Interstitial Lung DiseaseRESPIRARENCT06645977
Patients With Interstitial Lung Disease
An observational study of Interstitial Lung Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Prospective monocentric collection of data from adult patients with interstitial lung disease (ILD), to provide real-world data on current patient management at the ILD clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 4 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with interstitial lung disease from ILD clinic of the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.
Who may be able to join
- Age >= 18 years
- Diagnosis of ILD, according to international guidelines.
Who cannot join
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Rome, RM, 00168
Luca Richeldi, luca.richeldi@policlinicogemelli.it
About this study
Official title: Prospective Observational Study of Patients With Interstitial Lung Disease (RESPIRARE)
Prospective monocentric collection of data from adult patients with interstitial lung disease (ILD), to provide real-world data on current patient management at the ILD clinic.
- Conditions
- Interstitial Lung Disease
- Medical subject headings
- Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalce ILD
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Apr 2024
- Primary completion4 Apr 2025 (estimated)
- Study completion4 Apr 2025 (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 Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RICHELDI LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645977
- Sponsor's protocol ID
- 6393
- Acronym
- RESPIRARE
- Status last verified
- Oct 2024
- First submitted
- 18 Mar 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Patients With Interstitial Lung Disease (RESPIRARE)
- ClinicalTrials.gov ID
- NCT06645977
- Acronym / sponsor ID
- RESPIRARE / 6393
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 4 Apr 2025 (estimated)
- Study completion
- 4 Apr 2025 (estimated)
- First posted
- 17 Oct 2024 (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.
Prospective monocentric collection of data from adult patients with interstitial lung disease (ILD), to provide real-world data on current patient management at the ILD clinic.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with interstitial lung disease from ILD clinic of the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.
Key inclusion criteria (2 listed)
- Age >= 18 years
- Diagnosis of ILD, according to international guidelines.
Key exclusion criteria (1 listed)
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalce ILD
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Richeldi (0630157857, luca.richeldi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalce ILD (time frame: 5 years). 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 17 Oct 2024.