Pulmonary Disease, Chronic ObstructiveNCT03543176
Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The main purpose of the study is to assess the burden of illness for, COPD using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, Fluticasone/Salmeterol FLUT/SAL; Advair) or Umeclidinium/Vilanterol (UMEC/VI; Anoro) to support… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- UMEC/VI, FLUT/SAL and CAT
- Type of treatment
- Medical device
- How many people
- 789 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 21 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study will include Medicare Advantage (Medicare) health plan members with evidence of COPD, in the 12 months prior to sample identification and evidence of treatment with UMEC/VI or FLUT/SAL, single-inhaler dual therapy in the six months prior to sample identification. All adults (male and female) subjects with age, greater than or equal to 65 years will be included.
Who may be able to join
- >=2 International Statistical Classification of Diseases and Related Health Problems (ICD)-10-CM diagnosis codes for COPD at least 30 days apart during the 12 month period prior to sample identification.
- Diagnosis codes J40-J44 will be included.
- >=1 pharmacy claim for UMEC/VI or FLUT/SAL single-inhaler dual therapy during Baseline.
- Age >= 65 years.
- Self-reported health care provider diagnosis of COPD.
- Self-reported prescription for FLUT/SAL or UMEC/VI.
- 12 months of continuous enrollment during the Baseline period.
- Ability to complete the study survey in English.
Who cannot join
- >=2 ICD-10-CM diagnosis codes for asthma at least 30 days apart during the, 12 month period, prior to sample identification.
- Claims for both UMEC/VI and FLUT/SAL in the 6 months, closest to sample identification.
- Claims for triple therapy (Inhaled Corticosteroid [ICS] + Long-acting Antimuscarinic [LAMA] + Long-acting Beta-agonist [LABA] during the Baseline period.
- Evidence of lung cancer diagnosis and/or treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Durham, North Carolina, 27709
About this study
Official title: Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy
The main purpose of the study is to assess the burden of illness for, COPD using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, Fluticasone/Salmeterol FLUT/SAL; Advair) or Umeclidinium/Vilanterol (UMEC/VI; Anoro) to support Global Initiative for Chronic Lung Disease (GOLD) category B recommendations. The study will use a health plan recruitment strategy and subject's will be recruited using Optum's health plan recruitment strategy to collect information relating to the subject's condition history, current treatment, smoking history, symptoms and symptom severity (Modified Medical Research Council Dyspnoea Scale [mMRC] and COPD Assessment Test [CAT]), and demographic and sociodemographic characteristics. A total of 2700 subject's, are planned to be enrolled in the study to reach the target evaluable sample size, n=770 subjects. Following completion of data collection, results of the survey, will be merged with claims data, covering the 12-month Baseline period for analysis. Pharmacy and medical claims data, will be used to calculate all-cause and COPD-related health care utilization and costs, treatment patterns, and Baseline clinical characteristics. The study duration is estimated to be of 12-months.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- UMEC/VI, FLUT/SAL, CAT, mMRC, Ellipta
- Keywords
- Cohort, Chronic obstructive pulmonary disease, Observational, GOLD, Claims, Health plan recruitment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMEC/VIOther
UMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta .
FLUT/SALOther
FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.
CATOther
Questionnaire used to asses Condition-related well-being, for COPD subjects.
mMRCOther
Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.
ElliptaDevice
It is a single once daily, Dry powder Inhaler (DPI), developed for delivery of therapies in COPD subjects.
DiskusDevice
It is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects.
| Study group | Role | What they receive |
|---|---|---|
| UMEC/VI | The subjects in this arm had received, UMEC/VI as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual LAMA/LABA therapy, given via Ellipta . Receives: Other: UMEC/VI; Other: CAT; Other: mMRC; Device: Ellipta | |
| FLUT/SAL | The subjects in this arm had received, FLUT/SAL as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy ICS/LABA treatment, given via DISKUS. Receives: Other: FLUT/SAL; Other: CAT; Other: mMRC; Device: Diskus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire
The CAT questionnaire is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact). Respondents were allowed to have up to two missing CAT items. If one or two items were missing, the total score was set to the average of the non-missing item scores. Percentage of participants reporting low, medium, high and very high impact COPD symptom burden on CAT scale has been presented. All enrolled Population comprises of all participants with claims >= 1.
Measured: Day 1
Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale
Breathlessness was assessed using the mMRC, a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 0) to almost complete incapacity (Grade 4). The score (Grade) was the number that best fit the participant's level of activity. The mMRC categorized participants into low dyspnea (Grades 0-1) and high dyspnea (Grades 2-4).
Measured: Day 1
Secondary outcomes (17)
Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics
A comorbidity score was calculated based on the presence of diagnosis codes on medical claims in the Baseline period. The mean score has been presented. the scores was categorized into the following groups: one to two, three to four and five or more.
Measured: 12 months
Mean Count of Unique Medications-Baseline All Cause Utilization
A count of unique medications filled in the 12-month Baseline period was calculated. The mean values has been presented.
Measured: 12 months
Mean Total Number of Medications Dispensing-Baseline All Cause Utilization
A count of unique dispensing's for all medications filled in the 12-month Baseline period was calculated.
Measured: 12 months
Percentage of Participants With All Cause Healthcare Resource Utilization
Binary indicators and counts of ambulatory (physician office and hospital outpatient) visits, emergency department (ED) visits, and inpatient stays were calculated in the 12-month Baseline period. Percentage of participants with inpatient stays, emergency room visits, ambulatory visits, office visits and outpatient visits in Baseline period has been presented.
Measured: 12 months
Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts
Mean number of inpatient admissions during the 12 months Baseline period has been presented.
Measured: 12 months
Length of Stay in Hospital-Baseline All Cause Utilization Counts
Binary indicators and counts of inpatient stays were calculated in the 12-month Baseline period. Length of stay during the 12 months Baseline period has been presented.
Measured: 12 months
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts
Binary indicators and counts of ambulatory (physician office and hospital outpatient) visits and ED visits were calculated in the 12-month Baseline period. Mean number of emergency room, ambulatory, office and outpatient visits during the 12 months Baseline period has been presented.
Measured: 12 months
Mean Total Baseline All Cause Healthcare Costs
Consumer Price Index-adjusted costs were assessed for the 12-month Baseline period. Costs were calculated as total costs, pharmacy costs, and medical costs; medical costs include ambulatory (physician office and hospital outpatient) costs, emergency costs, inpatient costs, and other costs. Mean total all cause healthcare costs that includes medical costs and pharmacy costs during the 12 months Baseline period has been presented.
Measured: 12 months
Mean Count of Unique COPD Medications-Baseline COPD Medication
A count of unique COPD medications filled in the 12-month Baseline period was calculated. The mean values have been presented.
Measured: 12 months
Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications
A count of unique COPD dispensings for all medications filled in the 12-month Baseline period was calculated.
Measured: 12 months
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization
Binary indicators and counts of ambulatory (physician office and hospital outpatient) visits, ED visits, and inpatient stays were calculated in the 12-month Baseline period. Utilization defined was considered COPD-related when a diagnosis code for COPD is in the primary position. Percentage of participants with inpatient stay, emergency room, ambulatory, office and outpatient visits during the 12-months Baseline period has been presented.
Measured: 12 months
Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts
Mean number of Baseline COPD related inpatient admissions during the 12 months Baseline period has been presented.
Measured: 12 months
Length of Inpatient Stay-Baseline COPD Related Utilization Counts
Binary indicators and counts of inpatient stays were calculated in the 12-month Baseline period. Baseline COPD related length of inpatient stay during the 12 months Baseline period has been presented.
