Pulmonary sarcoidosis associated with cough MedDRA version: 20.0 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Aviptadil
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Aviptadil
CAS Number: 40077-57-4
Current Sponsor code: 4033410
Other descriptive name: AVIPTADIL
Concentration unit
Sponsors
Universitätsklinikum Freiburg, Leitender Ärztlicher Direktor
Universitätsklinikum Freiburg, Kaufmännische Direktorin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male and female patients = 18 years of age 2. Patient with sarcoidosis and associated chronic cough (LCQ score 15 mg, see exclusion criteria 3) 3. Body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Patients suffering from other organic causes of cough (e.g. respiratory tract infections, gastroesophageal reflux disease, heart failure, bronchitis associated with any other disorder but sarcoidosis, thoracic tumors, exposure to inhalable irritants, laryngitis etc) 2. Patients treated with ACE-inhibitors or a history of ACE-inhibitor treatment within the last six weeks (ACE-inhibitors are also not allowed to start during the study) 3. Corticosteroids doses > 15 mg prednisolone equivalent per day 4. Immunosuppressive treatment (except for corticosteroids = 15 mg prednisolone equivalent per day) within 3 months prior randomisation or indications to start or intensify immunosuppressive therapy during the study 5. Patients suffering from other chronic or acute severe diseases besides sarcoidosis manifestations that might impair safe participation in the trial according to the treating physician, e.g.: - Chronic kidney disease (CKD) stage 4 and 5 - Liver cirrhosis Child-Pugh score B and C - Intended surgery of heart, lung, liver or abdominal disease during the trial period - Active malignancies requiring chemo- and / or radiotherapy - Chronic bowel diseases not sufficiently controlled 6. Conditions or medications supposed to influence the primary or secondary outcomes according to the local investigator’s appraisal (e.g. newly diagnosed obstructive sleep apnoea syndrome, newly or recently exacerbated psychiatric disease, modification of psychotic disease) 7. Known HIV infection, infectious hepatitis (type A, B or C) or another currently uncontrolled infection 8. Known hypersensitivity to the active substance or any of the excipients 9. Participation in any other interventional clinical trial during this study or during the last 30 days prior to informed consent; simultaneous participation in registry and diagnostic trials is allowed 10. Previous participation in this trial 11. Known persistent abuse of medication, drugs or alcohol 12. Relationship of dependence/employment with the sponsor or the investigator 13. Current or planned pregnancy, nursing period or patients of reproductive potential who are not using effective birth control methods 14. Male subjects with reproductive potential who refuse to use adequate means of contraception during and up to 90 days after stopping treatment with Aviptadil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of Aviptadil in comparison to placebo on cough-specific QOL ;Secondary Objective: -To assess efficacy of Aviptadil in comparison to placebo on cough-specific QoL -To assess efficacy of Aviptadil in comparison to placebo on sarcoidosis specific QoL, on fatigue, on dyspnea on exertion, on patient’s assessment of cough intensity, on parameters of lung function.;Primary end point(s): Change in LCQ score from baseline until 24 weeks after randomisation ;Timepoint(s) of evaluation of this end point: 24 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: -week 12 after randomisation -week 12 and 24 after randomisation;Secondary end point(s): - Change in LCQ score from baseline until 12 weeks after randomisation -Change in KSQ score from baseline to 12 and 24 weeks after randomisation - Fatigue assessment scale (FAS) week 12 and 24 -Multidimensional fatigue inventory (MFI) week 12 and 24 -Epworth Sleepiness Scale (ESS) week 12 and 24 -Distance-saturation-product (DSP) week 12 and 24 -VAS for cough week 12 and 24 -Lung function parameters at 12 and 24 weeks after randomisation -Cumulative steroid dose up to 24 weeks -6-minute walking distance and distance saturation product at 12 and 24 weeks | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Universitätsklinikum Freiburg
Outcome results
None listed