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The present study will explore the patients satisfaction to COPD medical treatment (i.e. pharmacological and not pharmacological treatment) in a clinical real-world setting and how the satisfaction for medical treatment is related to clinical parameters, quality of life, illness perception and treatment adherence evolution.
Moreover health care resource consumption will be observed during the observation period.
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| Measure | Description | Time Frame |
|---|---|---|
| The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Patient's self-reported satisfaction or dissatisfaction with pharmacological treatments was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4, a validated instrument. The TSQM has total 9 items (TSMQ-9) with responses to nearly all items rated on a 5-point or 7-point rating scale that provide scores on 3 scales: effectiveness (items #1 #2 #3), convenience (items #4 #5 #6) and global satisfaction (items #7 #8 #9). The TSQM-9 domain scores were calculated as recommended by the instrument authors. (i) Effectiveness = [(item1 + item2 + item3) - 3]/18*100, (ii) Convenience = [(item4 + item5 + item6) - 3]/18*100 and (iii) Global satisfaction = [(item7 + item8 + item9) - 3]/14*100. Each domain score can be calculated only if all the three items considered in the calculation of that score are not missing. The TSQM-9 domain scores range from 0 to 100, with higher scores representing higher satisfaction on that domain. | At enrollment visit, 6-month follow-up visit and 12-month follow-up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | Patient's disease perception was evaluated by Brief Illness Perception Questionnaire (B-IPQ) consist 8 questionnaires rated 1 - 10 response scale. Mean total score ranges from 8-80, where a greater score indicated a more threatening view of COPD. Adherence was measured using Morisky Medication Adherence Scale, 4 items (MMAS-4) questionnaire which consists of 4 questions. Items are summed to give an adherence score ranging from 0 to 4, where a higher score indicated a greater adherence grade. Patients' health status was measured using the COPD Assessment Test (CAT) questionnaire that consists of 8-items in which patients can choose a score from 0 to 5. The total score ranges from 0 to 40, where a higher score indicated a worst impact of symptoms on the patient's daily activities. Dyspnea was measured using Modified Medical Research Council Dyspnea Scale (MMRC) with a 0-to-4 grading system. It had 0-to-4 grading system, with higher score indicating a higher level of dyspnea. |
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Inclusion criteria:
Exclusion criteria:
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COPD pts
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Alessandria | 15121 | Italy | |||
| I.N.R.C.A. - I.R.C.C.S Ospedale Geriatrico Ugo Sestili |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31760881 | Derived | Contoli M, Rogliani P, Di Marco F, Braido F, Corsico AG, Amici CA, Piro R, Sarzani R, Lessi P, Scognamillo C, Scichilone N, Santus P; SAT Study Group. Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619888128. doi: 10.1177/1753466619888128. | |
| 31174106 |
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All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria were not met.
This was a multi-center, non-interventional (observational), prospective cohort study based mainly on newly-collected data for Chronic obstructive pulmonary disease (COPD) patients. No treatments were administered to the patients on the protocol basis, since this was a non-interventional study. The total number of enrolled patients was 401.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total COPD Patients | Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total COPD Patients | Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of signing informed consent form is presented. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Patient's self-reported satisfaction or dissatisfaction with pharmacological treatments was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4, a validated instrument. The TSQM has total 9 items (TSMQ-9) with responses to nearly all items rated on a 5-point or 7-point rating scale that provide scores on 3 scales: effectiveness (items #1 #2 #3), convenience (items #4 #5 #6) and global satisfaction (items #7 #8 #9). The TSQM-9 domain scores were calculated as recommended by the instrument authors. (i) Effectiveness = [(item1 + item2 + item3) - 3]/18*100, (ii) Convenience = [(item4 + item5 + item6) - 3]/18*100 and (iii) Global satisfaction = [(item7 + item8 + item9) - 3]/14*100. Each domain score can be calculated only if all the three items considered in the calculation of that score are not missing. The TSQM-9 domain scores range from 0 to 100, with higher scores representing higher satisfaction on that domain. | Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis. | Posted | Mean | Standard Deviation | Unit on Scale | At enrollment visit, 6-month follow-up visit and 12-month follow-up visit. |
From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total COPD Patients | Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 21.0 | Systematic Assessment |
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Neither study was designed to prove the existence clinical factors of any causal relationship nor foreseen a selection method for balanced groups. Neither treatment satisfaction was assessed nor validated to identify patients' satisfaction.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2015 | Sep 13, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2017 | Sep 13, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
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| At enrollment visit, 6-month follow-up visit and 12-month follow-up visit |
| The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | A regression model was estimated, where the dependent variable was the effectiveness domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. | Up to 12 months |
| The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | A regression model was estimated, where the dependent variable was the convenience domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. | Up to 12 months |
| The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | A regression model was estimated, where the dependent variable was the global satisfaction domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values.Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. | Up to 12 months |
| The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period | Health care resources consumption related to COPD, COPD exacerbations and COPD-drug-related adverse events was computed during observational period in terms of number of (inward and day-hospital) hospitalizations, number of emergency room accesses, number of General Practitioner (GP) visits, specialist visits and laboratory tests or examinations. Hospitalization (Number Analyzed) - Number of hospitalizations not in ICU during observation period per patient, Emergency room accesses (Number Analyzed) - Number of Emergency room accesses during observation period per patient, Specialist Outpatient Visits (Number Analyzed) - Number of specialist outpatient visits per patient during observation period, GP Visits (Number Analyzed) - Number of general practitioner visits per patient during observation period, Laboratory Tests (Number Analyzed) - Number of tests per patient during observation period. | Up to 12 months |
| Correlation Between Patients' Satisfaction and Resource Utilization | Correlation indexes were calculated between treatment satisfaction domain scores of TSQM-9 and healthcare resource consumption at 12-month follow-up visit. Hospitalization - Number of hospitalizations not in ICU during observation period per patient, Specialist Outpatient - Number of specialist outpatient visits per patient during observation period, E = Effectiveness at 12 months and C = Convenience at 12 months | 12-month follow-up visit |
| Ancona |
| 60127 |
| Italy |
| Ospedale Reg Umberto Parini | Aosta | 11100 | Italy |
| A. O. Giuseppe Moscati | Avellino | 83100 | Italy |
| Ospedale Civile di Battipaglia | Battipaglia Salerno | 84091 | Italy |
| IRCCS - Istituto Scientifico di Cassano delle Murge | Cassano Murge Bari | 70020 | Italy |
| Azienda Ospedaliera Universitaria Arcispedale Sant'Anna | CONA (FE) | 44124 | Italy |
| Policlinico San Martino | Genova | 16132 | Italy |
| Az. Unità Loc. Socio-Sanitaria 21 - | Legnago | 37045 | Italy |
| Spedali Riuniti di Livorno | Livorno | 57100 | Italy |
| Fondazione Salvatore Maugeri | Milan | 20138 | Italy |
| Asst Santi Paolo E Carlo | Milan | 20142 | Italy |
| Osp. dei Colli Monaldi-Cotugno | Naples | 80131 | Italy |
| Azienda Sanitaria Ospedale S. Luigi Gonzaga | Orbassano | 10043 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello | Palermo | 90146 | Italy |
| Fondazione IRCCS Policlinico S. Matteo | Pavia | 27100 | Italy |
| Azienda Unità Sanitaria Locale di Reggio Emilia | Reggio Emilia | 42123 | Italy |
| Pol. Universitario Tor Vergata | Roma | 00133 | Italy |
| Ospedale Civile Mazzini | Teramo | 64100 | Italy |
| ASL 4 di Terni | Terni | 05100 | Italy |
| Corsico AG, Braido F, Contoli M, Di Marco F, Rogliani P, Scognamillo C, Olivi I, Santus P, Scichilone N, Lazzaro C. Healthcare costs of the SATisfaction and adherence to COPD treatment (SAT) study follow-up. Respir Med. 2019 Jul;153:68-75. doi: 10.1016/j.rmed.2019.05.017. Epub 2019 May 29. |
| 30587957 | Derived | Baiardini I, Rogliani P, Santus P, Corsico AG, Contoli M, Scichilone N, Di Marco F, Lessi P, Scognamillo C, Molinengo G, Ferri F, Patella V, Fiorentino G, Carone M, Braido F. Disease awareness in patients with COPD: measurement and extent. Int J Chron Obstruct Pulmon Dis. 2018 Dec 17;14:1-11. doi: 10.2147/COPD.S179784. eCollection 2019. |
| Physician Decision |
|
| Withdrawal/Loss To Follow-Up |
|
| Withdrawal/ Physician's Decision |
|
| Other than listed |
|
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Number of subjects is categorized as Male or Female. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number of subjects is categorized for race data. Ethnicity was not captured in this trial. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Enrollment Visit | Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients) |
| OG001 | 6-month Follow-up | Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months. |
| OG002 | 12-month Follow-up | Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 12 months. |
|
|
| Secondary | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | Patient's disease perception was evaluated by Brief Illness Perception Questionnaire (B-IPQ) consist 8 questionnaires rated 1 - 10 response scale. Mean total score ranges from 8-80, where a greater score indicated a more threatening view of COPD. Adherence was measured using Morisky Medication Adherence Scale, 4 items (MMAS-4) questionnaire which consists of 4 questions. Items are summed to give an adherence score ranging from 0 to 4, where a higher score indicated a greater adherence grade. Patients' health status was measured using the COPD Assessment Test (CAT) questionnaire that consists of 8-items in which patients can choose a score from 0 to 5. The total score ranges from 0 to 40, where a higher score indicated a worst impact of symptoms on the patient's daily activities. Dyspnea was measured using Modified Medical Research Council Dyspnea Scale (MMRC) with a 0-to-4 grading system. It had 0-to-4 grading system, with higher score indicating a higher level of dyspnea. | FAS | Posted | Mean | Standard Deviation | Unit on Scale | At enrollment visit, 6-month follow-up visit and 12-month follow-up visit |
|
|
|
| Secondary | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | A regression model was estimated, where the dependent variable was the effectiveness domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. | FAS | Posted | Mean | Standard Error | Beta coefficient estimate | Up to 12 months |
|
|
|
|
| Secondary | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | A regression model was estimated, where the dependent variable was the convenience domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. | FAS | Posted | Mean | Standard Error | Beta coefficient estimate | Up to 12 months |
|
|
|
|
| Secondary | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | A regression model was estimated, where the dependent variable was the global satisfaction domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values.Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. | FAS | Posted | Mean | Standard Error | Beta coefficient estimate | Up to 12 months |
|
|
|
|
| Secondary | The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period | Health care resources consumption related to COPD, COPD exacerbations and COPD-drug-related adverse events was computed during observational period in terms of number of (inward and day-hospital) hospitalizations, number of emergency room accesses, number of General Practitioner (GP) visits, specialist visits and laboratory tests or examinations. Hospitalization (Number Analyzed) - Number of hospitalizations not in ICU during observation period per patient, Emergency room accesses (Number Analyzed) - Number of Emergency room accesses during observation period per patient, Specialist Outpatient Visits (Number Analyzed) - Number of specialist outpatient visits per patient during observation period, GP Visits (Number Analyzed) - Number of general practitioner visits per patient during observation period, Laboratory Tests (Number Analyzed) - Number of tests per patient during observation period. | FAS | Posted | Mean | Standard Deviation | Number of events | Up to 12 months |
|
|
|
| Secondary | Correlation Between Patients' Satisfaction and Resource Utilization | Correlation indexes were calculated between treatment satisfaction domain scores of TSQM-9 and healthcare resource consumption at 12-month follow-up visit. Hospitalization - Number of hospitalizations not in ICU during observation period per patient, Specialist Outpatient - Number of specialist outpatient visits per patient during observation period, E = Effectiveness at 12 months and C = Convenience at 12 months | FAS | Posted | Number | Spearman's correlation coefficients | 12-month follow-up visit |
|
|
|
| 9 |
| 401 |
| 12 |
| 401 |
| 0 |
| 401 |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
|
| Death | General disorders | 21.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | 21.0 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
|
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 21.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | 21.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 21.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| MMAS-4 (0-4) |
|
|
| CAT score (0-40) |
|
|
| Patients' dyspnea (MMRC) |
|
|
| Title | Measurements |
|---|---|
|
| Gender (Female vs Male) |
|
| Number of exacerbations in the year before Visit 1 |
|
| FEV1 predicted (%) at enrollment |
|
| MMAS-4 score class at Visit 1 (Score = 2 vs 4) |
|
| MMAS-4 score class at Visit 1 (Score = 3 vs 4) |
|
| CAT score at Visit 1 |
|
| Title | Measurements |
|---|---|
|
| Gender (Female vs Male) |
|
| Number of exacerbations in the year before Visit 1 |
|
| FEV1 predicted (%) at enrollment |
|
| MMAS-4 score class at Visit 1 (Score = 2 vs 4) |
|
| MMAS-4 score class at Visit 1 (Score = 3 vs 4) |
|
| CAT score at Visit 1 |
|
| Title | Measurements |
|---|---|
|
| Gender (Female vs Male) |
|
| Number of exacerbations in the year before Visit 1 |
|
| FEV1 predicted (%) at enrollment |
|
| MMAS-4 score class at Visit 1 (Score = 2 vs 4) |
|
| MMAS-4 score class at Visit 1 (Score = 3 vs 4) |
|
| CAT score at Visit 1 |
|
| Title | Measurements |
|---|---|
|
| GP Visits |
|
| Laboratory Tests |
|
|