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Explorative Study on the Molecular Pathology of Lung Fibrosis by Combination of Clinical Assessment and System Biology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01687946
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
Rolf Ziesche, Medical University of Vienna

Brief Summary:

RESOLVE's objective is to identify and characterize validated molecular targets capable of shifting primary organ repair towards fibroproliferative wound healing.

Work package 2 (WP2) of RESOLVE includes the clinical study protocols within the RESOLVE system evaluating different forms of pulmonary repair in humans ranging from normal repair over mainly inflammatory to predominantly fibroproliferative repair.


Fibrosis of the lung is an aberrant and intensified form of wound healing. It is the result of an unresolved disturbance of both initiation and control of repair which is partly age-related. As a result of the relentlessly activated wound healing reaction, mechanisms of inflammation largely representing the condition of chronic inflammation within the peripheral bronchial tree will aggravate this abnormal form of repair.

A systematic comparison of the molecular pathology of fibrotic repair representing

  • Varying intensity of fibrosis related to the pathology of usual interstitial pneumonia (UIP),
  • Varying inflammatory mechanisms (UIP vs. Hypersensitivity pneumonitis [HP], acute and chronic), and
  • Varying stages of age (Normal pulmonary repair in young and old individuals vs. acute/chronic HP vs. UIP) will be able to
  • identify molecules capable of shifting regular repair towards fibroproliferative repair and
  • elucidate their interrelationship with other molecules forming coordinated yet misdirected metabolic responses characteristic for fibroproliferative repair.

Condition or disease
Pulmonary Fibrosis

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Investigation on the Combined Use of Established Clinical Criteria and Systems Biology for Progressive Pulmonary Fibrosis
Study Start Date : June 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Pulmonary fibrosis in aged individuals

Group A and B:

Patients with UIP (histologically and/or radiologically proven) providing informed consent. According to functional and radiological assessment, the disease may be either limited (Group A) or advanced (Group B). The patients are usually older than 55 years.

Pulmonary fibrosis and inflammation

Groups C and D:

Patients with HP (histologically and radiologically proven) providing informed consent. According to functional and radiological assessment, the disease will be either acute or chronic. The patients will be significantly younger (mean > 10 years) than in groups A and B.

Regular wound healing in lung
Patients receiving lung biopsy or bronchoscopy for reasons other that the study and volunteers providing informed consent. The group will consist of young (18-40 years) and old individuals (older than 55 years).

Primary Outcome Measures :
  1. Analysis of lung biopsies by system biology techniques. [ Time Frame: Two measurements within 1 year. ]

Biospecimen Retention:   Samples With DNA
Transbronchial biopsies and Video-assisted throracoscopic biopsies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The participants are chosen from patients lists of participating center.

Inclusion criteria:

  • Informed consent
  • Histological and radiological proof of UIP or HP

Exclusion criteria

  • Functionally significant cardiovascular morbidity
  • Respiratory insufficiency (PaO2 < 55 mmHg; PaCO2 > 50 mmHg)
  • Significant pulmonary hypertension
  • Significant pulmonary emphysema
  • Non-functional contralateral lung
  • Cancer
  • Significant coronary heart disease
  • Coagulation dysfunction
  • Pregnancy, or planning pregnancy during the trial or within three month period thereafter
  • Known drug or alcohol abuse within 3 years of screening
  • Presumed non-compliance
  • Known legal incapacity or limited legal capacity at screening

Information from the National Library of Medicine

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 identifier (NCT number): NCT01687946

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Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Study Chair: Lutz H Block, MD Medical University of Vienna
Additional Information:
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Responsible Party: Rolf Ziesche, Associated Professor of Medicine, Medical University of Vienna Identifier: NCT01687946    
Other Study ID Numbers: RESOLVE - WP2
HEALTH-F4-2008-202047 ( Other Grant/Funding Number: EC FP7 Health - Research Grant number HEALTH-F4-2008-202047 )
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rolf Ziesche, Medical University of Vienna:
Biology of Fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases