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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021901
Receipt No. R000025256
Scientific Title Effect of high-flow nasal cannula therapy on exercise tolerance in patients with stable interstitial lung disease
Date of disclosure of the study information 2016/04/13
Last modified on 2017/10/18

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Basic information
Public title Effect of high-flow nasal cannula therapy on exercise tolerance in patients with stable interstitial lung disease
Acronym High-flow nasal cannula therapy for stable interstitial lung disease
Scientific Title Effect of high-flow nasal cannula therapy on exercise tolerance in patients with stable interstitial lung disease
Scientific Title:Acronym High-flow nasal cannula therapy for stable interstitial lung disease
Region
Japan

Condition
Condition Interstitial lung disease
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a prospective, randomized crossover study for evaluation the efficacy and safety of high-flow nasal cannula therapy in patients with interstitial lung disease who have oxygen desaturation during exertion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Endurance exercise time
Key secondary outcomes 1. Dyspnea intensity on exertion
(modified Borg scale)
2. Desaturation during exertion(SpO2)
3. Maximum heart rate during exertion
4. Patient comfort during exertion
(NRS scale)
5. Adverse events

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Arm A
Symptom limited incremental exercise tests were performed on electrically braked cycloergometer with room air or each oxygen flow at rest. On the following day, using a randomized, crossover protocol, two endurance studies were performed. The endurance study work-load was set at 80 % of the maximum work-load achieved during the prior incremental study.
First day: Endurance exercise test with Venturi mask (FiO2 0.5).
Second day: Endurance exercise test with high-flow nasal cannula therapy (50L/min, FiO2 0.5).
Interventions/Control_2 Arm B
Symptom limited incremental exercise tests were performed on electrically braked cycloergometer with room air or each oxygen flow at rest. On the following day, using a randomized, crossover protocol, two endurance studies were performed. The endurance study work-load was set at 80 % of the maximum work-load achieved during the prior incremental study.
First day: Endurance exercise test with high-flow nasal cannula therapy (50L/min, FiO2 0.5).
Second day: Endurance exercise test with Venturi mask (FiO2 0.5).
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with stable interstitial lung disease who have oxygen desaturation (SpO2 lower than 88%) during treadmill exercise tolerance test on room air or each oxygen flow at rest.
2. Patients who agree to participate in the study with the written informed consent.
Key exclusion criteria 1.Patients with obstructive pulmonary disease (FEV1/FVC lower than 0.7)
2.Patients with pneumothorax and/or pneumomediastinum
3.Patients with unstable diseases or the history of acute exacerbation within the last 1 month.
4.Patients with diseases affecting the outcome who regarded as inadequate for the study by the investigators.
5.Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
6.Any other patients who are regarded as inadequate for the study enrollment by the investigators.
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Taniguchi
Organization Tosei General Hospital
Division name Department of Respiratory Medicine and Allergy
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi, 489-8642 Japan
TEL 0561-82-5101
Email taniguchi@tosei.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Atsushi Suzuki
Organization Tosei General Hospital
Division name Department of Respiratory Medicine and Allergy
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi, 489-8642 Japan
TEL 0561-82-5101
Homepage URL
Email atsushi-salyu@hotmail.co.jp

Sponsor
Institute Department of Respiratory Medicine and Allergy, Tosei General Hospital
Institute
Department

Funding Source
Organization Pacific Medico Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 公立陶生病院/Tosei General Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 13 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
2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 14 Day
Last follow-up date
2017 Year 10 Month 31 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 13 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025256

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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