Randomized Controlled Trial of Hydroxychloroquine Combined With Low-dose Corticosteroid in Pulmonary Sarcoidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

"The reference treatment for pulmonary sarcoidosis is prolonged systemic corticosteroid therapy, which improves dyspnea, fatigue and respiratory function. However, corticosteroid therapy doesn't improve quality of life, possibly due to its adverse effects. Furthermore, in an international survey study, the first priority in treatment outcome for sarcoidosis patient was quality of life.

Hydroxychloroquine an antimalarial drug, has been shown to be effective in cutaneous and pulmonary forms of sarcoidosis but in studies with imperfect methodology. Our hypothesis is that hydroxychloroquine associated with low-dose corticosteroids improves lung function as much as ""conventional"" medium-dose corticosteroid therapy but with fewer side effects and a better quality of life in pulmonary sarcoidosis. "

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis

NCT05841758

Sarcoidosis, Pulmonary

RECRUITING PHASE4

Hematopoietic Stem Cell Support in Patients With Refractory Sarcoidosis

NCT00282438

Sarcoidosis

TERMINATED PHASE1/PHASE2

"Randomized Controlled Trial Testing the Efficacy of Corticosteroid Therapy Versus Placebo in Fibrotic Hypersensitivity Pneumonitis"

NCT07210008

Hypersensitivity Pneumonitis

NOT_YET_RECRUITING PHASE3

A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis

NCT01732211

Pulmonary Sarcoidosis

TERMINATED PHASE2

Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis

NCT04008069

Sarcoidosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

"Sarcoidosis is a systemic granulomatosis of unknown etiology with almost systematic pulmonary involvement. The reference treatment for pulmonary sarcoidosis is prolonged systemic corticosteroid therapy, which improves dyspnea, fatigue and respiratory function. However, corticosteroid therapy doesn't improve quality of life, possibly due to its adverse effects, which are dose- and time-dependent, such as weight gain, diabetes, insomnia, hypertension. Furthermore, in an international survey study, the first priority in treatment outcome for sarcoidosis patient was quality of life. Recent optimizations have reduced the attack treatment duration from 3 to 1 month, but with a persistence of adverse effects appearing in the first months.

Hydroxychloroquine is an antimalarial drug, used for systemic lupus erythematosus with a very good benefit/risk ratio and low cost, but also for rheumatoid arthritis. Its anti-inflammatory effects involve inhibition of antigenic presentation, chemotaxis, phagocytosis, lymphocyte proliferation, cytokine production (e.g TNFα), or Toll-like receptors expression. These immunological mechanisms are also involved in the pathogenesis of sarcoidosis. In addition, Hydroxychloroquine decreases the risk of developing diabetes mellitus, dyslipidemia or thrombotic events. Hydroxychloroquine has been shown to be effective in cutaneous and pulmonary forms of sarcoidosis, and in hypercalcemia, but in studies with imperfect methodology. Baltzan et al. showed that a maintenance treatment of hydroxychloroquine versus placebo reduced the risk of relapse and lung function decline in pulmonary sarcoidosis. Our hypothesis is that hydroxychloroquine associated with low-dose corticosteroids improves lung function as much as ""conventional"" medium-dose corticosteroid therapy but with fewer side effects and a better quality of life in pulmonary sarcoidosis. The main objective is to demonstrate the non-inferiority of the combination of hydroxychloroquine and low-dose corticosteroids versus medium-dose corticosteroid therapy on the improvement of respiratory function at 6 months.