Measured: 12 months
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts
Binary indicators and counts of ambulatory (physician office and hospital outpatient) visits and ED visits were calculated in the 12-month Baseline period. Mean number of Baseline COPD related emergency room, ambulatory, office and outpatient visits during the 12 months Baseline period has been presented.
Measured: 12 months
Mean Total Baseline COPD-related Healthcare Costs
Consumer Price Index-adjusted costs were assessed for the 12-month Baseline period. Costs was calculated as total costs, pharmacy costs, and medical costs; medical costs include ambulatory (physician office and hospital outpatient) costs, emergency costs, inpatient costs, and other costs. Costs defined was considered COPD-related if the claim has a diagnosis code for COPD in the primary position or is for a medication used to treat COPD. Mean total Baseline COPD related healthcare costs that includes medical costs and pharmacy costs during the 12 months Baseline period has been presented.
Measured: 12 months
Number of Participants With Atleast One Baseline COPD Exacerbation
Whether the participant has evidence of a COPD exacerbation during the 12-month Baseline period was captured. A moderate COPD exacerbation was defined as either an emergency room visit with the primary diagnosis of COPD and/or an ambulatory visit with the primary diagnosis of COPD. The COPD-related qualifying emergency room or ambulatory event must also have a dispensing of antibiotics or systemic corticosteroids +/- 5 days from the date of service of the emergency room or ambulatory event. A severe COPD exacerbation was defined as a hospitalization with a primary diagnosis code of COPD. The count of participants with atleast one COPD exacerbation has been presented.
Measured: 12 months
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification
The GOLD categories were classified based on CAT and mMRC scores. GOLD A includes participants reporting COPD CAT symptoms score <10 and mMRC as 0-1; GOLD B includes participants reporting CAT symptom score >=10 and mMRC as >=2; GOLD C includes participants reporting exacerbation history as >=2 or >=1 leading to hospitalization; GOLD D includes participants reporting exacerbation history as 0 or 1 and not leading to hospitalization. The number of participants in each GOLD category of symptom burden and exacerbation, was presented. The calculation used was count of COPD exacerbations during the Baseline combined with CAT total score and mMRC score to create mutually exclusive counts for each category.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start31 May 2018
- Primary completion21 Aug 2019
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UnitedHealth Group
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543176
- Sponsor's protocol ID
- 208782
- Status last verified
- Jul 2020
- First submitted
- 18 May 2018
- Last updated
- 5 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Date Request site.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy
- ClinicalTrials.gov ID
- NCT03543176
- Acronym / sponsor ID
- 208782
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Cohort, Chronic obstructive pulmonary disease, Observational, GOLD, Claims, Health plan recruitment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- UnitedHealth Group
- Study start
- 31 May 2018 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Posted 5 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to assess the burden of illness for, COPD using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, Fluticasone/Salmeterol FLUT/SAL; Advair) or Umeclidinium/Vilanterol (UMEC/VI; Anoro) to support Global Initiative for Chronic Lung Disease (GOLD) category B recommendations. The study will use a health plan recruitment strategy and subject's will be recruited using Optum's health plan recruitment strategy to collect information relating to the subject's condition history, current treatment, smoking history, symptoms and symptom severity (Modified Medical Research Council Dyspnoea Scale [mMRC] and COPD Assessment Test [CAT]), and demographic and sociodemographic characteristics. A total of 2700 subject's, are planned to be enrolled in the study to reach the target evaluable sample size, n=770 subjects. Following completion of data collection, results of the survey, will be merged with claims data, covering the 12-month Baseline period for analysis. Pharmacy and medical claims data, will be used to calculate all-cause and COPD-related health care utilization and costs, treatment patterns, and Baseline clinical characteristics. The study duration is estimated to be of 12-months.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UMEC/VI | – | Other: UMEC/VI, Other: CAT, Other: mMRC, Device: ElliptaThe subjects in this arm had received, UMEC/VI as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual LAMA/LABA therapy, given via Ellipta . |
| FLUT/SAL | – | Other: FLUT/SAL, Other: CAT, Other: mMRC, Device: DiskusThe subjects in this arm had received, FLUT/SAL as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy ICS/LABA treatment, given via DISKUS. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study will include Medicare Advantage (Medicare) health plan members with evidence of COPD, in the 12 months prior to sample identification and evidence of treatment with UMEC/VI or FLUT/SAL, single-inhaler dual therapy in the six months prior to sample identification. All adults (male and female) subjects with age, greater than or equal to 65 years will be included.
