Interstitial Lung DiseasePhase 2TIPSNCT07443436
Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants
A Phase 2 study testing Azithromycin 250 mg x3/week (3 tablets/week), Prednisone 10 mg/day and Hydroxychloroquine 400 mg/day in people with Interstitial Lung Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Azithromycin 250 mg x3/week (3 tablets/week), Prednisone 10 mg/day and Hydroxychloroquine 400 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and <80 years
- Carrier of a variant classified as pathogenic or probably pathogenic or considered as eligible by the genetic multidisciplinary discussion in SFTPA1, SFTPA2, SFTPC, NKX2-1, SFTPB or two variants classified as pathogenic or probably pathogenic or considered as eligible by the genetic multidisciplinary discussion in ABCA3 or SFTPB
- ILD whatever the pattern corresponding to a volume > 10% of the total lung on a CT scan of less than 2 years
Who cannot join
- Contraindication to azithromycin and hydroxychloroquine and prednisone (details in section 6.2)
- Pregnancy and breastfeeding
- Female of childbearing potential* not willing to use reliable contraception from inclusion and during 22 months
- Desire to have a child within 22 months
- Enrolment to another interventional study (clinical trial on medicinal product, medical device and interventional research involving human participants not concerning health product)
- Subject deprived of their liberty or subject that may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests; or unable to explicitly give consent.
- No affiliation to any health insurance system
- Refusal to participate to the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BORIE Raphaël contact
France3 sites
Pneumologie Louis Pradel
Bron, 69500
COTTIN Vincent, vincent.cottin@chu-lyon.fr
Pneumologie Institu Coeur Poumon
Lille, 59037
WEMEAU Lidwine, lidwibne.wemeau@chru-lille.fr
Pneumologie Pontchaillou
Rennes, 35033
JOUNEAU Stéphane, stephane.jouneau@chu-rennes.fr
About this study
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.
Read more
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:
- tolerance of the triple therapy,
- correlation between the respiratory, radiological and clinical functional response,
- quality of life of the patients,
- overall survival, transplant-free survival, exacerbation free-survival, hospitalization-free survival
Secondary endpoints:
- Clinical and biological tolerance (occurrence of an adverse effect during treatment), ECG (at 3, 6, 9, 12 months after randomization) (only HCQ or AZI patients) and ophthalmological (at one year after randomization)
- Thoracic CT scan and PFT at 6 months and one year after randomization
- Quality of life questionnaire (EORTC QLQ-C30, v3.0) at 3 months, 6 months, 9 months and one year after randomization,
- 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.
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.
- Conditions
- Interstitial Lung Disease
- Being tested
- Azithromycin 250 mg x3/week (3 tablets/week), Prednisone 10 mg/day, Hydroxychloroquine 400 mg/day, Active Comparator: Standard of care
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin 250 mg x3/week (3 tablets/week)Drug
Route of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no
Prednisone 10 mg/dayDrug
Route of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no
Hydroxychloroquine 400 mg/dayDrug
Route of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no
Active Comparator: Standard of careDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone 10 mg/day -Hydroxychloroquine 400 mg/day - Azithromycin 250mg*3 | Experimental | 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 Receives: Drug: Azithromycin 250 mg x3/week (3 tablets/week); Drug: Prednisone 10 mg/day; Drug: Hydroxychloroquine 400 mg/day |
| Standard of care | Active comparator | 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. Receives: Drug: Active Comparator: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (22)
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)
Measured: 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
Measured: 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,
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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,
Measured: 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,
Measured: 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,
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
tolerance of the triple therapy
Clinical and biological tolerance (occurrence of an adverse effect during treatment),
Measured: 9 months
tolerance of the triple therapy
ECG (including QTc prolongation) at 12 months after randomization (only HCQ or AZI patients)
Measured: 12 months
tolerance of the triple therapy
Ophthalmological (at one year after randomization)
Measured: 12 months
tolerance of the triple therapy
ECG (including QTc prolongation) at , 9 months after randomization (only HCQ or AZI patients)
Measured: 9 months
tolerance of the triple therapy
ECG (including QTc prolongation) at 6 months after randomization (only HCQ or AZI patients)
Measured: 6 months
