NCT04020380 (CAPS) is a Phase 2 clinical trial of Azithromycin 250Mg Capsule in Sarcoidosis, Pulmonary, sponsored by Hull University Teaching Hospitals NHS Trust.

Who is sponsoring NCT04020380?

NCT04020380 is sponsored by Hull University Teaching Hospitals NHS Trust.

What drugs are being tested in NCT04020380?

Interventions in NCT04020380: Azithromycin 250Mg Capsule.

What condition does NCT04020380 study?

NCT04020380 studies Sarcoidosis, Pulmonary.

Is NCT04020380 still recruiting?

NCT04020380 is currently completed. Last updated 16 July 2020.

Last reviewed 2020-07-16 · How we verify

NCT04020380: CAPS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Azithromycin a Treatment for Pulmonary Sarcoidosis

Completed Phase 2 Last updated 16 July 2020

What this trial tests

Phase 2 trial testing Azithromycin 250Mg Capsule in Sarcoidosis, Pulmonary in 21 participants. Completed in 20 June 2020.

Timeline

6 September 2019

Primary endpoint
20 June 2020

20 June 2020

Quick facts

Lead sponsor	Hull University Teaching Hospitals NHS Trust
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	6 September 2019
Primary completion	20 June 2020
Estimated completion	20 June 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

Azithromycin 250Mg Capsule — full drug profile →

Conditions studied

Sarcoidosis, Pulmonary — all drugs for Sarcoidosis, Pulmonary →

Sponsor

Hull University Teaching Hospitals NHS Trust

Who can join

Adults 18 to 80, any sex, with Sarcoidosis, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 beneficial immune modulating activity and are safe for long-term use. Recently, increased activity of the mTOR intracellular signalling pathway in inflammatory cells has emerged as a key driver of granulomatous inflammation in mouse models and patients with sarcoidosis. The macrolide antibiotic azithromycin directly inhibits mTOR activity in inflammatory cells, making it a prime target for drug repurposing in sarcoidosis. Azithromycin has an acceptable tolerability profile when used for long-term treatment of other chronic respiratory disease Single centre open label clinical trial of oral azithromycin 250 mg once daily for 3 months in 20-30 patients with pulmonary sarcoidosis. The Investigator have opted for an open label study because this will be the first study of azithromycin in sarcoidosis. Trial assessments will be performed according to standards of Good Clinical Practice with assessments at baseline, 1, and 3 months. All other clinical care, investigations, and treatment (if indicated) will remain the responsibility of the treating physician and based on clinical MDT consensus decisions.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

An up-to-date overview of computational polypharmacology in modern drug discovery.
Chaudhari R, Fong LW, Tan Z, Huang B, et al · · 2020 · cited 46× · PMID 32452701 · DOI 10.1080/17460441.2020.1767063
Refractory Sarcoidosis: A Review.
El Jammal T, Jamilloux Y, Gerfaud-Valentin M, Valeyre D, et al · · 2020 · cited 45× · PMID 32368072 · DOI 10.2147/tcrm.s192922
Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches.
Obi ON, Saketkoo LA, Russell AM, Baughman RP. · · 2022 · cited 31× · PMID 36314034 · DOI 10.3389/fmed.2022.991783
Emerging role of mTOR in tumor immune contexture: Impact on chemokine-related immune cells migration.
Jin J, Zhao Q. · · 2020 · cited 28× · PMID 32483450 · DOI 10.7150/thno.45219

Verify or expand the search:

Other recruiting trials for Sarcoidosis, Pulmonary

Currently open trials in the same condition.

NCT05841758 — Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis · Phase 4 · recruiting
NCT06479603 — RCT of Nintedanib in Fibrotic Sarcoidosis · Phase 4 · recruiting
NCT05746039 — Feasibility of Semaglutide in Advanced Lung Disease · Phase 1, PHASE2 · recruiting
NCT05291468 — the PHENOSAR Trial: Use of Antibiotics in Treatment of Sarcoidosis · NA · active not recruiting
NCT05567133 — Risk Indicators of Sarcoidosis Evolution-Unified Protocol · recruiting

Other Hull University Teaching Hospitals NHS Trust trials

Trials by the same sponsor.

NCT07502040 — Impact of Exercise Access on Physio Outcomes Post Knee Replacement · NA · not yet recruiting
NCT07483502 — The Effects of a 6-week Pre-operative Administration of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Sur · NA · not yet recruiting
NCT07427550 — Palliative Care and The Terminally Ill Adults (End of Life) Bill · not yet recruiting
NCT06876506 — Identification of B Regulatory Cells by Flow Cytometry · not yet recruiting
NCT07409519 — Nutritional Screening in Cardiovascular Disease · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04020380 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hull University Teaching Hospitals NHS Trust
Last refreshed: 16 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04020380.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing