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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026376
Receipt No. R000030312
Scientific Title Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis
Date of disclosure of the study information 2017/03/03
Last modified on 2017/09/04

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Basic information
Public title Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis
Acronym Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in IPF
Scientific Title Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis
Scientific Title:Acronym Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in IPF
Region
Japan

Condition
Condition Idiopathic pulmonary fibrosis(IPF)
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of long-term pulmonary rehabilitation (PR) in patients with IPF under nintedanib therapy. For long-term PR, sustainable long-term maintenance rehabilitation is followed to a short-term induction pulmonary rehabilitation program.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change from baseline in 6 minute walk distance (6MWD) (m) after 12 months of treatment
Key secondary outcomes Main secondary endpoints:
Change from baseline in endurance time in cycle ergometer after 12 months of treatment
Other secondary endpoints:
Following endpoints will be assessed after 12 months.
1)Change from baseline in SGRQ total score
2)Relative change from baseline (%) in 6MWD
3)Physical activity (triaxial accelerometer), health status (SGRQ domain scores and CAT score), dyspnoea (TDI, dyspnoea-12), HADS
4)FVC, DLCO, PaO2, SpO2 (at rest and after 6MWD test)
5)Rate of mortality and rate of unscheduled hospitalization
6)In addition to the assessment of 12 months, change from baseline in 6 minute walk distance (m) and all secondary endpoints will be assessed after 6 months of treatment.
7)Compliance to planed long term rehabilitation (ratio: actual/plan) in nintedanib + rehabilitation group
8)Percentage of patients whose compliance are >= 70% (good compliant patients) in the nintedanib + rehabilitation group
9)Change from baseline (m) in 6 minute walk distance in good compliant patients

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Medicine Device,equipment Other
Interventions/Control_1 Short-term induction pulmonary rehabilitation (2/1w for the first 12w) + Maintenance pulmonary rehabilitation and outpatient visit (1/4w) Total 52w. / No intervention
Interventions/Control_2 Nintedanib / both group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients aged 40 =< and < 80 years at informed consent
2)Patient with IPF diagnosed according to the diagnosis criteria of INPULSIS trial and 2011 IPF guideline
3)200m=<6MWD of the past=<600m
4)Patient with dyspnoea on exercise (1=<mMRC=<3)
5)Stable patients without any infection nor acute exacerbation within 3 months
6)Patients who are already receiving Nintedanib at least 4 weeks prior to participating the study and expected to be able to take nintedanib for more than 12 months in this study
7)Patients who can visit hospital for the first twice a week, and every 2-4 weeks for follow 40 weeks to take outpatient rehabilitation program.
8)Patients who can comply with the instructed exercise and record it in diary.
9)Patients who can adequately answer to the PRO(QOL) questionnaire
10)%FVC>=50%, 79%>=%DLco>=30%
11)Written informed consent is obtained
Key exclusion criteria 1)Patients with connective tissue disease, known neuromuscular disease or other orthopedic problem which may affect to exercise assessment, other disease requires exercise limitation
2)Patients who received pulmonary rehabilitation within 12 months
3)Patients with oral corticosteroids >15mg/day (prednisolone equivalent) or immunosuppressive agents within 3 months
4)Patients with pirfenidone within 3 months
5)Patients with unstable angina, a history of myocardial infarction or received percutaneous transluminal coronary angioplasty or coronary-artery bypass surgery within 1 month or a history of a cerebrovascular disease within 6 months.
6)Patients who requires antiarrhythmic therapy
7)Patients with serious pulmonary hypertension
8)ALT or AST > 2x upper limit of normal
9)Total bilirubin > 2x upper limit of normal
10)Creatinine clearance < 30mL/min
11)Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin) or high dose antiplatelet therapy.
12)Pregnant women and women of possibly pregnant.
13)Patients who cannot be evaluated by 6 minute walk test for any reason.
14)Other patients who are judged by the investigator as not adequate to participate in the study.
15)History of malignant disease within 3 years.
Target sample size 84

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Kozu
Organization Nagasaki University
Division name Institute of Biomedical Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL +95-819-7963
Email ryokozu@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Kataoka
Organization Tosei General Hospital
Division name Respiratory Medicine and Allergy
Zip code
Address 160 Nishi-oiwake-cho, Seto city, Aichi, Japan
TEL +561-82-5101
Homepage URL
Email kataoka@tosei.or.jp

Sponsor
Institute Central Japan Lung Study Grou
Institute
Department

Funding Source
Organization Nipponn Boehringer Ingelheim CO ., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 No.605
Org. issuing International ID_1 Tosei General Hospital IRB
Study ID_2 17082106
Org. issuing International ID_2 Nagasaki University Hospital
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 03 Day
Last modified on
2017 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030312

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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