Clinical trial • Phase IV • Respiratory

Azithromycin for Sarcoidosis

Phase IV trial of Azithromycin for Sarcoidosis. Placebo (no dose or schedule specified)-controlled. 40 participants.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Sarcoidosis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-04-2024
First CTIS Authorization Date
13-05-2024

Trial design

Placebo (no dose or schedule specified)-controlled Phase IV trial in Netherlands.

Comparator
Placebo (no dose or schedule specified)
Target Sample Size
40

Eligibility

Recruits 40 No vulnerable population selected; consent or assent handling not specified in the record..

Pregnancy Exclusion
- Being pregnant or breastfeeding at time of inclusion
Vulnerable Population
No vulnerable population selected; consent or assent handling not specified in the record.

Inclusion criteria

  • {"criterion_text":"- Biopsy proven sarcoidosis."}
  • {"criterion_text":"- Inflammatory activity according to FDG-PET scan at baseline"}
  • {"criterion_text":"- SUVmax above 3 in the lung and/or above 5 in mediastinum/hili"}
  • {"criterion_text":"- No treatment indication for the sarcoidosis"}

Exclusion criteria

  • {"criterion_text":"- Increased duration of QT interval (>440ms for men and >450ms for women) on ECG"}
  • {"criterion_text":"- Hearing deficits, a possible side-effect of azithromycin use is hearing deficits, although the chance of this is very small"}
  • {"criterion_text":"- Being pregnant or breastfeeding at time of inclusion"}
  • {"criterion_text":"- Use of an investigational drug during the time between FDG-PET scan and screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Reduction of sarcoidosis related inflammation.","definition_or_measurement_approach":"Reduction of inflammatory activity defined by SUVmax on FDG-PET scan (as described in main objective)"}

Recruitment

Planned Sample Size
40
Recruitment Window Months
41
Consent Approach
Not specified in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Netherlands

Earliest CTIS Part Ii Submission Date
01-05-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
12
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
pulmonology
Principal Investigator Name
Montse Janssen Bonas
Principal Investigator Email
m.janssenbonas@antoniusziekenhuis.nl
Contact Person Name
Montse Janssen Bonas
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Sint Antonius Ziekenhuis Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Azithran 500 mg επικαλυμμένα με λεπτό υμένιο δισκία
Active Substance
Azithromycin
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation number 22260, CY)
Maximum Dose
500 mg (max total 1500 mg)
Investigational Product Name
DOXICLAT 100 mg comprimidos recubiertos con película
Active Substance
Doxycycline
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation number 50.404, ES)
Maximum Dose
100 mg (max total 100 mg)
Combination Treatment
Yes

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