Key inclusion criteria (8 listed)
- >=2 International Statistical Classification of Diseases and Related Health Problems (ICD)-10-CM diagnosis codes for COPD at least 30 days apart during the 12 month period prior to sample identification.
- Diagnosis codes J40-J44 will be included.
- >=1 pharmacy claim for UMEC/VI or FLUT/SAL single-inhaler dual therapy during Baseline.
- Age >= 65 years.
- Self-reported health care provider diagnosis of COPD.
Key exclusion criteria (4 listed)
- >=2 ICD-10-CM diagnosis codes for asthma at least 30 days apart during the, 12 month period, prior to sample identification.
- Claims for both UMEC/VI and FLUT/SAL in the 6 months, closest to sample identification.
- Claims for triple therapy (Inhaled Corticosteroid [ICS] + Long-acting Antimuscarinic [LAMA] + Long-acting Beta-agonist [LABA] during the Baseline period.
- Evidence of lung cancer diagnosis and/or treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UMEC/VIUMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta . | Other | UMEC/VI |
| FLUT/SALFLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus. | Other | FLUT/SAL |
| CATQuestionnaire used to asses Condition-related well-being, for COPD subjects. | Other | FLUT/SAL, UMEC/VI |
| mMRCQuestionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects. | Other | FLUT/SAL, UMEC/VI |
| ElliptaIt is a single once daily, Dry powder Inhaler (DPI), developed for delivery of therapies in COPD subjects. | Device | UMEC/VI |
| DiskusIt is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects. | Device | FLUT/SAL |
Primary outcome
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire
Time frame: Day 1
The CAT questionnaire is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact). Respondents were allowed to have up to two missing CAT items. If one or two items were missing, the total score was set to the average of the non-missing item scores. Percentage of participants reporting low, medium, high and very high impact COPD symptom burden on CAT scale has been presented. All enrolled Population comprises of all participants with claims >= 1.
Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Day 1
Breathlessness was assessed using the mMRC, a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 0) to almost complete incapacity (Grade 4). The score (Grade) was the number that best fit the participant's level of activity. The mMRC categorized participants into low dyspnea (Grades 0-1) and high dyspnea (Grades 2-4).
17 secondary outcomes
Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics
Time frame: 12 months
Mean Count of Unique Medications-Baseline All Cause Utilization
Time frame: 12 months
Mean Total Number of Medications Dispensing-Baseline All Cause Utilization
Time frame: 12 months
Percentage of Participants With All Cause Healthcare Resource Utilization
Time frame: 12 months
Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts
Time frame: 12 months
Length of Stay in Hospital-Baseline All Cause Utilization Counts
Time frame: 12 months
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts
Time frame: 12 months
Mean Total Baseline All Cause Healthcare Costs
Time frame: 12 months
Mean Count of Unique COPD Medications-Baseline COPD Medication
Time frame: 12 months
Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications
Time frame: 12 months
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization
Time frame: 12 months
Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts
Time frame: 12 months
Length of Inpatient Stay-Baseline COPD Related Utilization Counts
Time frame: 12 months
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts
Time frame: 12 months
Mean Total Baseline COPD-related Healthcare Costs
Time frame: 12 months
Number of Participants With Atleast One Baseline COPD Exacerbation
Time frame: 12 months
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Date Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.