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Idiopathic Pulmonary FibrosisNCT02818712

Health-related Quality of Life and Comorbidities in Danish Patients With Idiopathic Pulmonary Fibrosis - a Nationwide Follow-up

An observational study of Idiopathic Pulmonary Fibrosis, run by Aarhus University Hospital at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality. Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known about the properties of recently developed HRQL questionnaires and about the longitudinal changes in HRQL, including factors with an impact on… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
How many people
150 participants
Where
3 sitesDenmark
Study dates
Aug 2016to Jun 2021
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: Incident and prevalent patients with IPF in Denmark.

Who may be able to join

  • A clinical diagnosis of IPF
  • Signed informed consent

Who cannot join

  • Clinical, radiological or histological findings inconsistent with a diagnosis of IPF
  • Inability or unwillingness to adhere to the study
  • Active on lung transplantation list

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Aarhus University Hosptial

    Aarhus C

  • Gentofte Hospital

    Hellerup

  • Odense University Hospital

    Odense

Other trials in Denmark

About this study

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality. Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known about the properties of recently developed HRQL questionnaires and about the longitudinal changes in HRQL, including factors with an impact on HRQL. Comorbidities have an impact on patients with IPF, but reports differ in incidence and prevalence. The impact of comorbidities on HRQL and disease progression has only been studied sparsely. Also, the association between biomarkers and disease progression need to be examined further.

Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02818712
Study groupRoleWhat they receive
Patients with IPFNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life

    Change in St. George's Respiratory Questionnaire

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

  2. Health-related quality of life

    Change in St. George's Respiratory Questionnaire, IPF-specific

    Measured: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months

  3. Health-related quality of life

    Changes in King's Brief Interstitial Lung Disease questionnaire

    Measured: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months

  4. Number and type of comorbidities

    Prevalence of comorbidities at baseline

    Measured: Baseline

  5. Number and type of comorbidities

    Incidence of new comorbidities after 6 months, 12 months, 24 months and 36 months

    Measured: Change/incidence at 6 months, 12 months, 24 months and 36 months

Secondary outcomes (9)

  1. Lung function tests

    Change in forced vital capacity

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

  2. Lung function tests

    Change in diffusion capacity for carbon monoxide

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

  3. 6-minute walk test

    Change in 6-minute walk test

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

  4. Progression in serum/plasma biomarker levels

    Increase or decrease in serum/plasma biomarker levels

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

  5. Health-related quality of life

    Change in Short Form 36

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

  6. Health-related quality of life

    Changes in University of California San Diego Shortness Of Breath Questionnaire

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

  7. Disease progression

    Change in interstitial changes on high resolution CT-scan (HRCT)

    Measured: Baseline, 12 months, 24 months, 36 months

  8. Disease progression

    Changes in number of acute exacerbations

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

  9. Disease progression

    Changes in use of supplementary oxygen

    Measured: Baseline, 6 months, 12 months, 24 months, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJun 2021
  4. Study completionJun 2021

Resources

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02818712
Sponsor's protocol ID
IPF: HRQL, comorb and biomark
Status last verified
Nov 2020
First submitted
15 Jun 2016
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Hansen AH, Breisnes HW, Prior TS, Hilberg O, Rasmussen DGK, Genovese F, Lukassen MV, Svensson B, Langholm LL, Manon-Jensen T, Karsdal MA, Leeming DJ, Bendstrup E, Sand JMB. A serologically assessed neo-epitope biomarker of cellular fibronectin degradation is related to pulmonary fibrosis. Clin Biochem. 2023 Aug;118:110599. doi: 10.1016/j.clinbiochem.2023.110599. Epub 2023 Jun 19.

    PubMed 37343745

  • Prior TS, Hoyer N, Hilberg O, Shaker SB, Davidsen JR, Bendstrup E. Responsiveness and minimal clinically important difference of SGRQ-I and K-BILD in idiopathic pulmonary fibrosis. Respir Res. 2020 Apr 21;21(1):91. doi: 10.1186/s12931-020-01359-3.

    PubMed 32316976

  • Prior TS, Hilberg O, Shaker SB, Davidsen JR, Hoyer N, Birring SS, Bendstrup E. Validation of the King's Brief Interstitial Lung Disease questionnaire in Idiopathic Pulmonary Fibrosis. BMC Pulm Med. 2019 Dec 19;19(1):255. doi: 10.1186/s12890-019-1018-0.

    PubMed 31856786

  • Prior TS, Hoyer N, Shaker SB, Davidsen JR, Yorke J, Hilberg O, Bendstrup E. Validation of the IPF-specific version of St. George's Respiratory Questionnaire. Respir Res. 2019 Aug 28;20(1):199. doi: 10.1186/s12931-019-1169-9.

    PubMed 31462235

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by Aarhus University Hospital at 3 sites in Denmark.

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: finished, as of the sponsor's last update on 6 Oct 2021. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Health-related quality of life (time frame: Baseline, 6 months, 12 months, 24 months, 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02818712, which also lists 4 linked publications.

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 6 Oct 2021.

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