EUCTR2017-004219-37-DE
Active, not recruiting
Phase 1
A randomized, prospective, multicenter, controlled and double-blinded Phase II Clinical Trial to evaluate the influence of inhaled Aviptadil on Cough and Quality of Life in Sarcoidosis patients - Avisarco II
niversitätsklinikum Freiburg, Leitender Ärztlicher Direktor0 sites200 target enrollmentJuly 29, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitätsklinikum Freiburg, Leitender Ärztlicher Direktor
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adult male and female patients \= 18 years of age
- •2\.Patient with sarcoidosis and associated chronic cough (LCQ score \< 16\), any Scadding type, any other organ manifestation as long as it does not require prednisolone therapy \> 15 mg, see exclusion criteria 3\)
- •3\.Body mass index (BMI) \<30 kg/m2
- •4\.Patients supposed to be kept on stable medication for the whole study period
- •5\.Written informed consent obtained according to international guidelines and local laws
- •6\.Negative results for HIV, hepatitis A, B and C within three months prior to study inclusion
- •7\.Ability to understand the nature of the trial and the trial related procedures in German and to comply with them
- •8\.Ability to use the nebulizer in a proper manner
- •9\.Ability to store the IMP according to requirements
- •Are the trial subjects under 18? no
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 4
A prospective, multicenter, randomized, controlled study to evaluate the clinical outcome of Zhenyuan capsule in the treatment of heart failure after myocardial infarctioHeart failure after myocardial infarctionITMCTR2200005706Zhongshan Hospital affiliated to Fudan University
Active, not recruiting
Not Applicable
A multicenter, randomized, prospective, controlled study to evaluate the efficacy and the tolerability of a switch to a two different-dosed, nevirapine-based HAARTs in HIV-1 infected patients with undetectable plasma viremia. - SNODOEUCTR2006-002582-39-ITFONDAZIONE NADIR ONLUS200
Active, not recruiting
Not Applicable
Multiple-center clinical trial comparing surgical and conservative treatment in patients with anterior temporomandibular disc displacement without reductioAnterior disc displacement of the temporomandibular joint without reductionMusculoskeletal DiseasesISRCTN99353996West China Medical Center of Sichuan University90
Not yet recruiting
Not Applicable
Evaluation of the Artificial Intelligence Smart Endo” for the Detection of Adenoma in Patients Undergoing ColonoscopyNot ApplicableKCT0005619Gachon University Gil Medical Center1,098
Not yet recruiting
Phase 4
A multi-center clinical study of integrated Traditional Chinese and Western medicine in the management of atherosclerotic cardiovascular diseaseITMCTR2000003930Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM