Chronic pulmonary aspergillosis
Conditions
Brief summary
Therapeutic efficacy at 6 months is a composite criterion defined by the association of clinical improvement/stability and radiological improvement.
Detailed description
-Clinical evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or clinical deterioration./-Radiological evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or deterioration, -Major events during the 24-months follow-up period after stopping study treatment (i.e.; between visit M6 (at 6 months) and visit M30 (at 30 months)., Relapse during the 24-months follow-up period after stopping study treatment (between visits M6 and M30)., Mycological response after 3 and 6 months of study treatment., Number of medical consultations or hospitalizations for respiratory symptoms during the 6-month study treatment and the 24-month follow-up period, Clinical and biological tolerance, Improvement in quality of life evaluated by the VQ-11 Questionnaire, Concordance evaluation assessment between parameters for CPA diagnosis and evolution (see ancillary project annex 3 of this protocol)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic efficacy at 6 months is a composite criterion defined by the association of clinical improvement/stability and radiological improvement. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Clinical evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or clinical deterioration./-Radiological evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or deterioration, -Major events during the 24-months follow-up period after stopping study treatment (i.e.; between visit M6 (at 6 months) and visit M30 (at 30 months)., Relapse during the 24-months follow-up period after stopping study treatment (between visits M6 and M30)., Mycological response after 3 and 6 months of study treatment., Number of medical consultations or hospitalizations for respiratory symptoms during the 6-month study treatment and the 24-month follow-up period, Clinical and biological tolerance, Improvement in quality of life evaluated by the VQ-11 Questionnaire, Concordance evaluation assessment between parameters for CPA diagnosis and evolution (see ancillary project annex 3 of this protocol) | — |
Countries
France