A Phase 2 interventional study of Azithromycin 250 mg x3/week (3 tablets/week) and Prednisone 10 mg/day in Interstitial Lung Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
Among 12 studies in Lung Diseases, Interstitial by Assistance Publique - Hôpitaux de Paris — 5 open to participants now, 7 under way, none of them phase 3. Lung Diseases, Interstitial · Assistance Publique - Hôpitaux de Paris.
Among the 12 studies in Lung Diseases, Interstitial by Assistance Publique - Hôpitaux de Paris, this one is one of 2 that started in 2026, is one of 3 in phase 2, and was the 11th registered.
680 studies on the registry are indexed under Lung Diseases, Interstitial; 246 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 384 interventional studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →5 of the 12 studies in Lung Diseases, Interstitial by Assistance Publique - Hôpitaux de Paris are open now, in 1 country. Each count lists the studies.
Of the 174 Lung Diseases, Interstitial studies recruiting now, 109 (63%) set no upper age limit and 26 (15%) stop at 75 or younger; 13 take children under 18; 22 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2026.
Median enrollment 40 across the 7 interventional studies, 300 across the 5 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
4 of the studies in Lung Diseases, Interstitial by Assistance Publique - Hôpitaux de Paris that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07631208Assistance Publique - Hôpitaux de ParisStudy of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5 | 2027-01 |
| NCT06743022Assistance Publique - Hôpitaux de ParisEvaluation of the Reproducibility of the Automated Measurement of the Extent of ILD on Chest CT | 2027-08 |
| NCT04227535Assistance Publique - Hôpitaux de ParisDeciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2 | 2027-10-01 |
| NCT07443436Assistance Publique - Hôpitaux de ParisImmunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants | 2027-11-01 |
Among the 12 studies in Lung Diseases, Interstitial by Assistance Publique - Hôpitaux de Paris, from their registry updates:
Nothing recorded among them since 2026-09-25.
Scientific justification : Variants in surfactant-related genes (SRG) explain approximately 6% of familial pulmonary fibrosis (FPF).
The pathophysiology is unknown and seems to involve endoplasmic reticulum stress in type 2 alveolar epithelial cells.
Variable improvement in the prognosis of childhood and adult interstitial lung disease (ILD) associated with a variant of a SRG, initially reported to be lethal within months of diagnosis, has been observed since the consensual use of prednisone, azithromycin and hydroxychloroquine targeting endoplasmic reticulum stress, without demonstration of the efficacy of any of these treatments alone or in combination.
The investigators hypothesize that a treatment combining prednisone, azithromycin and hydroxychloroquine is safe and could improve the prognosis of adult patients with ILD associated with SRG variant.
Main objective and primary endpoint : Main objective:
Evaluate the efficacy of triple immunomodulatory therapy (prednisone, azithromycin and hydroxychloroquine) for 12 months in patients with ILD associated with a variant of a surfactant-related gene.
Primary endpoint:
Difference in forced vital capacity decline between the 2 groups at one year.
Secondary objectives and endpoints : Secondary objectives:
Secondary endpoints:
Design of the study : Multicenter, randomized, controlled, two-arm, parallel, open-label superiority study comparing triple immunomodulatory therapy (prednisone, azithromycin, and hydroxychloroquine) to standard of care
Category : Category 2
Population of study participants: Patients aged over 18 years with ILD and SRG variant
Number of participants included : 30
Design of the study : Multicenter, randomized, controlled, two-arm, parallel, open-label superiority study comparing triple immunomodulatory therapy (prednisone, azithromycin, and hydroxychloroquine) to standard of care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental treatment will be the combination of: * Prednisone 10 mg/day (1 tablet/day) * Hydroxychloroquine 400 mg/day (2 tablets/day) * Azithromycin 250 mg x3/week (3 tablets/week) Route of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no
Drug: Azithromycin 250 mg x3/week (3 tablets/week) · Drug: Prednisone 10 mg/day · Drug: Hydroxychloroquine 400 mg/day
Standard of care: any symptomatic treatment to interstitial lung disease. No other experimental or off-label treatment (such as ivacaftor) will be allowed during the study.
Drug: Active Comparator: Standard of care
Drug page: Azithromycin
Route of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no
Drug page: Prednisone
Route of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no
Drug page: Hydroxychloroquine
Route of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no
Standard of care: any symptomatic treatment to interstitial lung disease. No other experimental or off-label treatment (such as ivacaftor) will be allowed during the study.
Difference in forced vital capacity decline between the 2 groups at one year.
Evaluate the efficacy of triple immunomodulatory therapy (prednisone, azithromycin and hydroxychloroquine) for 12 months in patients with ILD associated with a variant of a surfactant-related gene.