tolerance of the triple therapy
ECG (including QTc prolongation) at 3 months after randomization (only HCQ or AZI patients)
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443436
- Sponsor's protocol ID
- APHP251230
- Acronym
- TIPS
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants
- ClinicalTrials.gov ID
- NCT07443436
- Acronym / sponsor ID
- TIPS / APHP251230
- Conditions
- Interstitial Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- tolerance of the triple therapy,
- correlation between the respiratory, radiological and clinical functional response,
- quality of life of the patients,
- overall survival, transplant-free survival, exacerbation free-survival, hospitalization-free survival
Secondary endpoints:
- Clinical and biological tolerance (occurrence of an adverse effect during treatment), ECG (at 3, 6, 9, 12 months after randomization) (only HCQ or AZI patients) and ophthalmological (at one year after randomization)
- Thoracic CT scan and PFT at 6 months and one year after randomization
- Quality of life questionnaire (EORTC QLQ-C30, v3.0) at 3 months, 6 months, 9 months and one year after randomization,
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone 10 mg/day -Hydroxychloroquine 400 mg/day - Azithromycin 250mg*3 | Experimental | Drug: Azithromycin 250 mg x3/week (3 tablets/week), Drug: Prednisone 10 mg/day, Drug: Hydroxychloroquine 400 mg/dayThe 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 |
| Standard of care | Active comparator | Drug: Active Comparator: Standard of careStandard 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years and <80 years
- Carrier of a variant classified as pathogenic or probably pathogenic or considered as eligible by the genetic multidisciplinary discussion in SFTPA1, SFTPA2, SFTPC, NKX2-1, SFTPB or two variants classified as pathogenic or probably pathogenic or considered as eligible by the genetic multidisciplinary discussion in ABCA3 or SFTPB
- ILD whatever the pattern corresponding to a volume > 10% of the total lung on a CT scan of less than 2 years
Key exclusion criteria (8 listed)
- Contraindication to azithromycin and hydroxychloroquine and prednisone (details in section 6.2)
- Pregnancy and breastfeeding
- Female of childbearing potential* not willing to use reliable contraception from inclusion and during 22 months
- Desire to have a child within 22 months
- Enrolment to another interventional study (clinical trial on medicinal product, medical device and interventional research involving human participants not concerning health product)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Prednisone 10 mg/day -Hydroxychloroquine 400 mg/day - Azithromycin 250mg*3 |
| Prednisone 10 mg/dayRoute of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no | Drug | Prednisone 10 mg/day -Hydroxychloroquine 400 mg/day - Azithromycin 250mg*3 |
| Hydroxychloroquine 400 mg/dayRoute of administration: oral route Duration of treatment: 12 months Market authorization: yes Use in their market authorization indication: no | Drug | Prednisone 10 mg/day -Hydroxychloroquine 400 mg/day - Azithromycin 250mg*3 |
| Active Comparator: Standard of careStandard 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 | Standard of care |
Primary outcome
Difference in forced vital capacity decline between the 2 groups at one year.
Time frame: 12 Months
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.
22 secondary outcomes
tolerance of the triple therapy
Time frame: 12 months
correlation between the respiratory, radiological and clinical functional response,
Time frame: 12 months
Quality of life of the patients
Time frame: 12 months
tolerance of the triple therapy
Time frame: 6 months
tolerance of the triple therapy
Time frame: 3 months
correlation between the respiratory, radiological and clinical functional response,
Time frame: 6 months
Quality of life of the patients
Time frame: 9 months
Quality of life of the patients
Time frame: 6 months
Quality of life of the patients
Time frame: 3 months
Overall survival
Time frame: 12 months
Transplant-free survival
Time frame: 12 months
Exacerbation free-survival
Time frame: 12 months
Hospitalization-free survival
Time frame: 12 months
tolerance of the triple therapy
Time frame: 9 months
tolerance of the triple therapy
Time frame: 12 months
tolerance of the triple therapy
Time frame: 12 months
tolerance of the triple therapy
Time frame: 9 months
tolerance of the triple therapy
Time frame: 6 months
tolerance of the triple therapy
Time frame: 3 months
Overall survival
Time frame: 9 months
Overall survival
Time frame: 6 months
Overall survival
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BORIE Raphaël contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin 250 mg x3/week (3 tablets/week), Prednisone 10 mg/day and Hydroxychloroquine 400 mg/day in people with Interstitial Lung Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annabelle METOIS (0140257939, annabelle/metois@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in forced vital capacity decline between the 2 groups at one year. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.