Azithromycin a Treatment for Pulmonary Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04020380
• Date of registration: 11/07/2019
• Prospective Registration: Yes
• Primary sponsor: Hull University Teaching Hospitals NHS Trust
• Public title: Azithromycin a Treatment for Pulmonary Sarcoidosis CAPS
• Scientific title: A Single Arm, Open-label Exploratory Clinical Trial of Azithromycin in Pulmonary Sarcoidosis
• Date of first enrolment: September 6, 2019
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04020380
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Simon Hart, MD
• Affiliation: Hull University Teaching Hospitals NHS Trust

Key inclusion & exclusion criteria

Inclusion Criteria:

- • 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 Criteria:

- • 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis, Pulmonary

Intervention(s)

Drug: Azithromycin 250Mg Capsule

Primary Outcome(s)

change in 24 hr cough counts from baseline [Time Frame: 3 months]

Secondary Outcome(s)

Mean Change in severity of cough from baseline [Time Frame: 3 months]

Mean Change in Kings sarcoidosis questionnaire total score from baseline [Time Frame: 3 months]

Mean Change in urge to cough from baseline [Time Frame: 3 months]

Mean Change in Leicester cough questionnaire total score from baseline [Time Frame: 3 months]

Secondary ID(s)

SARC2019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors