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Idiopathic Pulmonary FibrosisNCT02622477

Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)

An observational study of Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 17 sites in Germany.

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

The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet® (Pirfenidone). Read more about this study

Who is it for?
Any age
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Pirfenidone
Type of treatment
Pill or oral medicine
How many people
12 participants
Where
17 sitesGermany
Study dates
Jun 2014to Dec 2016
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adult patients with diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF), who had previously not yet been treated with Pirfenidone

Who may be able to join

  • Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet been treated with Pirfenidone

Who cannot join

  • Hypersensitivity to the active substance or one of the other excipients of Pirfenidone Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe renal impairment (Creatinine-Clearance <30 ml/min) or end stage renal disease requiring dialysis Simultaneous participation in interventional studies Previously treated with Pirfenidone for longer than 30 days

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Germany17 sites

  • Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert

    Aschaffenburg, 63739

  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    Berlin, 13125

  • Dr. med. Martin Hoster, Dr. Hans-G. Lange von Stocmeier, Michael Behn und w.

    Bochum, 44787

  • Praxis Dr. med. Wilhelm Ammenwerth

    Bochum, 44787

  • Augusta Kranken-Anstalt gGmbH

    Bochum, 44791

  • Kliniken der Stadt Köln gGmbH Krankenhaus Merheim

    Cologne, 51109

  • Fachkrankenhaus Coswig GmbH

    Coswig, 01640

  • Klinikum Werra-Meißner GmbH

    Eschwege, 37269

  • Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

    Essen, 45239

  • Universitätsklinikum Freiburg, Abteilung Pneumologie

    Freiburg im Breisgau, 79106

  • Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda

    Fulda, 36043

  • Ev. Krankenhaus Göttingen-Weende E.V.

    Göttingen, 37075

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

    Halle, 06120

  • Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie

    Magdeburg, 39120

  • Thoraxzentrum, Abt. Pneumologie

    Münnerstadt

  • Praxis Dr. med. Matthias Waltert

    Münster, 48145

  • Facharztzentrum üBAG

    Sonneberg, 96515

Other trials in Germany

About this study

Official title: Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF

The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).

Being tested
Pirfenidone
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.

  • PirfenidoneDrug

    This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.

Study groups in NCT02622477
Study groupRoleWhat they receive
Participants with idiopathic pulmonary fibrosisParticipants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses.
Receives: Drug: Pirfenidone

What is being measured

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

  1. Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment

    Measured: -3 to 8 months before inclusion, appointment 0, and 3, 6, 9 and 12 months after appointment

  2. Categorical Decrease of the 6-Minute Walking Distance (>= 50 Metres Compared to the Previous Examination Findings) Under Treatment

    Measured: Appointment 0, and 3, 6, 9 and 12 months after appointment 0

  3. Disease Progression

    Measured: Appointment 0, and 3, 6, 9 and 12 months after appointment 0

Secondary outcomes (10)

  1. Progression of the LCQ (Leicester Cough Questionnaire)

    Measured: Appointment 0, and 3, 6, 9 and 12 months after appointment 0

  2. Progression of the SOBQ (Shortness of Breath Questionnaire)

    Measured: Appointment 0, and 3, 6, 9 and 12 months after appointment 0

  3. Proportion of the Participants With Exacerbations

    Measured: Appointment 0, and 3, 6, 9 and 12 months after appointment 0

  4. Cases Of Death (All, Idiopathic Pulmonary Fibrosis Associated)

    Measured: Up to 12 months

  5. Proportion of the Participants, who After the 3 Week Titration Phase Receive the Full Maintenance Dosage Of Pirfenidone

    Measured: 3, 6, 9 and 12 months after appointment 0

  6. Dosage of Pirfenidone

    Measured: Up to 12 months

  7. Proportion of the Participants who Change the Dosage Of Pirfenidone

    Measured: Up to 12 months

  8. Reasons for the Dosage Change

    Measured: Up to 12 months

  9. Reasons for the Beginning, Change or Discontinuation of a Treatment of Comorbidities of Pirfenidone Associated Adverse Drug Reactions

    Measured: Up to 12 months

  10. Number of Participants With at Least one Adverse Drug Reaction Under the Therapy With Pirfenidone

    Measured: Up to 12 months

Timeline

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

  1. First posted4 Dec 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Cross-sectional
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02622477
Sponsor's protocol ID
ML30016
Status last verified
Feb 2017
First submitted
2 Dec 2015
Last updated
28 Feb 2017
Results posted
No
Individual data sharing
Undecided

Publications

  • Schreiber J, Schutte W, Koerber W, Seese B, Koschel D, Neuland K, Grohe C. Clinical course of mild-to-moderate idiopathic pulmonary fibrosis during therapy with pirfenidone: Results of the non-interventional study AERplus. Pneumologie. 2024 Apr;78(4):236-243. doi: 10.1055/a-2267-2074. Epub 2024 Apr 12.

    PubMed 38608658

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 17 sites in Germany.

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 1 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: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany. 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?

Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment (time frame: -3 to 8 months before inclusion, appointment 0, and 3, 6, 9 and 12 months after appointment). The study lists 3 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 NCT02622477, which also lists 1 linked publication.

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 28 Feb 2017.

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