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

NCT03261037 | Completed Results

• 2 other identifiers: MA392972016-005114-22
• Study Type: interventional
• Target: 178
• Locations: 6 countries
• Sites: 37

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

Outcome Measures

Primary Outcomes (1)

• Time-Adjusted Semi-Annual Forced Vital Capacity (FVC) Decline in Participants With IPF During the Peri-Diagnostic Period, Measured in Milliliters (mL) by Daily Home Spirometry

  Minimum site visits were: baseline, diagnosis, and EOS for each participant. From inclusion into the study, participants were followed for up to12 months. The EOS was defined as: If no diagnosis was made 12 months after inclusion, the participant left the study; Participants diagnosed with non-ILD left the study on the date of diagnosis; Participants diagnosed with IPF or non-IPF ILD were followed up to the start of drug treatment (within 6 months) or up to 6 months if no drug treatment was prescribed. Therefore, the total length of the study was variable for each participant. Measurements were taken daily by home spirometry. The semi-annual mean FVC decline was calculated by use of the estimated semi-annual FVC decline of each individual participant. The individual FVC decline was estimated by applying a linear regression model to all acceptable FVC measurements flagged as 'Good blow' collected by the individual participant during the entire peri-diagnostic period (up to 18 months).

  From Day 1 into the study to end of the study (up to 18 months) and adjusted for 6 months. There was no fixed visit schedule for the whole study and reported results comprise all data points from enrollment to EOS

Secondary Outcomes (21)

• Time-Adjusted Semi-Annual FVC Decline in Participants With Non-IPF ILD During the Peri-Diagnostic Period, Measured in mL by Daily Home Spirometry

  From Day 1 into the study to end of the study (up to 18 months) and adjusted for 6 months. There was no fixed visit schedule for the whole study and reported results comprise all data points from enrollment to EOS

• Change From Baseline in the FVC Decline in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured in mL by Site Spirometry

  From Baseline to end of the study (up to 18 months)

• Change From Baseline in the Percent Predicted FVC in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Site Spirometry

  From Baseline to end of the study (up to 18 months)

• Change From Baseline in Distance Walked (Meters) on the 6MWT in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Assessed at Site

  From Baseline to end of the study (up to 18 months)

• Decline in Physical Function Capacity (Steps/Day) in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry

  From inclusion into the study to end of the study (up to 18 months)

Study Arms (1)

Participants With Suspicion of IPF/ILD

OTHER

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.

Other: Spirometry; Other: Accelerometry; Other: 6MWT

Interventions

Spirometry 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.

Participants With Suspicion of IPF/ILD

Accelerometry 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.

Participants With Suspicion of IPF/ILD

6MWT 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.

Participants With Suspicion of IPF/ILD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (37)

St. Clare'S Mercy Hospital

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

Location

Kingston Health Sciences Centre; research Kingston General Health Research Institute

Kingston, Ontario, K7L 5G2, Canada

Location

Dr. Syed Anees Medicine Profession Corporation

Windsor, Ontario, N8X 1T3, Canada

Location

Clinique de pneumologie et du sommeil de Lanaudiere

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

Hopital Louis Pradel; Pneumologie

Bron, 69677, France

Location

Hopital Cote De Nacre; Pneumologie

Caen, 14000, France

Location

Ch De Granville; Pneumologie

Granville, 50406, France

Location

Hopital Calmette; Pneumologie

Lille, 59037, France

Location

Hopital Arnaud De Villeneuve; Pneumologie A

Montpellier, 34295, France

Location

Hopital Tenon;Pneumologie

Paris, 75970, France

Location

Centre Pneumologie Et Allergie

Perpignan, 66025, France

Location

Hopital de Pontchaillou; Service de Pneumologie

Rennes, 35033, France

Location

Ch Bretagne Atlantique; Pneumologie-Oncologie

Vannes, 56017, France

Location

Cork University Hospital

Cork, Ireland

Location

St James's Hospital

Dublin, 8, Ireland

Location

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

Chieti, Abruzzo, 66100, Italy

Location

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

Napoli, Campania, 80131, Italy

Location

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

Modena, Emilia-Romagna, 41124, Italy

Location

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

Rome, Lazio, 00168, Italy

Location

Az. Osp.Univ.San Martino; Pneumologia

Genoa, Liguria, 16132, Italy

Location

ASST Rhodense; U.O.C. Pneumologia

Garbagnate Milanese (MI), Lombardy, 20024, Italy

Location

Ospedale Policlinico S. Matteo; S.C. Pneumologia

Pavia, Lombardy, 27100, Italy

Location

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

Orbassano (TO), Piedmont, 10043, Italy

Location

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

Sassari, Sardinia, 07100, Italy

Location

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

Palermo, Sicily, 90127, Italy

Location

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

Macerata, The Marches, 62100, Italy

Location

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

Florence, Tuscany, 50134, Italy

Location

Admiraal de Ruijter Ziekenhuis

Goes, 4462 RA, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3000 CA, Netherlands

Location

Isala

Zwolle, 8025 AB, Netherlands

Location

Pulmonologii NII FMBA of Russia

Moscow, Moscow Oblast, Russia

Location

SBI at Rostov Region "Regional Clinical Hospital #2"

Rostov-on-Don, Rostov Oblast, 344029, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

SBIH "Chelyabinsk Regional Clinical Hospital"

Chelyabinsk, Sverdlovsk Oblast, 454076, Russia

Location

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

Kemerovo, 650099, Russia

Location

SBIH at Vladimir Region "Regional Clinical Hospital"

Vladimir, 600023, Russia

Location

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

Voronezh, 394066, Russia

Location

Related Publications (2)

• 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.

  PMID: 34117601 DERIVED

• 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.

  PMID: 30506309 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Interventions

Accelerometry

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: December 25, 2017
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: March 26, 2021
• Results First Posted: March 26, 2021

Record last verified: 2021-03

Locations

IT (12); CA (4); NL (3); IE (2); RU (7); FR (9)