The secondary objectives are to (i) demonstrate the superiority of the combination of hydroxychloroquine and low-dose corticosteroids versus medium-dose corticosteroid therapy at 3, 6 months and 1 year on general quality of life, respiratory quality of life, fatigue, adverse drug event, treatment compliance and (ii) demonstrate the non-inferiority of the combination of hydroxychloroquine and low-dose corticosteroids versus medium-dose corticosteroid therapy at 3, 6 months and 1 year on : respiratory function using complementary tools, respiratory symptoms, and activity of thoracic and extra-thoracic sarcoidosis. "

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Sarcoidosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hydroxychloroquine+low-dose prednisone

Hydroxychloroquine, tablets, 400mg/day for 6 months combined with Prednisone, 20mg/day for 1 month, then 10mg/day for 20 weeks (ie up to M6). The cumulative doses of prednisone during the 6 months of the study will be 1820mg

Group Type EXPERIMENTAL

Hydroxychloroquine + low-dose prednisone

Intervention Type DRUG

Hydroxychloroquine, tablets, 400mg/day for 6 months combined with Prednisone, 20mg/day for 1 month, then 10mg/day for 20 weeks (ie up to M6). The cumulative doses of prednisone during the 6 months of the study will be 1820mg

Medium-dose prednisone

"prednisone, tablets, 40mg/day for 4 weeks, then 30mg/day for 2 weeks, then 20mg/day for 2 weeks, then 15mg/day for 2 weeks, then 10mg/day for 14 weeks (i.e. up to M6).

The cumulative doses of prednisone during the 6 months of the study will be 2870mg "

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

"prednisone, tablets, 40mg/day for 4 weeks, then 30mg/day for 2 weeks, then 20mg/day for 2 weeks, then 15mg/day for 2 weeks, then 10mg/day for 14 weeks (i.e. up to 6 months ).

The cumulative doses of prednisone during the 6 months of the study will be 2870mg "

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydroxychloroquine + low-dose prednisone

Hydroxychloroquine, tablets, 400mg/day for 6 months combined with Prednisone, 20mg/day for 1 month, then 10mg/day for 20 weeks (ie up to M6). The cumulative doses of prednisone during the 6 months of the study will be 1820mg

Intervention Type DRUG

Prednisone

"prednisone, tablets, 40mg/day for 4 weeks, then 30mg/day for 2 weeks, then 20mg/day for 2 weeks, then 15mg/day for 2 weeks, then 10mg/day for 14 weeks (i.e. up to 6 months ).

The cumulative doses of prednisone during the 6 months of the study will be 2870mg "

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Experimental Arm Standard Arm

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 18-80 years old
* Pulmonary sarcoidosis meeting the diagnostic criteria form ATS 2020 AJRCCM diagnostic criteria.
* Patient with radiographic stage II (mediastinal-hilar bilateral lymphadenopathy and parenchymal involvement) or III (involvement pulmonary parenchymatous) and FVC\<80% and respiratory symptom(s) among the following: cough, dyspnea, chest pain).
* Effective contraception for women of childbearing ages
* Informed consent signed.
* Affiliation to the social security system

Exclusion Criteria

* Severe impairment requiring an immediate and urgent result and/or high doses of corticosteroids (neurological, cardiac, ophthalmic (severe uveitis with ocular sequala), laryngeal, nasosinusal, renal, severe hypercalcemia)
* Cardiomyopathy with heart failure
* Presence of other conditions that may influence respiratory function: COPD, Asthma, Obesity (BMI\>30) pulmonary fibrosis disease, pulmonary neoplasia;
* Contraindication to hydroxychloroquinehypersensitivity to active substances or to excipients, retinopathy or severe cataract, or unilateral blindness, QTc prolongation, exposure to known treatments to prolong QT)
* Tamoxifen use
* Renal insufficiency with clearance \<60ml/min
* History of retinopathy or maculopathy
* Contraindication to corticosteroid therapy (hypersensitivity of active substancies, infections and progressive virosis, glaucoma, psychotic state not controlled by treatment, live vaccine, uncontrolled diabetes mellitus and hypertension)
* Intermittent porphyria (risk of acute porphyria crisis)
* Glucose-6-Phosphate Dehydrogenase deficiency
* Seropositivity to HIV, HBV, HCV
* Systemic corticosteroid therapy or immunosuppressive therapy for at least 7 days in the previous year;
* History of treatment with hydroxychloroquine for sarcoidosis;
* Current pregnancy,
* Breastfeeding,
* Patient unable to answer questionnaires despite the presence of a caregiver.
* Patient under trustee
* Patient under legal protection
* Participation in another therapeutic interventional trial within 6 months of inclusion

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No