Chronic pulmonary aspergillosis (CPA)
Conditions
Brief summary
[Clinical 1:] St George’s Respiratory Questionnaire - a patient reported outcome questionnaire (improvement, stable or deterioration of QoL), [Clinical 2:] Weight (weight gain / loss), [Radiological:] CT thoracic scan to assess radiological improvement (CT changes assessed by independent radiologists experienced in diagnosis of CPA)
Detailed description
Change in Aspergillus IgG levels, weight, St George’s Respiratory questionnaire score, Respiratory Symptom score and EQ-5D-5L score at 3 and 6 months from baseline, Need for a change in antibiotic or steroid prescription, Absence of persistently positive respiratory sample for Aspergillus spp., Change in frequency of echinocandin resistant isolates, Hospitalisations attributed to deterioration in any category, Safety and tolerability of up to 6 months’ treatment assessed by nature and severity of AEs and SAEs, physical examinations and laboratory tests at 3 and 6 months
Interventions
Sponsors
Mundipharma Research Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Clinical 1:] St George’s Respiratory Questionnaire - a patient reported outcome questionnaire (improvement, stable or deterioration of QoL), [Clinical 2:] Weight (weight gain / loss), [Radiological:] CT thoracic scan to assess radiological improvement (CT changes assessed by independent radiologists experienced in diagnosis of CPA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Aspergillus IgG levels, weight, St George’s Respiratory questionnaire score, Respiratory Symptom score and EQ-5D-5L score at 3 and 6 months from baseline, Need for a change in antibiotic or steroid prescription, Absence of persistently positive respiratory sample for Aspergillus spp., Change in frequency of echinocandin resistant isolates, Hospitalisations attributed to deterioration in any category, Safety and tolerability of up to 6 months’ treatment assessed by nature and severity of AEs and SAEs, physical examinations and laboratory tests at 3 and 6 months | — |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Spain
Outcome results
None listed