Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis (INSIGHTS-IPF)
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ClinicalTrials.gov Identifier: NCT01695408 |
Recruitment Status :
Recruiting
First Posted : September 28, 2012
Last Update Posted : March 11, 2019
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Condition or disease |
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Idiopathic Pulmonary Fibrosis |
INSIGHTS-IPF will report current and comprehensive data on Idiopathic Pulmonary Fibrosis (IPF) in the long-term.
Baseline (cross-sectional part): Description of characteristics of IPF patients in terms of
- key (socio-) demographic data
- IPF risk factors, comorbidities
- methods used for IPF diagnosis
- IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values, biomarkers)
- IPF treatment (detailed information on prescribed drugs and doses; non-pharmacological treatment; listing and score for lung transplantation)
- assessment of patient-related outcomes (PRO) such as quality of life
Follow-up (prospectively up to at least 2 years after inclusion):
- Clinical course of IPF (e.g. in terms of symptoms, lung function, exercise capacity if available)
- Documentation of treatment pathways (switch/add-on/discontinuation of medication), and of non-pharmacological treatment (e.g. start of long term oxygen therapy; new listing for lung transplantation)Outcomes/events (such as acute respiratory worsening, exacerbations, hospitalisation due to any cause and due to IPF, other complications, survival)
- Patient-related outcomes such as quality of life, assessed once a year(for comparison with baseline)
- Resource use for pharmacoeconomic analyses.
Study Type : | Observational |
Estimated Enrollment : | 1100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry. |
Actual Study Start Date : | October 2012 |
Estimated Primary Completion Date : | April 2020 |
Estimated Study Completion Date : | September 2020 |

- Clinical course of IPF (in terms of symptoms, lung function, survival) [ Time Frame: up to 5 years after inclusion ]
- Characteristics of patients with IPF [ Time Frame: up to 5 years after inclusion ]
- Treatment pathways [ Time Frame: up to 5 years after inclusion ]
- Functionality and quality of life [ Time Frame: up to 5 years after inclusion ]St. Georges Respiratory Questionnaire; University of California Shortness of Breath Questionnaire; EuroQuol 5 dimensions

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- At least 18 years of age
- Written informed consent for participation in the registry
- Newly diagnosed (incident) or known (prevalent) IPF (based on diagnosis of treating physician)
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695408
Contact: Juergen Behr, MD | 089 85791 ext 4101 | j.behr@asklepios.com | |
Contact: David Pittrow, MD, PhD | +49 351 25933 ext 182 | david.pittrow@mailbox.tu-dresden.de |
Germany | |
Institute for Clinical Pharmacology, Medical Faculty, Technical University | Active, not recruiting |
Dresden, Germany, 01307 | |
Klinik für Pneumologie, Medizinische Hochschule Hannover | Recruiting |
Hannover, Germany | |
Contact: Antje Prasse, MD +49511 532 ext 3934 pneumologie@mh-hannover.de | |
Principal Investigator: Antje Prasse, MD | |
Pneumologie und Beatmungsmedizin, Thoraxklinik,Universitätsklinikum | Recruiting |
Heidelberg, Germany, 69126 | |
Contact: Michael Kreuter, MD +496221396 ext 1214 michael.kreuter@thoraxklinik-heidelberg.de | |
Principal Investigator: Michael Kreuter, MD | |
Abteilung für Pneumologie Department Innere Medizin, Neurologie und Dermatologie Universitätsklinikum Leipzig AöR | Recruiting |
Leipzig, Germany | |
Contact: Hubert Wirtz, MD hubert.wirtz@medizin.uni-leipzig.de | |
Principal Investigator: Hubert Wirtz, MD | |
V. Med. Clinic, Ludwig-Maximilians-Unviversity | Recruiting |
München, Germany | |
Contact: Jürgen Behr, MD |
Principal Investigator: | Juergen Behr, MD | Asklepios Fachkliniken München Gauting Medizinischen Klinik und Poliklinik V Klinikum der Ludwig-Maximilians-Universität München Comprehensive Pneumology Center Munich (CPC-M) Mitglied des Deutschen Zentrums für Lungenforschung (DZL) | |
Study Chair: | David Pittrow, MD | Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden |
Publications of Results:
Other Publications:
Responsible Party: | Technische Universität Dresden |
ClinicalTrials.gov Identifier: | NCT01695408 |
Other Study ID Numbers: |
INSIGHTS-IPF |
First Posted: | September 28, 2012 Key Record Dates |
Last Update Posted: | March 11, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Drug Treatment Treatment pathways Clinical routine Registry Outcomes Survival Patient-related outcomes Quality of life Steroids |
Azathioprine N-Acetylcysteine Pirfenidone Tyrosine kinase inhibitors Nintedanib multicenter Germany Safety Adverse event |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |