Status:
COMPLETED
Azithromycin a Treatment for Pulmonary Sarcoidosis
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Conditions:
Sarcoidosis, Pulmonary
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Patients with sarcoidosis need treatment options that effectively control their disease without causing undesirable side effects. An appealing strategy is to repurpose existing drugs which possess ben...
Detailed Description
Disease behavior in sarcoidosis is variable and difficult to predict. Spontaneous improvement may occur, but even then evidence of persistent low grade granulomatous inflammation is common and disabli...
Eligibility Criteria
Inclusion
- • Males or females, of any race, between 18 and 80 years of age, inclusive;
- Able to speak, read, and understand English;
- Able to provide written informed consent;
- Able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions.
- Clinician diagnosis of pulmonary sarcoidosis;
- If a female of child-bearing potential (i.e., have not undergone a hysterectomy or bilateral oophorectomy) or not post-menopausal (defined as no menses for at least 12 months), agree to use acceptable birth control (defined in Section 6.3) from screening through to the follow up visit;
Exclusion
- • Hypersensitivity to azithromycin or another macrolide antibiotic (e.g. erythromycin, clarithromycin) or excipients (see 7.4)
- History of signficant cardiac arrhythmia
- Personal or family history of congenital long QT syndrome;
- Prolonged QTc interval on 12-lead ECG
- Signficant liver disease
- Evidence of acute bacterial infection
- Clinically significant bronchiectasis
- Requiring concomitant therapy with prohibited medications (see Section 7.5)
- Pregnant or breastfeeding;
- Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion;
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial.
Key Trial Info
Start Date :
September 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04020380
Start Date
September 6 2019
End Date
June 20 2020
Last Update
July 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Respiratory Medicine Clinical trials Unit
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