Clinical trial NCT03261037: A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period
Official title: An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-08-24
Enrollment: 178
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: Time-Adjusted Semi-Annual FVC Decline in Participants With Non-IPF ILD During the Peri-Diagnostic Period, Measured in mL by Daily Home Spirometry
timeFrame: 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
measure: 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
timeFrame: From Baseline to end of the study (up to 18 months)
measure: Change From Baseline in the Percent Predicted FVC in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Site Spirometry
timeFrame: From Baseline to end of the study (up to 18 months)
measure: 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
timeFrame: From Baseline to end of the study (up to 18 months)
measure: Decline in Physical Function Capacity (Steps/Day) in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Calorie Expenditure in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Pearson's Correlation Coefficient of FVC (mL) Between Home and Site Spirometry in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Pearson's Correlation Coefficient of Physical Functional Capacity Assessed at Home in Terms of the Decline in the Number of Footsteps and on Site in Terms of the Decline in Distance of the 6MWT
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Percentage of Participants Requiring Respiratory-Related Hospitalizations
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Percentage of Participants With Non-Elective Hospitalizations
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Percentage of Participants With Investigator-Reported Acute Exacerbations
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Percentage of Participants Who Died Due to Any Cause
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Percentage of Participants Who Died Due to Respiratory-Related Diseases
timeFrame: From inclusion into the study to end of the study (up to 18 months)
measure: Percentage of Participants With Events Related to the Study Assessments
timeFrame: From inclusion into the study to end of the study (up to 18 months)
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: St. Clare'S Mercy Hospital
state: Newfoundland and Labrador
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre; research Kingston General Health Research Institute
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Profession Corporation
state: Ontario
city: Saint-Charles-Borromee
country: Canada
facility: Clinique de pneumologie et du sommeil de Lanaudiere
state: Quebec
city: Bron
country: France
facility: Hopital Louis Pradel; Pneumologie
city: Caen
country: France
facility: Hopital Cote De Nacre; Pneumologie
city: Granville
country: France
facility: Ch De Granville; Pneumologie
city: Lille
country: France
facility: Hopital Calmette; Pneumologie
city: Montpellier
country: France
facility: Hopital Arnaud De Villeneuve; Pneumologie A
city: Paris
country: France
facility: Hopital Tenon;Pneumologie
city: Perpignan
country: France
facility: Centre Pneumologie Et Allergie
city: Rennes
country: France
facility: Hopital de Pontchaillou; Service de Pneumologie
city: Vannes
country: France
facility: Ch Bretagne Atlantique; Pneumologie-Oncologie
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Chieti
country: Italy
facility: P.O. Clinicizz. 'SS. Annunziata'; U.O.C. Pneumologia
state: Abruzzo
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli - P. Monaldi; Dip. Medicina Clinica e Chirurgia
state: Campania
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico A. Gemelli e C.I.C.; Polo Scienze Cardiovascolari e Toraciche - UOC Pneumologia
state: Lazio
city: Genova
country: Italy
facility: Az. Osp.Univ.San Martino; Pneumologia
state: Liguria
city: Garbagnate Milanese (MI)
country: Italy
facility: ASST Rhodense; U.O.C. Pneumologia
state: Lombardia
city: Pavia
country: Italy
facility: Ospedale Policlinico S. Matteo; S.C. Pneumologia
state: Lombardia
city: Macerata
country: Italy
facility: Pres. Osp. Unico ZT9 - Ospedale Generale Provinciale; U.O.C. Pneumologia
state: Marche
city: Orbassano (to)
country: Italy
facility: A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone
state: Piemonte
city: Sassari
country: Italy
facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
state: Sardegna
city: Palermo
country: Italy
facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare
state: Toscana
city: Goes
country: Netherlands
facility: Admiraal de Ruijter Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala
city: Sankt-peterburg
country: Russian Federation
facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
state: Leningrad
city: Moscow
country: Russian Federation
facility: Pulmonologii NII FMBA of Russia
state: Moskovskaja Oblast
city: Rostov-na-donu
country: Russian Federation
facility: SBI at Rostov Region "Regional Clinical Hospital #2"
state: Rostov
city: Chelyabinsk
country: Russian Federation
facility: SBIH "Chelyabinsk Regional Clinical Hospital"
state: Sverdlovsk
city: Kemerovo
country: Russian Federation
facility: Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
city: Vladimir
country: Russian Federation
facility: SBIH at Vladimir Region "Regional Clinical Hospital"
city: Voronezh
country: Russian Federation
facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.