NCT02818712

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 6, 2021

Status Verified

November 1, 2020

Enrollment Period

4.8 years

First QC Date

June 15, 2016

Last Update Submit

October 5, 2021

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (5)

  • Health-related quality of life

    Change in St. George's Respiratory Questionnaire

    Baseline, 6 months, 12 months, 24 months, 36 months

  • Health-related quality of life

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

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

  • Health-related quality of life

    Changes in King's Brief Interstitial Lung Disease questionnaire

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

  • Number and type of comorbidities

    Prevalence of comorbidities at baseline

    Baseline

  • Number and type of comorbidities

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

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

Secondary Outcomes (9)

  • Lung function tests

    Baseline, 6 months, 12 months, 24 months, 36 months

  • Lung function tests

    Baseline, 6 months, 12 months, 24 months, 36 months

  • 6-minute walk test

    Baseline, 6 months, 12 months, 24 months, 36 months

  • Progression in serum/plasma biomarker levels

    Baseline, 6 months, 12 months, 24 months, 36 months

  • Health-related quality of life

    Baseline, 6 months, 12 months, 24 months, 36 months

  • +4 more secondary outcomes

Study Arms (1)

Patients with IPF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Incident and prevalent patients with IPF in Denmark.

You may qualify if:

  • A clinical diagnosis of IPF
  • Signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hosptial

Aarhus C, Denmark

Location

Gentofte Hospital

Hellerup, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 37343745DERIVED

  • 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.

    PMID: 32316976DERIVED

  • 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.

    PMID: 31856786DERIVED

  • 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.

    PMID: 31462235DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and EDTA-plasma is collected from all patients at 0, 6, 12, 24 and 36 months

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 30, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

October 6, 2021

Record last verified: 2020-11

Locations

DK(3)