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

NCT ID: NCT03261037

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-25
• Study Completion Date: 2019-11-27

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Participants With Suspicion of IPF/ILD

A participant will be eligible for inclusion if the Investigator has a suspicion that the participant may have IPF/ILD based on symptoms and radiological evidence.

Group Type: OTHER

Spirometry

Intervention Type: OTHER

Daily spirometry will be conducted by the participant at home using the study kit provided. Spirometry assessments (FVC) will be conducted at approximately the same time each day with the participant in a seated position. Additionally, site spirometry will also be performed during pre-diagnosis assessment period, on the day of diagnosis, post-diagnosis assessment period, and at end of study.

Accelerometry

Intervention Type: OTHER

Daily physical functional capacity assessments (e.g., steps per day, calorie expenditure) will be measured on an ongoing basis using the accelerometry device provided.

6MWT

Intervention Type: OTHER

The 6MWT will be performed only at sites where a formalized process is available and the test can be performed under safe conditions, during pre-diagnosis assessment period, on the day of diagnosis, post-diagnosis assessment period, and at end of study.

Interventions

Spirometry

Daily spirometry will be conducted by the participant at home using the study kit provided. Spirometry assessments (FVC) will be conducted at approximately the same time each day with the participant in a seated position. Additionally, site spirometry will also be performed during pre-diagnosis assessment period, on the day of diagnosis, post-diagnosis assessment period, and at end of study.

Intervention Type: OTHER

Accelerometry

Daily physical functional capacity assessments (e.g., steps per day, calorie expenditure) will be measured on an ongoing basis using the accelerometry device provided.

Intervention Type: OTHER

6MWT

The 6MWT will be performed only at sites where a formalized process is available and the test can be performed under safe conditions, during pre-diagnosis assessment period, on the day of diagnosis, post-diagnosis assessment period, and at end of study.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

St. Clare'S Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Kingston Health Sciences Centre; research Kingston General Health Research Institute

Kingston, Ontario, Canada

Dr. Syed Anees Medicine Profession Corporation

Windsor, Ontario, Canada

Clinique de pneumologie et du sommeil de Lanaudiere

Saint-Charles-Borromée, Quebec, Canada

Hopital Louis Pradel; Pneumologie

Bron, , France

Hopital Cote De Nacre; Pneumologie

Caen, , France

Ch De Granville; Pneumologie

Granville, , France

Hopital Calmette; Pneumologie

Lille, , France

Hopital Arnaud De Villeneuve; Pneumologie A

Montpellier, , France

Hopital Tenon;Pneumologie

Paris, , France

Centre Pneumologie Et Allergie

Perpignan, , France

Hopital de Pontchaillou; Service de Pneumologie

Rennes, , France

Ch Bretagne Atlantique; Pneumologie-Oncologie

Vannes, , France

Cork University Hospital

Cork, , Ireland

St James's Hospital

Dublin, , Ireland

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

Chieti, Abruzzo, Italy

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

Napoli, Campania, Italy

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

Modena, Emilia-Romagna, Italy

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

Rome, Lazio, Italy

Az. Osp.Univ.San Martino; Pneumologia

Genoa, Liguria, Italy

ASST Rhodense; U.O.C. Pneumologia

Garbagnate Milanese (MI), Lombardy, Italy

Ospedale Policlinico S. Matteo; S.C. Pneumologia

Pavia, Lombardy, Italy

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

Orbassano (TO), Piedmont, Italy

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

Sassari, Sardinia, Italy

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

Palermo, Sicily, Italy

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

Macerata, The Marches, Italy

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

Florence, Tuscany, Italy

Admiraal de Ruijter Ziekenhuis

Goes, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Isala

Zwolle, , Netherlands

Pulmonologii NII FMBA of Russia

Moscow, Moscow Oblast, Russia

SBI at Rostov Region "Regional Clinical Hospital #2"

Rostov-on-Don, Rostov Oblast, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

SBIH "Chelyabinsk Regional Clinical Hospital"

Chelyabinsk, Sverdlovsk Oblast, Russia

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

Kemerovo, , Russia

SBIH at Vladimir Region "Regional Clinical Hospital"

Vladimir, , Russia

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

Voronezh, , Russia

Countries

Canada; France; Ireland; Italy; Netherlands; Russia

References

Wijsenbeek MS, Bendstrup E, Valenzuela C, Henry MT, Moor CC, Jouneau S, Fois AG, Moran-Mendoza O, Anees S, Mirt M, Bengus M, Gilberg F, Kirchgaessler KU, Vancheri C. Disease Behaviour During the Peri-Diagnostic Period in Patients with Suspected Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2021 Jul;38(7):4040-4056. doi: 10.1007/s12325-021-01790-y. Epub 2021 Jun 11.

Reference Type: DERIVED

PMID: 34117601 (View on PubMed)

Wijsenbeek M, Bendstrup E, Valenzuela C, Henry MT, Moor C, Bengus M, Perjesi A, Gilberg F, Kirchgaessler KU, Vancheri C. Design of a Study Assessing Disease Behaviour During the Peri-Diagnostic Period in Patients with Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2019 Jan;36(1):232-243. doi: 10.1007/s12325-018-0845-3. Epub 2018 Nov 30.

Reference Type: DERIVED

PMID: 30506309 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-005114-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MA39297

Identifier Type: -

Identifier Source: org_study_id