exercise capacity, the rating of perceived capacity (RPC) scale was developed based on metabolic equivalents (METs) (62). MET values from 1 to 20 for men and 1 to 18 for women are listed on a progressive scale and linked to physical activities. Subjects w... | [] |
NCT03887117 | 7.11.8 | Product Use Diary | 7.11.8 Product Use Diary Subjects will enter the number of HeatSticks, cigarettes, or/and other tobacco and nicotinecontaining products used per day in a product use diary from V2 until the discharge at V43. Before the diary is delivered to the subjects, subjects will be trained by site staff on how to complete it. The... | [] |
NCT03887117 | 7.11.9 | Qualitative Interviews on Health and Functioning (sub-study) | 7.11.9 Qualitative Interviews on Health and Functioning (sub-study) Subjects that have signed the optional section of the ICF for the sub-study on health on functioning will have a one-hour, qualitative interview over the phone or computer between
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NCT03887117 | 8 | ADVERSE EVENTS | 8 ADVERSE EVENTS | [] |
NCT03887117 | 8.1 | Definitions | 8.1 Definitions | [] |
NCT03887117 | 8.1.1 | Adverse Events | 8.1.1 Adverse Events An adverse event is defined as any health-related event which is adverse or unfavorable and which either starts after ICF signature or represents a worsening of a health – related condition that existed at the time of that signature. Careful medical judgment is required to establish whether a clini... | [] |
NCT03887117 | 8.1.2 | Serious Adverse Events | 8.1.2 Serious Adverse Events A serious adverse event (SAE) is defined as an AE that: - x Results in death, - x Is life-threatening, - x Requires inpatient hospitalization or prolongation of existing hospitalization, - x Results in persistent or significant disability/incapacity, - x Is a congenital anomaly/birth defect... | [
"7.1.3. Conditions Existent Before the Start of the Period of Collection of AEs (ICF Signature)",
"Confidentiality Statement"
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NCT03887117 | 8.2 | Assessment of Adverse Events | 8.2 Assessment of Adverse Events | [] |
NCT03887117 | 8.2.1 | Collection of Information | 8.2.1 Collection of Information Any non-serious AE occurrence during the study must be documented in the subject's medical records in accordance with the Investigator's normal clinical practice and on the AE page of the CRF. SAEs that occur during the study must be documented in the subject's medical record, on the AE ... | [] |
NCT03887117 | 8.2.2 | Period of Collection | 8.2.2 Period of Collection AEs (including SAEs) will be collected from the time of ICF signature until the EOS. Any AEs which occur during the screening period will be captured by the study site staff and assessed by the Investigator or designee(s) in order to establish relationship to study procedures.
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"Confidentiality Statement"
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