A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period

Study Purpose

This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Able to comply with the study protocol, in the Investigator's judgment - for example, the ability to use the provided spirometer and tablet and the ability to fill in the required patient reported outcomes questionnaires - Suspicion of IPF/ILD: radiological evidence of IPF/ILD in symptomatic participants (unexplained dyspnea on exertion and/or cough)

Exclusion Criteria:

- Participation in any investigational study within 28 days prior to inclusion - History of clinically significant cardiac disease that could explain the patient's symptomatology in the opinion of the Investigator - Known history of any connective tissue disease, including, but not limited to, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or mixed connective tissue disease

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03261037

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Hoffmann-La Roche

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Canada, France, Ireland, Italy, Netherlands, Russian Federation

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Yaroslavl, Russian Federation

Status

Withdrawn

Address

City Clinical Hospital No. 2; Pulmonology

Yaroslavl, , 150010

Voronezh, Russian Federation

Status

Active, not recruiting

Address

Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

Voronezh, , 394066

Vladimir, Russian Federation

Status

Active, not recruiting

Address

SBIH at Vladimir Region "Regional Clinical Hospital"

Vladimir, , 600023

Kemerovo, Russian Federation

Status

Completed

Address

Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo

Kemerovo, , 650099

Chelyabinsk, Sverdlovsk, Russian Federation

Status

Active, not recruiting

Address

SBIH "Chelyabinsk Regional Clinical Hospital"

Chelyabinsk, Sverdlovsk, 454076

Rostov-na-donu, Rostov, Russian Federation

Status

Completed

Address

SBI at Rostov Region "Regional Clinical Hospital #2"

Rostov-na-donu, Rostov, 344029

Pulmonologii NII FMBA of Russia, Moscow, Moskovskaja Oblast, Russian Federation

Status

Completed

Address

Pulmonologii NII FMBA of Russia

Moscow, Moskovskaja Oblast,

Sankt-peterburg, Leningrad, Russian Federation

Status

Active, not recruiting

Address

SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

Sankt-peterburg, Leningrad, 197022

Isala, Zwolle, Netherlands

Status

Active, not recruiting

Address

Isala

Zwolle, , 8025 AB

Erasmus Medisch Centrum, Rotterdam, Netherlands

Status

Completed

Address

Erasmus Medisch Centrum

Rotterdam, , 3015 GD

Goes, Netherlands

Status

Active, not recruiting

Address

Admiraal de Ruijter Ziekenhuis;Interne Geneeskunde

Goes, , 4462 RA

Firenze, Toscana, Italy

Status

Completed

Address

Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare

Firenze, Toscana, 50134

Palermo, Sicilia, Italy

Status

Active, not recruiting

Address

Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

Palermo, Sicilia, 90127

Sassari, Sardegna, Italy

Status

Active, not recruiting

Address

A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

Sassari, Sardegna, 07100

Orbassano (to), Piemonte, Italy

Status

Active, not recruiting

Address

A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone

Orbassano (to), Piemonte, 10043

Macerata, Marche, Italy

Status

Active, not recruiting

Address

Pres. Osp. Unico ZT9 - Ospedale Generale Provinciale; U.O.C. Pneumologia

Macerata, Marche, 62100

Pavia, Lombardia, Italy

Status

Recruiting

Address

Ospedale Policlinico S. Matteo; S.C. Pneumologia

Pavia, Lombardia, 27100

ASST Rhodense; U.O.C. Pneumologia, Garbagnate Milanese (MI), Lombardia, Italy

Status

Active, not recruiting

Address

ASST Rhodense; U.O.C. Pneumologia

Garbagnate Milanese (MI), Lombardia, 20024

Az. Osp.Univ.San Martino; Pneumologia, Genova, Liguria, Italy

Status

Active, not recruiting

Address

Az. Osp.Univ.San Martino; Pneumologia

Genova, Liguria, 16132

Roma, Lazio, Italy

Status

Completed

Address

Policlinico A. Gemelli e C.I.C.; Polo Scienze Cardiovascolari e Toraciche - UOC Pneumologia

Roma, Lazio, 00168

Modena, Emilia-Romagna, Italy

Status

Active, not recruiting

Address

A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio

Modena, Emilia-Romagna, 41124

Napoli, Campania, Italy

Status

Active, not recruiting

Address

Azienda Ospedaliera dei Colli - P. Monaldi; Dip. Medicina Clinica e Chirurgia

Napoli, Campania, 80131

Chieti, Abruzzo, Italy

Status

Completed

Address

P.O. Clinicizz. 'SS. Annunziata'; U.O.C. Pneumologia

Chieti, Abruzzo, 66100

St James's Hospital, Dublin, Ireland

Status

Recruiting

Address

St James's Hospital

Dublin, , 8

Cork University Hospital, Cork, Ireland

Status

Recruiting

Address

Cork University Hospital

Cork, ,

Vannes, France

Status

Active, not recruiting

Address

Ch Bretagne Atlantique; Pneumologie-Oncologie

Vannes, , 56017

Rennes, France

Status

Active, not recruiting

Address

Hopital de Pontchaillou; Service de Pneumologie

Rennes, , 35033

Centre Pneumologie Et Allergie, Perpignan, France

Status

Active, not recruiting

Address

Centre Pneumologie Et Allergie

Perpignan, , 66025

Hopital Tenon;Pneumologie, Paris, France

Status

Active, not recruiting

Address

Hopital Tenon;Pneumologie

Paris, , 75970

Montpellier, France

Status

Active, not recruiting

Address

Hopital Arnaud De Villeneuve; Pneumologie A

Montpellier, , 34295

Centre Hospitalier; Pneumologie, Metz Tessy, France

Status

Active, not recruiting

Address

Centre Hospitalier; Pneumologie

Metz Tessy, , 74370

Hopital Calmette; Pneumologie, Lille, France

Status

Active, not recruiting

Address

Hopital Calmette; Pneumologie

Lille, , 59037

Ch De Granville; Pneumologie, Granville, France

Status

Recruiting

Address

Ch De Granville; Pneumologie

Granville, , 50406

Creteil, France

Status

Active, not recruiting

Address

Centre Hospitalier Intercommunal; Service de Pneumologie

Creteil, , 94010

Hopital Cote De Nacre; Pneumologie, Caen, France

Status

Active, not recruiting

Address

Hopital Cote De Nacre; Pneumologie

Caen, , 14000

Hopital Louis Pradel; Pneumologie, Bron, France

Status

Active, not recruiting

Address

Hopital Louis Pradel; Pneumologie

Bron, , 69677

Saint-Charles-Borromee, Quebec, Canada

Status

Active, not recruiting

Address

Clinique de pneumologie et du sommeil de Lanaudiere

Saint-Charles-Borromee, Quebec, J6E 2B4

Windsor, Ontario, Canada

Status

Active, not recruiting

Address

Dr. Syed Anees Medicine Profession Corporation

Windsor, Ontario, N8X 1T3

Kingston, Ontario, Canada

Status

Active, not recruiting

Address

Hotel Dieu Hospital; Queen's University; Department of Medicine

Kingston, Ontario, K7L 5G2

St. Clare'S Mercy Hospital, St. John's, Newfoundland and Labrador, Canada

Status

Active, not recruiting

Address

St. Clare'S Mercy Hospital

St. John's, Newfoundland and Labrador, A1B 3V6

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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