Influence of Inhaled Aviptadil on Cough and Quality of life in Sarcoidosis

Phase 1

• Conditions: Pulmonary sarcoidosis associated with cough; MedDRA version: 20.0Level: PTClassification code 10037430Term: Pulmonary sarcoidosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-004219-37-DE
• Lead Sponsor: niversitätsklinikum Freiburg, Leitender Ärztlicher Direktor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-29
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified