Idiopathic Pulmonary FibrosisNCT03386994

OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study

An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 31 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Descriptive prospective non-interventional multicenter study based on newly collected data of Idiopathic Pulmonary Fibrosis patients followed-up for one year in secondary care settings (Pulmonology Services) Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Idiopathic Pulmonary Fibrosis
How many people: 204 participants
Where: 31 sitesSpain
Study dates: 29 Nov 2017to 16 Sep 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: It is planned that data of approximately 200 patients from approximately 25 sites (secondary care sites - Pulmonology services where IPF is diagnosed and managed) in Spain will be collected. All Idiopathic Pulmonary Fibrosis patients who are diagnosed with IPF and attend to a routine visit during the inclusion period and fulfill inclusion/exclusion criteria and provide informed consent to participate will be included in the study.

Who may be able to join

Female and male patients ≥ 40 years of age
Patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to last ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management consensus
Written informed consent prior to participation

Who cannot join

Inability for the patient to understand or complete the written Inform Consent or patients questionnaires or to understand Spanish
Current participation in any clinical trial
Patients for whom further follow-up is not possible at the enrolling site

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

Spain31 sites

Hospital General Universitario de Alicante
Alicante, 03010
Hospital Infanta Cristina
Badajoz, 06080
Hospital Universitario Cruces
Barakaldo (Vizcaya), 48903
H. del Mar
Barcelona, 8003
H. U. Vall d'Hebron
Barcelona, 8035
H. U. de Bellvitge
Barcelona, 8907
H. U. Germans Trias i Pujol
Barcelona, 8916
Hospital Universitario de Burgos
Burgos, 09006
Hospital General Universitario Santa Lucía
Cartagena (Murcia), 30202
Hospital General Universitario de Castellón
Castellon, 12004
H. U. de Girona Doctor Josep Trueta
Girona, 17007
Hospital Universitario Virgen de las Nieves
Granada, 18014
Can Misses
Ibiza Town, 7800
Hospital Universitario Lucus Augusti
Lugo, 27003
H. Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario Puerta de Hierro
Majadahonda (Madrid), 28222
Hospital Regional Universitario de Málaga
Málaga, 29010
H. Son Llatzer
Mallorca, 7198
H. de Manacor
Mallorca, 7500
Hospital Costa del Sol
Marbella (Málaga), 29603
H. Mateu Orfila
Menorca, 7703
Hospital Montecelo
Mourente (Pontevedra), 36071
CHU de Ourense
Ourense, 32005
H. Central de Asturias
Oviedo, 33011
Hospital Universitari Son Espases
Palma de Mallorca, 07020
Hospital Universitario Donostia
San Sebastián, 20014
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706
Hospital Sierrallana y Tres Mares
Torrelavega (Cantabria), 39300
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Hospital Miguel Servet
Zaragoza, 50009

Other trials in Spain

About this study

Official title: Observational Analysis on the Socio-economic Impact of IPF in Spain

Conditions: Idiopathic Pulmonary Fibrosis
Medical subject headings: Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03386994
Study group	Role	What they receive
Idiopathic Pulmonary Fibrosis patients		all IPF patients

What is being measured

The primary outcome is the main question the study is designed to answer.

Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
The total annual IPF-related costs were obtained as the sum of direct health costs, direct non-health costs and indirect costs. IPF-related costs were quantified for each patient over the follow-up period of 12 months. The direct health and direct non-health costs were calculated as the sum of the costs of medical visits, emergency room visits, hospital admissions, outpatient tests, non-pharmacological treatments and pharmacological treatments and the sum of transport costs, paid caregivers costs, orthopedic material costs, financial aid, and structural changes cost. The indirect costs included number of IPF related days off work and time dedicated to patient care with IPF (informal caregiver). The opportunity cost method was used to calculate informal care costs. The indirect costs were estimated by applying salary costs based on the latest data published by the Spanish Instituto Nacional de Estadística from the salary structure survey, adjusted to age.
Measured: 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).

Secondary outcomes (18)

Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)
The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value, is assessed through SGRQ. The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). The number of participants analysed displays the number of participants with available data at the timepoint of interests.
Measured: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)
The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the EQ-VAS, which is a self-rated health status using a visual analogue scale (VAS), ranging form 0-100, with 0 = worst state of health imaginable and 100 = best state of health imaginable. The EQ-VAS is part of the EuroQoL five dimensions questionaire 5L (EQ-5D-5L).
The number of participants analysed displays the number of participants with available data at the timepoint of interests.
Measured: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index
The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the Barthel Index.
Barthel Index were used to score the ability of a participant to care for himself. It consists of 10 items, the values assigned to each item are based on time and amount of actual physical assistance required if a participant is unable to perform the activity. The final score ranges from 0 and 100. Participant scoring 100 is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs.
The number of participants analysed displays the number of participants with available data at the timepoint of interests.
Measured: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year
Number of IPF-patients with acute exacerbations according to Forced Vital Capacity (FVC)% that occured along one year.
Acute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality.
Measured: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Total Annual Acute Exacerbation-related Costs
The total annual acute exacerbation-related costs were obtained as the sum of direct and indirect costs for each patient over the follow-up period of 12 months.
For estimation of costs the following variables were used: Acute exacerbation related resource use for direct cost estimation: primary and secondary care visits, emergency visits (primary care and hospital), hospitalizations, ICU with and without intubation (qualitative analysis), outpatient tests and other examinations, use of transport, use of formal caregiver, pharmacological and non-pharmacological treatments (except treatments administered in hospitalization), orthopedic material, formal social services, economic aid and structural adaptations. Acute exacerbation related resource use for indirect cost estimation: patients' days off work and informal caregiver.
Measured: 12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%.
FVC decline is calculated: FVC% (T12)- FVC%(T0)).
In order to estimate the direct and indirect costs according to FVC decline the following variable were described:
FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253)
(FVC is FVC in liters, T is height in cm and E is age in years)
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5%
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%.
FVC decline is calculated: FVC% (T12)- FVC%(T0)).
In order to estimate the direct and indirect costs according to FVC decline the following variable were described:
FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253)
(FVC is FVC in liters, T is height in cm and E is age in years)
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5%
Results are reported for participants with predicted FVC <50% at baseline.
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%.
FVC decline is calculated: FVC% (T12)- FVC%(T0)).
In order to estimate the direct and indirect costs according to FVC decline the following variable were described:
Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253)
(FVC is FVC in liters, T is height in cm and E is age in years)
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5%
Results are reported for participants with predicted FVC 50-80% at baseline.
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%.
FVC decline is calculated: FVC% (T12)- FVC%(T0)).
In order to estimate the direct and indirect costs according to FVC decline the following variable were described:
Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253)
(FVC is FVC in liters, T is height in cm and E is age in years)
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5%
Results are reported for participants with predicted FVC > 80% at baseline.
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).
The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life).
FVC decline: FVC% (T12)- FVC%(T0)
In order to estimate the Quality of Life according to FVC decline the following variable were described:
FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253)
(FVC is FVC in liters, T is height in cm and E is age in years).
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5%
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).
The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life).
FVC decline: FVC% (T12)- FVC%(T0)
In order to estimate SGRQ according to FVC decline the following variable were described:
Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253)
(FVC is FVC in liters, T is height in cm and E is age in years).
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5%
Results are reported for participants with predicted FVC<50% at baseline.
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).
The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life).
FVC decline: FVC% (T12)- FVC%(T0)
Results are reported for participants with predicted FVC 50-80% at baseline.
Measured: 12 months (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).
The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life).
FVC decline: FVC% (T12)- FVC%(T0)
Results are reported for participants with predicted FVC >80% at baseline.
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Overall FVC Patient Group
Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health.
FVC decline: FVC% (T12)- FVC%(T0)
In order to estimate the EQ-VAS according to FVC decline the following variable were described:
FVC % predicted along the study:
Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253)
(FVC is FVC in liters, T is height in cm and E is age in years)
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5%
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).
The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health.
FVC decline: FVC% (T12)- FVC%(T0)
In order to estimate the EQ-VAS according to FVC decline the following variable were described:
FVC % predicted along the study:
Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC<50% at baseline.
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Subgroup: Predicted FVC 50-80% at T0
Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).
The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health.
FVC decline: FVC% (T12)- FVC%(T0)
In order to estimate the EQ-VAS according to FVC decline the following variable were described:
FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC 50-80% at baseline.
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).
The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health.
FVC decline: FVC% (T12)- FVC%(T0)
In order to estimate the EQ-VAS according to FVC decline the following variable were described:
FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)
The calculated variable was stratified into the following subgroups between T0 and T12:
≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC>80% at baseline.
Measured: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire
Caregivers of IPF patients were asked to complete the Zarit Burden Interview. It is a self-report measure. The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options, in the Spanish version, range from 0 (never) to 4 (nearly always).
The final score ranges from 0 to 88. A higher score implies a greater burden (≤ 21: Little or no burden; 22-40: mild to moderate burden; 41-60: moderate to severe burden; ≥ 61: severe burden).
Measured: 12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 201716 Sep 2019