Time frame: 12 Months
tolerance of the triple therapy
Clinical and biological tolerance (occurrence of an adverse effect during treatment), ECG (including QTc prolongation) (at 3, 6, 9, 12 months after randomization) (only HCQ or AZI patients) and ophthalmological (at 6 months and 12 months after randomization)
Time frame: 12 months
correlation between the respiratory, radiological and clinical functional response,
Thoracic CT scan (progression criteria \[99\]) and PFT (Pulmonary function tests) at one year after randomization
Time frame: 12 months
Quality of life of the patients
Quality of life questionnaire (SF-36, scale from 0 to 100, where 0 represents the poorest health and 100 represents the best possible health) (EORTC QLQ-C30, v3.0 : a validated patient-reported questionnaire for assessing quality of life in cancer patients.) at one year after randomization,
Time frame: 12 months
tolerance of the triple therapy
Clinical and biological tolerance (occurrence of an adverse effect during treatment), ECG (including QTc prolongation) at 6, months after randomization (only HCQ or AZI patients) and ophthalmological (at one year after randomization)
Time frame: 6 months
tolerance of the triple therapy
Clinical and biological tolerance (occurrence of an adverse effect during treatment), ECG (including QTc prolongation) at 3 months after randomization (only HCQ or AZI patients) and ophthalmological (at one year after randomization)
Time frame: 3 months
correlation between the respiratory, radiological and clinical functional response,
Thoracic CT scan (progression criteria \[99\]) and PFT (Pulmonary function tests) at 6 months after randomization
Time frame: 6 months
Quality of life of the patients
Quality of life questionnaire (SF-36,scale from 0 to 100, where 0 represents the poorest health and 100 represents the best possible health) (EORTC QLQ-C30, v3.0 : a validated patient-reported questionnaire for assessing quality of life in cancer patients.) at 9 months after randomization,
Time frame: 9 months
Quality of life of the patients
Quality of life questionnaire (SF-36 scale from 0 to 100, where 0 represents the poorest health and 100 represents the best possible health) (EORTC QLQ-C30, v3.0 :a validated patient-reported questionnaire for assessing quality of life in cancer patients. ) at 6 months after randomization,
Time frame: 6 months
Quality of life of the patients
Quality of life questionnaire (SF-36, scale from 0 to 100, where 0 represents the poorest health and 100 represents the best possible health) (EORTC QLQ-C30, v3.0 :a validated patient-reported questionnaire for assessing quality of life in cancer patients ) at 3 months after randomization,
Time frame: 3 months
Overall survival
Collection of vital status, lung transplantation, hospitalization for pulmonary and non-pulmonary causes and episodes of exacerbation at each visit until the end of follow-up 12 months after randomization
Time frame: 12 months
Transplant-free survival
Collection of vital status, lung transplantation, hospitalization for pulmonary and non-pulmonary causes and episodes of exacerbation at each visit until the end of follow-up 12 months after randomization
Time frame: 12 months
Exacerbation free-survival
Collection of vital status, lung transplantation, hospitalization for pulmonary and non-pulmonary causes and episodes of exacerbation at each visit until the end of follow-up 12 months after randomization
Time frame: 12 months
Hospitalization-free survival
Collection of vital status, lung transplantation, hospitalization for pulmonary and non-pulmonary causes and episodes of exacerbation at each visit until the end of follow-up 12 months after randomization
Time frame: 12 months
tolerance of the triple therapy
Clinical and biological tolerance (occurrence of an adverse effect during treatment),
Time frame: 9 months
tolerance of the triple therapy
ECG (including QTc prolongation) at 12 months after randomization (only HCQ or AZI patients)
Time frame: 12 months
tolerance of the triple therapy
Ophthalmological (at one year after randomization)
Time frame: 12 months
tolerance of the triple therapy
ECG (including QTc prolongation) at , 9 months after randomization (only HCQ or AZI patients)
Time frame: 9 months
tolerance of the triple therapy
ECG (including QTc prolongation) at 6 months after randomization (only HCQ or AZI patients)
Time frame: 6 months
tolerance of the triple therapy
ECG (including QTc prolongation) at 3 months after randomization (only HCQ or AZI patients)
Time frame: 3 months
Overall survival
Collection of vital status, lung transplantation, hospitalization for pulmonary and non-pulmonary causes and episodes of exacerbation at each visit until the end of follow-up 9 months after randomization
Time frame: 9 months
Overall survival
Collection of vital status, lung transplantation, hospitalization for pulmonary and non-pulmonary causes and episodes of exacerbation at each visit until the end of follow-up 6 months after randomization
Time frame: 6 months
Overall survival
Collection of vital status, lung transplantation, hospitalization for pulmonary and non-pulmonary causes and episodes of exacerbation at each visit until the end of follow-up 3 months after randomization
Time frame: 3 months
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 53 phase 2 interventional studies under Lung Diseases, Interstitial, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 71. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Azithromycin · Prednisone · Hydroxychloroquine
Assistance Publique - Hôpitaux de Paris →