UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026376 |
|---|---|
| Receipt number | 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 | 2021/07/30 19:43:03 |
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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 | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
8528523
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
+95-819-7963
ryokozu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Kataoka |
Organization
Tosei General Hospital
Division name
Respiratory Medicine and Allergy
Zip code
489-8642
Address
160 Nishi-oiwake-cho, Seto city, Aichi, Japan
TEL
+561-82-5101
Homepage URL
kataoka@tosei.or.jp
Sponsor or person
Institute
Central Japan Lung Study Grou
Institute
Department
Personal name
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
Tosei General Hospital IRB
Address
160 Nishi-oiwake-cho, Seto city, Aichi, Japan
Tel
+561-82-5101
ychikenn@tosei.or.jp
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 03 | Day |
Last modified on
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030312
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