First posted29 Dec 2017
Study start29 Nov 2017
Primary completion16 Sep 2019
Study completion16 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03386994
Sponsor's protocol ID: 1199-0296
Status last verified: Oct 2020
First submitted: 16 Nov 2017
Last updated: 9 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Analysis on the Socio-economic Impact of IPF in Spain
ClinicalTrials.gov ID: NCT03386994
Acronym / sponsor ID: 1199-0296
Conditions: Idiopathic Pulmonary Fibrosis
Study type: Observational
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 29 Nov 2017 (actual)
Primary completion: 16 Sep 2019 (actual)
Study completion: 16 Sep 2019 (actual)
First posted: 29 Dec 2017 (actual)
Results: Posted 5 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Idiopathic Pulmonary Fibrosis patients	–	–all IPF patients

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: It is planned that data of approximately 200 patients from approximately 25 sites (secondary care sites - Pulmonology services where IPF is diagnosed and managed) in Spain will be collected. All Idiopathic Pulmonary Fibrosis patients who are diagnosed with IPF and attend to a routine visit during the inclusion period and fulfill inclusion/exclusion criteria and provide informed consent to participate will be included in the study.

Key inclusion criteria (3 listed)

Female and male patients ≥ 40 years of age
Patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to last ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management consensus
Written informed consent prior to participation

Key exclusion criteria (3 listed)

Inability for the patient to understand or complete the written Inform Consent or patients questionnaires or to understand Spanish
Current participation in any clinical trial
Patients for whom further follow-up is not possible at the enrolling site

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
Time frame: 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).
The total annual IPF-related costs were obtained as the sum of direct health costs, direct non-health costs and indirect costs. IPF-related costs were quantified for each patient over the follow-up period of 12 months. The direct health and direct non-health costs were calculated as the sum of the costs of medical visits, emergency room visits, hospital admissions, outpatient tests, non-pharmacological treatments and pharmacological treatments and the sum of transport costs, paid caregivers costs, orthopedic material costs, financial aid, and structural changes cost. The indirect costs included number of IPF related days off work and time dedicated to patient care with IPF (informal caregiver). The opportunity cost method was used to calculate informal care costs. The indirect costs were estimated by applying salary costs based on the latest data published by the Spanish Instituto Nacional de Estadística from the salary structure survey, adjusted to age.

18 secondary outcomes

Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)
Time frame: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)
Time frame: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index
Time frame: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year
Time frame: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Total Annual Acute Exacerbation-related Costs
Time frame: 12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
Time frame: 12 months (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Overall FVC Patient Group
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Subgroup: Predicted FVC 50-80% at T0
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Time frame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire
Time frame: 12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).

Results and safety

Results posted to the registry on 5 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients With IPF - Overall Population	204	166

Primary outcome: Idiopathic Pulmonary Fibrosis (IPF)-Related Costs

Time frame: 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).. Mean (Standard Deviation). Unit: Euro (€)

Measure	IPF Patients With Predicted FVC <50% at T0 - Subgroup n = 15	IPF Patients With Predicted FVC 50-80% at T0 - Subgroup n = 152	IPF Patients With Predicted FVC >80% at T0 - Subgroup n = 25
Total annual IPF related costs	38923.57 (29263.42)	22613.68 (12873.07)	20369.94 (11955.91)
Annual direct health IPF-related costs	37183.17 (28465.86)	22425.64 (12788.42)	20195.31 (12159.89)
Annual direct non-health related costs	1657.63 (3148.58)	149.25 (701.58)	174.63 (589.53)
Annual indirect IPF-related costs	82.77 (320.58)	38.79 (316.50)	0.00 (0.00)

IPF Patients With Predicted FVC <50% at T0 - Subgroup vs IPF Patients With Predicted FVC 50-80% at T0 - Subgroup vs IPF Patients With Predicted FVC >80% at T0 - Subgroup: p = 0.0002, ANOVA
IPF Patients With Predicted FVC <50% at T0 - Subgroup vs IPF Patients With Predicted FVC 50-80% at T0 - Subgroup vs IPF Patients With Predicted FVC >80% at T0 - Subgroup: p = 0.0007, ANOVA
IPF Patients With Predicted FVC <50% at T0 - Subgroup vs IPF Patients With Predicted FVC 50-80% at T0 - Subgroup vs IPF Patients With Predicted FVC >80% at T0 - Subgroup: p <0.0001, ANOVA

Population analysed: Evaluable Population (cost): Evaluable Population who had data on resource use due to IPF (primary/secondary care/emergency visits, transport, hospitalization, outpatient tests, (non)-pharmacological treatment, caregivers, orthopedic material, structural changes, economic aid, lost work productivity, resource use due to acute exacerbations). IPF-patients were reported by subgroup to make comparisons between groups.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing informed consent until end of study, up to 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients With IPF - Overall Population	31 of 204 (15.2%)	12 of 89 (13.5%)	30 of 204

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mireia Canals, +34607550925 study chair

mireia.canals@boehringer-ingelheim.com

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 31 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Idiopathic Pulmonary Fibrosis (IPF)-Related Costs (time frame: 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03386994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.