AsthmaResalaNCT04550780
Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab
An observational study of Asthma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Currently, no study has addressed real-life data describing changes in health resource consumption and related costs attributable to mepolizumab treatment. The aim of the current study is to fill this knowledge gap by performing an exhaustive extraction of data for patients receiving mepolizumab in the French… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Mepolizumab
- How many people
- 7,938 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2021to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will comport all beneficiaries in the national French SNDS database who were prescribed mepolizumab and for whom health resource use data is available for the 12 months preceding and following a first filled prescription for mepolizumab.
Who may be able to join
- Beneficiary in the anonymous French national SNDS database
- The beneficiary received mepolizumab
Who cannot join
- Health resource use data covering the 12 months preceding the first filled prescription for mepolizumab are not available
- Health resource use data covering the time period starting at the first filled prescription for mepolizumab and ending at subsequent death or at 12 months later are not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab (Nucala): a French SNDS Database Study
Currently, no study has addressed real-life data describing changes in health resource consumption and related costs attributable to mepolizumab treatment. The aim of the current study is to fill this knowledge gap by performing an exhaustive extraction of data for patients receiving mepolizumab in the French single-payer health care system. The change in real-life health-resource usage and costs observed for these patients would provide the first evidence that mepolizumab is changing the care landscape for eligible severe asthma patients.
The overall objectives of this study are: (i) using the SNDS French national database, to identify a representative, nation-wide population of patients treated with mepolizumab with a follow-up period of at least 12 months, (ii) to describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment and (iii) to estimate the change in associated costs for the first year of treatment. These initial data will additionally serve as a basis for the design of longer-term studies.
Primary objective: To estimate the change in associated costs for the first year of treatment
Read the detailed description
Secondary objectives:
- To describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment
- To further characterize rates of change in health resource usage and/or costs in subpopulations of interest (sex, age groups, severe asthma, uncontrolled asthma, COPD, diabetes)
This retrospective, non-interventional (not involving human subjects) database study will compare real-life patient health resource consumption before versus after a first injection of mepolizumab. Data concerning patients receiving mepolizumab will be collated for a 12-month period (the "baseline period") preceding a first index treatment (at "T0") and compared to a 12-month period occurring after the index treatment (the "exposure period").
- Conditions
- Asthma
- Being tested
- Mepolizumab
- Keywords
- Mepolizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
The first administration of mepolizumab.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The study population will comport all beneficiaries in the national French SNDS database who were prescribed mepolizumab and for whom health resource use data is available for the 12 months preceding and following a first filled prescription for mepolizumab. Receives: Drug: Mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in total health care costs for the year preceding the initiation of mepolizumab versus for the year after.
Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods.
Day 0 = the initiation of mepolizumab treatment.
Measured: -12 months versus +12 months
Secondary outcomes (21)
Change in drug consumption: mepolizumab
Drug consumption refers to the quantity of medication consumed.
Measured: -12 months versus +12 months
Change in drug consumption: corticosteroids
Drug consumption refers to the quantity of medication consumed.
Measured: -12 months versus +12 months
Change in drug consumption: asthma-specific medications
Drug consumption refers to the quantity of medication consumed.
Measured: -12 months versus +12 months
Change in drug consumption: diabetes-related medications
Drug consumption refers to the quantity of medication consumed.
Measured: -12 months versus +12 months
Change in the number of hospitalisations: all causes
Measured: -12 months versus +12 months
Change in the number of hospitalisations: asthma-related
Measured: -12 months versus +12 months
Change in the cumulative number of days of hospitalisation: all causes
Measured: -12 months versus +12 months
Change in the cumulative number of days of hospitalisation: asthma-related
Measured: -12 months versus +12 months
Change in the cumulative number of days of intensive care: all causes
Measured: -12 months versus +12 months
Change in the cumulative number of days of intensive care: asthma-related
Measured: -12 months versus +12 months
Change in the number of generalist consults
The cumulative numbers of consultations will be compared between the baseline and exposure period and differentiated according to type (general and specialist medical consults, nursing and other paramedical consults etc). Special attention will be given to pulmonology/allergology and metabolic/endocrine specialist consults, as well as nursing consults for injections.
Measured: -12 months versus +12 months
Change in the number of specialist consults
The cumulative numbers of consultations will be compared between the baseline and exposure period and differentiated according to type (general and specialist medical consults, nursing and other paramedical consults etc). Special attention will be given to pulmonology/allergology and metabolic/endocrine specialist consults, as well as nursing consults for injections.
Measured: -12 months versus +12 months
Change in the number of nursing consults
The cumulative numbers of consultations will be compared between the baseline and exposure period and differentiated according to type (general and specialist medical consults, nursing and other paramedical consults etc). Special attention will be given to pulmonology/allergology and metabolic/endocrine specialist consults, as well as nursing consults for injections.
Measured: -12 months versus +12 months
Change in the number of other paramedical consults
The cumulative numbers of consultations will be compared between the baseline and exposure period and differentiated according to type (general and specialist medical consults, nursing and other paramedical consults etc). Special attention will be given to pulmonology/allergology and metabolic/endocrine specialist consults, as well as nursing consults for injections.
Measured: -12 months versus +12 months
Change in the number of lung function assessments
Information concerning the laboratory and imaging assessments performed is available, but not their results. Special attention will be given to lung function, adrenal function, glycemia, and bone density assessments. The cumulative numbers of different assessments will be described and contrasted between the baseline and exposure periods.
Measured: -12 months versus +12 months
Change in the number of adrenal function assessments
Information concerning the laboratory and imaging assessments performed is available, but not their results. Special attention will be given to lung function, adrenal function, glycemia, and bone density assessments. The cumulative numbers of different assessments will be described and contrasted between the baseline and exposure periods.
Measured: -12 months versus +12 months
Change in the number of glycemia assessments
Information concerning the laboratory and imaging assessments performed is available, but not their results. Special attention will be given to lung function, adrenal function, glycemia, and bone density assessments. The cumulative numbers of different assessments will be described and contrasted between the baseline and exposure periods.
Measured: -12 months versus +12 months
Change in the number of bone density assessments
Information concerning the laboratory and imaging assessments performed is available, but not their results. Special attention will be given to lung function, adrenal function, glycemia, and bone density assessments. The cumulative numbers of different assessments will be described and contrasted between the baseline and exposure periods.
Measured: -12 months versus +12 months
The change in health care costs: mepolizumab
Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods. This will be performed at several levels: (i) all costs regardless of source or potential link with diagnoses, (ii) costs due to mepolizumab, (iii) costs that can be associated with asthma-specific care, (iv) costs that can be associated with the monitoring and care for certain key comorbidities (diabetes, bone density/osteoporosis).
Measured: -12 months versus +12 months
The change in health care costs: asthma-specific care
Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods. This will be performed at several levels: (i) all costs regardless of source or potential link with diagnoses, (ii) costs due to mepolizumab, (iii) costs that can be associated with asthma-specific care, (iv) costs that can be associated with the monitoring and care for certain key comorbidities (diabetes, bone density/osteoporosis).
Measured: -12 months versus +12 months
The change in health care costs: comorbidity care
Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods. This will be performed at several levels: (i) all costs regardless of source or potential link with diagnoses, (ii) costs due to mepolizumab, (iii) costs that can be associated with asthma-specific care, (iv) costs that can be associated with the monitoring and care for certain key comorbidities (diabetes, bone density/osteoporosis).
Measured: -12 months versus +12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start3 Dec 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 7,938 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Molinari, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550780
- Sponsor's protocol ID
- RECHMPL20_0393
- Acronym
- Resala
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: SNDS data are accessible only by specially trained and qualified individuals. Due to regulatory constraints, they cannot be made available to the public.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab (Nucala): a French SNDS Database Study
- ClinicalTrials.gov ID
- NCT04550780
- Acronym / sponsor ID
- Resala / RECHMPL20_0393
- Conditions
- Asthma
- Keywords
- Mepolizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,938 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, no study has addressed real-life data describing changes in health resource consumption and related costs attributable to mepolizumab treatment. The aim of the current study is to fill this knowledge gap by performing an exhaustive extraction of data for patients receiving mepolizumab in the French single-payer health care system. The change in real-life health-resource usage and costs observed for these patients would provide the first evidence that mepolizumab is changing the care landscape for eligible severe asthma patients.
The overall objectives of this study are: (i) using the SNDS French national database, to identify a representative, nation-wide population of patients treated with mepolizumab with a follow-up period of at least 12 months, (ii) to describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment and (iii) to estimate the change in associated costs for the first year of treatment. These initial data will additionally serve as a basis for the design of longer-term studies.
Primary objective: To estimate the change in associated costs for the first year of treatment
Detailed description
Secondary objectives:
- To describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment
- To further characterize rates of change in health resource usage and/or costs in subpopulations of interest (sex, age groups, severe asthma, uncontrolled asthma, COPD, diabetes)
This retrospective, non-interventional (not involving human subjects) database study will compare real-life patient health resource consumption before versus after a first injection of mepolizumab. Data concerning patients receiving mepolizumab will be collated for a 12-month period (the "baseline period") preceding a first index treatment (at "T0") and compared to a 12-month period occurring after the index treatment (the "exposure period").
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Drug: MepolizumabThe study population will comport all beneficiaries in the national French SNDS database who were prescribed mepolizumab and for whom health resource use data is available for the 12 months preceding and following a first filled prescription for mepolizumab. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comport all beneficiaries in the national French SNDS database who were prescribed mepolizumab and for whom health resource use data is available for the 12 months preceding and following a first filled prescription for mepolizumab.
Key inclusion criteria (2 listed)
- Beneficiary in the anonymous French national SNDS database
- The beneficiary received mepolizumab
Key exclusion criteria (2 listed)
- Health resource use data covering the 12 months preceding the first filled prescription for mepolizumab are not available
- Health resource use data covering the time period starting at the first filled prescription for mepolizumab and ending at subsequent death or at 12 months later are not available
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 |
|---|---|---|
| MepolizumabThe first administration of mepolizumab. | Drug | The study population |
Primary outcome
The change in total health care costs for the year preceding the initiation of mepolizumab versus for the year after.
Time frame: -12 months versus +12 months
Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods. Day 0 = the initiation of mepolizumab treatment.
21 secondary outcomes
Change in drug consumption: mepolizumab
Time frame: -12 months versus +12 months
Change in drug consumption: corticosteroids
Time frame: -12 months versus +12 months
Change in drug consumption: asthma-specific medications
Time frame: -12 months versus +12 months
Change in drug consumption: diabetes-related medications
Time frame: -12 months versus +12 months
Change in the number of hospitalisations: all causes
Time frame: -12 months versus +12 months
Change in the number of hospitalisations: asthma-related
Time frame: -12 months versus +12 months
Change in the cumulative number of days of hospitalisation: all causes
Time frame: -12 months versus +12 months
Change in the cumulative number of days of hospitalisation: asthma-related
Time frame: -12 months versus +12 months
Change in the cumulative number of days of intensive care: all causes
Time frame: -12 months versus +12 months
Change in the cumulative number of days of intensive care: asthma-related
Time frame: -12 months versus +12 months
Change in the number of generalist consults
Time frame: -12 months versus +12 months
Change in the number of specialist consults
Time frame: -12 months versus +12 months
Change in the number of nursing consults
Time frame: -12 months versus +12 months
Change in the number of other paramedical consults
Time frame: -12 months versus +12 months
Change in the number of lung function assessments
Time frame: -12 months versus +12 months
Change in the number of adrenal function assessments
Time frame: -12 months versus +12 months
Change in the number of glycemia assessments
Time frame: -12 months versus +12 months
Change in the number of bone density assessments
Time frame: -12 months versus +12 months
The change in health care costs: mepolizumab
Time frame: -12 months versus +12 months
The change in health care costs: asthma-specific care
Time frame: -12 months versus +12 months
The change in health care costs: comorbidity care
Time frame: -12 months versus +12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Resala on the Open Science FrameworkLink provided by the sponsor.
- Individual participant dataSharing planned: No. SNDS data are accessible only by specially trained and qualified individuals. Due to regulatory constraints, they cannot be made available to the public.
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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.
Nicolas Molinari, PhD study director
University Hospital, Montpellier
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 Asthma, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 2 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 23 Oct 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in total health care costs for the year preceding the initiation of mepolizumab versus for the year after. (time frame: -12 months versus +12 months). 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 23 Oct 2023.