Lung Diseases, InterstitialNCT05503030
Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
An observational study of Lung Diseases, Interstitial, run by Boehringer Ingelheim at 20 sites in Greece.
Trial summary
The aim of this study is to identify correlations between change from the baseline at Month 24 in Forced Vital Capacity (FVC) (% predicted and mL) and change from the baseline at Month 24 in cough or dyspnoea scores [points] as measured in the living with pulmonary fibrosis questionnaire (L-PF) over 24 months of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Nintedanib
- How many people
- 88 participants
- Where
- 20 sitesGreece
- Study dates
- 21 Dec 2022to 13 May 2026
- 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: Patients with physician-diagnosed interstitial lung disease (ILD) must fulfil at least one of the following criteria for progressive fibrosing (PF)-ILD within the previous period and up to two years before the screening, despite standard treatment to treat ILD: * Clinically significant decline in forced vital capacity (FVC) percentage (%) predicted based on a relative decline of ≥ 10% * The marginal decline in FVC % predicted based on a relative decline of ≥ 5-< 10% combined with worsening respiratory symptoms * The marginal decline in FVC % predicted based on a relative decline of ≥ 5-< 10% combined with increasing extent of fibrotic changes on chest imaging * Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging All patients will need to be treatment naïve concerning antifibrotic treatments (i.e., nintedanib or pirfenidone) before initiating nintedanib. Enrolment period will be 24 months, and each participant will be observed for 24 months.
Who may be able to join
- Age ≥18 years with a confirmed physician diagnosis of connective tissue disease (CTD) associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
- Have been prescribed nintedanib according to the local Summary of Product Characteristics (SmPC) and clinical judgment. Therapy with nintedanib must have been started for clinical reasons independently from the intended patient enrolment into the study at a maximum of 15 days before enrolment into the trial.
Who cannot join
- Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nintedanib
- Patients at baseline with a known condition or reason that will result in withdrawal from the study before the 24-month time point
- Pregnancy or lactation
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Greece20 sites
Private physician
Athens, 10676
Private physician
Athens, 11362
"G. Gennimatas" General Hospital of Athens
Athens, 11527
"Ippokration" General Hospital of Athens
Athens, 11527
"Laiko" General Hospital of Athens
Athens, 11527
Private physician
Athens, 11634
"ATTIKON" University General Hospital
Athens, 12462
"KAT" General Hospital
Athens, 14561
University General Hospital of Heraklion
Heraklion, 71003
University General Hospital of Heraklion
Heraklion, 71110
Private physician
Ioannina, 45332
University General Hospital of Ioannina
Ioannina, 45500
Private physician
Larissa, 41222
University General Hospital of Larisa
Larissa, 41334
Private physician
Nea Smirni, Athens, 17121
Private physician
Pátrai, 26504
University General Hospital of Patra
Pátrai, 26504
Private physician
Thessaloniki, 54622
"Hippokration" General Hospital of Thessaloniki
Thessaloniki, 54642
"G. Papanikolaou" General University of Thessaloniki
Thessaloniki, 57010
About this study
Official title: A Prospective, Observational Study on the Correlations Between Change in Lung Function and Change in Cough and Dyspnoea in Patients With Connective Tissue Disease-associated Progressive Fibrosing INTErstitial luNg diseaSE (CTD Associated PF-ILD) Treated With Nintedanib. The "INTENSE" Study
The aim of this study is to identify correlations between change from the baseline at Month 24 in Forced Vital Capacity (FVC) (% predicted and mL) and change from the baseline at Month 24 in cough or dyspnoea scores [points] as measured in the living with pulmonary fibrosis questionnaire (L-PF) over 24 months of nintedanib treatment in patients with connective tissues disease-associated progressive fibrosing interstitial lung disease (CTD associated PF-ILD) under routine clinical practice conditions in Greece.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Nintedanib
- 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.
NintedanibDrug
Nintedanib
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib for CTD-associated PF-ILD patients in Greece | Connective Tissue Disease (CTD)-associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Receives: Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [percentage (%) predicted] and change from baseline at Month 24 in dyspnoea symptom score [points]
The "living with pulmonary fibrosis" (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of health related quality of life (HRQoL) over the last 7 days. Symptoms and Impacts scores are used to calculate a total score.
Items in both modules have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely". Overall scores range from 0 to 100, with higher numbers indicating a greater impairment.
Measured: At baseline and at month 24
Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [% predicted] and change from baseline at Month 24 in cough symptom score [points]
Measured: At baseline and at month 24
Secondary outcomes (9)
Correlation between the change from baseline at Month 24 in forced vital capacity (FVC) [milliLitres (mL)] and change from baseline at Month 24 in dyspnoea symptom score [points]
Measured: At baseline and at month 24
Correlation between change from baseline at Month 24 in FVC [mL] and change from baseline at Month 24 in cough symptom score [points]
Measured: At baseline and at month 24
Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24
Measured: At baseline and at month 24
Correlation between baseline FVC [% pred] and change in cough symptom score [points] from baseline at month 24
Measured: At baseline and at month 24
Absolute change from baseline in FVC [% pred] at month 24
Measured: At baseline and at month 24
Absolute change from baseline in FVC [mL] at month 24
Measured: At baseline and at month 24
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] at month 24
Measured: At baseline and at month 24
Absolute change from baseline in L-PF cough symptom score [points] at month 24
Measured: At baseline and at month 24
Change in total L-PF score [points] from baseline at month 24, or the end of the observation
Measured: At baseline and up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start21 Dec 2022
- Primary completion13 May 2026
- Study completion13 May 2026
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503030
- Sponsor's protocol ID
- 1199-0501
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study on the Correlations Between Change in Lung Function and Change in Cough and Dyspnoea in Patients With Connective Tissue Disease-associated Progressive Fibrosing INTErstitial luNg diseaSE (CTD Associated PF-ILD) Treated With Nintedanib. The "INTENSE" Study
- ClinicalTrials.gov ID
- NCT05503030
- Acronym / sponsor ID
- 1199-0501
- Conditions
- Lung Diseases, Interstitial
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 16 Aug 2022 (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.
The aim of this study is to identify correlations between change from the baseline at Month 24 in Forced Vital Capacity (FVC) (% predicted and mL) and change from the baseline at Month 24 in cough or dyspnoea scores [points] as measured in the living with pulmonary fibrosis questionnaire (L-PF) over 24 months of nintedanib treatment in patients with connective tissues disease-associated progressive fibrosing interstitial lung disease (CTD associated PF-ILD) under routine clinical practice conditions in Greece.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nintedanib for CTD-associated PF-ILD patients in Greece | – | Drug: NintedanibConnective Tissue Disease (CTD)-associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with physician-diagnosed interstitial lung disease (ILD) must fulfil at least one of the following criteria for progressive fibrosing (PF)-ILD within the previous period and up to two years before the screening, despite standard treatment to treat ILD: * Clinically significant decline in forced vital capacity (FVC) percentage (%) predicted based on a relative decline of ≥ 10% * The marginal decline in FVC % predicted based on a relative decline of ≥ 5-< 10% combined with worsening respiratory symptoms * The marginal decline in FVC % predicted based on a relative decline of ≥ 5-< 10% combined with increasing extent of fibrotic changes on chest imaging * Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging All patients will need to be treatment naïve concerning antifibrotic treatments (i.e., nintedanib or pirfenidone) before initiating nintedanib. Enrolment period will be 24 months, and each participant will be observed for 24 months.
Key inclusion criteria (2 listed)
- Age ≥18 years with a confirmed physician diagnosis of connective tissue disease (CTD) associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
- Have been prescribed nintedanib according to the local Summary of Product Characteristics (SmPC) and clinical judgment. Therapy with nintedanib must have been started for clinical reasons independently from the intended patient enrolment into the study at a maximum of 15 days before enrolment into the trial.
Key exclusion criteria (3 listed)
- Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nintedanib
- Patients at baseline with a known condition or reason that will result in withdrawal from the study before the 24-month time point
- Pregnancy or lactation
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 |
|---|---|---|
| NintedanibNintedanib | Drug | Nintedanib for CTD-associated PF-ILD patients in Greece |
Primary outcome
Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [percentage (%) predicted] and change from baseline at Month 24 in dyspnoea symptom score [points]
Time frame: At baseline and at month 24
The "living with pulmonary fibrosis" (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of health related quality of life (HRQoL) over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. Items in both modules have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely". Overall scores range from 0 to 100, with higher numbers indicating a greater impairment.
Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [% predicted] and change from baseline at Month 24 in cough symptom score [points]
Time frame: At baseline and at month 24
9 secondary outcomes
Correlation between the change from baseline at Month 24 in forced vital capacity (FVC) [milliLitres (mL)] and change from baseline at Month 24 in dyspnoea symptom score [points]
Time frame: At baseline and at month 24
Correlation between change from baseline at Month 24 in FVC [mL] and change from baseline at Month 24 in cough symptom score [points]
Time frame: At baseline and at month 24
Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24
Time frame: At baseline and at month 24
Correlation between baseline FVC [% pred] and change in cough symptom score [points] from baseline at month 24
Time frame: At baseline and at month 24
Absolute change from baseline in FVC [% pred] at month 24
Time frame: At baseline and at month 24
Absolute change from baseline in FVC [mL] at month 24
Time frame: At baseline and at month 24
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] at month 24
Time frame: At baseline and at month 24
Absolute change from baseline in L-PF cough symptom score [points] at month 24
Time frame: At baseline and at month 24
Change in total L-PF score [points] from baseline at month 24, or the end of the observation
Time frame: At baseline and up to 24 months
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Interstitial, run by Boehringer Ingelheim at 20 sites in Greece.
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 3 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: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Greece. 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?
The study was stopped early (reason given: Company decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [percentage (%) predicted] and change from baseline at Month 24 in dyspnoea symptom score [points] (time frame: At baseline and at month 24). The study lists 2 primary outcomes in all. 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 15 Jun 2026.