Last updated: 07/29/2020 12:10:20
Observational and retrospective study to collect long term follow-up real life data from the first patients treated by Nucala in France in the context of nATU
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Observational and retrospective study to collect long term follow-up real life data from the first patients treated by Nucala in France in the context of nATU
Trial description: This is retrospective, observational and epidemiologic study, based on the data from the hospital medical records of subjects who started mepolizumab treatment in the context of the nATU between 09-June-2015 and 02-March-2016. Mepolizumab was available in France through nATU and was delivered between 09-June-2015 and 02-March-2016 for treatment of severe eosinophilic asthma. The data was collected for the France national agency for drug safety (ANSM) and GlaxoSmithKline (GSK). There was report nATU report from April 2016. However, all records as requested by temporary use protocol (PUT) were not collected for all subjects. Hence, this study aims to collect all the follow up data up to 2 years after the treatment initiation with mepolizumab. There will be participating centers which will have at least 1 subject in the nATU and they accept to participate in the study. The treatment access medical records and the follow-up medical records will be filled in by a clinical research assistant (CRA) of the study manager in the participating centers.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Duration of asthma in years
Timeframe: Day 1
Number of subjects with smoking history
Timeframe: Day 1
Number of subjects by geographic location
Timeframe: Day 1
Number of subjects with comorbidities
Timeframe: Day 1
Number of subjects working
Timeframe: Day 1
Number of subjects with asthma induced invalidity
Timeframe: Day 1
Number of subjects by different socio-economic status
Timeframe: Day 1
Number of subjects with complementary health insurance
Timeframe: Day 1
Number of subjects hospitalized due to asthma
Timeframe: Day 1
Number of subjects with atopic history
Timeframe: Day 1
Immunoglobulin E (IgE) level in blood
Timeframe: Day 1
Neutrophil level in blood
Timeframe: Day 1
Number of subjects on oral corticosteroid during blood eosinophil count
Timeframe: Day 1
Number of subjects with adherence to previous treatment estimated by investigators
Timeframe: Day 1
Ratio of forced expiratory volume during first second (FEV1) and forced vital capacity (FVC)
Timeframe: Day 1
Secondary outcomes:
Number of visits of subjects
Timeframe: Up to 2 Years
Number of subjects on oral corticosteroid therapy
Timeframe: Up to 2 Years
Percentage of predicated FEV1 value
Timeframe: Up to 2 Years
Number of subjects with asthma symptoms
Timeframe: Up to 2 Years
Impact of asthma on daily life
Timeframe: Up to 2 Years
Asthma control test (ACT) score
Timeframe: Up to 2 Years
Number of subjects with abnormal blood eosinophil count
Timeframe: Up to 2 Years
Treatment associated to asthma
Timeframe: Up to 2 Years
Number of subjects on mepolizumab treatment
Timeframe: Up to 2 Years
Number of subjects with on treatment adverse events
Timeframe: Up to 2 Years
Number of responders in anti-mepolizumab antibody research
Timeframe: Up to 2 Years
Number of pregnant subjects
Timeframe: Up to 2 Years
Number of subjects who received oral corticosteroid therapy
Timeframe: Up to 2 Years
Number of subjects with emergency unit visit
Timeframe: Up to 2 Years
Number of subjects hospitalized
Timeframe: Up to 2 Years
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2018-30-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Taillé C, Chanez P, Devouassoux G, Didier A, Pison C, Garcia G, Charriot J, Bouée S, Gruber A, Pribil C, Bourdin A, Humbert M.Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme.Eur Respir J.2020;
DOI: 10.1183/13993003.02345-2019
Medical condition
Asthma
Product
mepolizumab
Collaborators
Cemka-Eval
Study date(s)
June 2018 to November 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- Subjects included in the mepolizumab nATU. These subjects received mepolizumab within the program, validated by ANSM, based on data described in the treatment access forms by their physicians who requested the treatment to ANSM. The treatment access forms contained information on blood eosinophils count, exacerbations rate, symptoms control, oral corticosteroids dose, which justified the request and the consequent validation by ANSM. There was no strict eligibility criteria described to allow the request validation.
- Subjects with no objection to record their personal data for this retrospective study
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects included in the mepolizumab nATU. These subjects received mepolizumab within the program, validated by ANSM, based on data described in the treatment access forms by their physicians who requested the treatment to ANSM. The treatment access forms contained information on blood eosinophils count, exacerbations rate, symptoms control, oral corticosteroids dose, which justified the request and the consequent validation by ANSM. There was no strict eligibility criteria described to allow the request validation.
- Subjects with no objection to record their personal data for this retrospective study
Exclusion criteria:
- Not applicable
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2018-30-11
Actual study completion date
2018-30-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
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