Trial reportChest2021
Phase II Investigation of the Efficacy of Antimycobacterial Therapy in Chronic Pulmonary Sarcoidosis.
Trial report in Chest, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 46 citations in OpenAlex.
- Trial
- Mycobacterium tuberculosis-specific blood immune signatures distinguish sarcoidosis from tuberculosis disease.Journal of immunology (Baltimore, Md. : 1950) · 2026Article
- Endogenous Hypersensitivity Infection: A Unifying Framework forMicroorganisms · 2026Review
- Gut microbiota and sarcoidosis: a concise review.Frontiers in medicine · 2026Review
- Diagnosis and treatment of sarcoidosis based on immunological etiology and mechanisms.Frontiers in medicine · 2026Review
- Long-Term Macrolides in Chronic Respiratory Diseases: Dusk or a New Dawn? A Narrative Review.Antibiotics (Basel, Switzerland) · 2025Review
- Immunosuppressive Therapies in Pulmonary Sarcoidosis: A Practical, Evidence-Based Review.Journal of clinical medicine · 2025Review
- Delays in Referral to Multidisciplinary Care for Black Individuals With Sarcoidosis.CHEST pulmonary · 2025Article
- Sarcoidosis: molecular mechanisms and therapeutic strategies.Molecular biomedicine · 2025Review
- Phenotypes and Endotypes in Sarcoidosis: Unraveling Prognosis and Disease Course.Biomedicines · 2025Review
- Latent microbial reactivation and immune dysregulation in sarcoidosis: bridging pathogenesis and precision therapeutics.Frontiers in medicine · 2025Review
- Case Report: Sarcoidosis or tuberculosis? A continuous challenge.Frontiers in medicine · 2025Article
- Infectious and non-infectious precipitants of sarcoidosis.Journal of autoimmunity · 2024Review
- Review
- D. Geraint James Lecture: The sarcoidosis saga: what insights from the past will guide us in the future.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2023Article
- Diagnosis of pulmonary sarcoidosis in tuberculosis endemic area-a narrative review.Journal of thoracic disease · 2023Review
- Sarcoidosis,Microorganisms · 2023Review
- The Evolving Landscape of Cutaneous Sarcoidosis: Pathogenic Insight, Clinical Challenges, and New Frontiers in Therapy.American journal of clinical dermatology · 2022Review
- Delivering macrolide antibiotics to heal a broken heart - And other inflammatory conditions.Advanced drug delivery reviews · 2022Review
- Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches.Frontiers in medicine · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundA Phase I, single-center investigation found that 8 weeks of antimycobacterial therapy improved sarcoidosis FVC. Safety and efficacy assessments have not been performed in a multicenter cohort. RESEARCH QUESTION: The objective of this study was to determine the safety and efficacy of antimycobacterial therapy on the physiological and immunologic end points of sarcoidosis. STUDY DESIGN AND
methodsIn a double-blind, placebo-controlled, multicenter investigation, patients with pulmonary sarcoidosis were randomly assigned to receive 16 weeks of concomitant levofloxacin, ethambutol, azithromycin, and rifabutin (CLEAR) or matching placebo to investigate the effect on FVC. The primary outcome was a comparison of change in percentage of predicted FVC among patients randomized to receive CLEAR or placebo in addition to their baseline immunosuppressive regimen. Secondary outcomes included 6-min walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ) score, adverse events, and decrease in mycobacterial early secreted antigenic target of 6 kDa (ESAT-6) immune responses.
resultsThe intention-to-treat analysis revealed no significant differences in change in FVC among the 49 patients randomized to receive CLEAR (1.1% decrease) compared with the 48 randomized to receive placebo (0.02% increase) (P = .64). Physiological parameters such as the change in 6MWD were likewise similar (P = .91); change in SGRQ favored placebo (-8.0 for placebo vs -1.5 for CLEAR; P = .028). The per-protocol analysis revealed no significant change in FVC at 16 weeks between CLEAR and placebo. There was no significant change in 6MWD (36.4 m vs 6.3 m; P = .24) or SGRQ (-2.3 vs -7.0; P = .14). A decline in ESAT-6 immune responses at 16 weeks was noted among CLEAR-treated patients (P = .0003) but not patients receiving placebo (P = .24).
interpretationDespite a significant decline in ESAT-6 immune responses, a 16-week CLEAR regimen provided no physiological benefit in FVC or 6MWD among patients with sarcoidosis.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.