UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034005 |
|---|---|
| Receipt number | R000038557 |
| Scientific Title | Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study |
| Date of disclosure of the study information | 2018/09/03 |
| Last modified on | 2020/03/05 23:38:30 |
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Basic information
Public title
Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study
Acronym
Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study
Scientific Title
Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study
Scientific Title:Acronym
Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will aim to assess the improvement of forced expiratory volume in one second (FEV1) by Inhaled corticosteroid in stable COPD patients with FeNO > 35 ppb.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The primary outcome is change of post-bronchodilator FEV1 by using high-dose ICS.
Key secondary outcomes
The secondary outcomes are improvement of CAT score, %FEV1, %FVC.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After enrollment, they made 2 outpatient visits. At visit 1, patients' baseline characteristics will be recorded and subjects will receive budesonide 200 microgram, 8 puffs daily for 28 days. At visit 2, 28 days after the enrollment, post-bronchodilator pulmonary function test will be investigated.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD patients on treatment with LABA, LAMA, LAMA/LABA or none who were more than 40 years and met all of the following criteria will be recruited; current or ex-smokers of more than 10 pack-years, post-bronchodilator FEV1/forced vital capacity (FVC) ratio < 70%, FeNO > 35ppb.
Key exclusion criteria
We will exclude patients taking oral or inhaled corticosteroids within 1 month of trial entry.
We will also exclud unstable COPD patients who have an exacerbation within 6 weeks of trial entry or have severe intercurrent diseases.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Shiroshita |
Organization
Kameda Medical Center
Division name
pulmonology
Zip code
2960001
Address
Department of Pulmonary Medicine, Kameda Medical Center, 929 Higashi-cho, Kamogawa, Chiba 296-8602
TEL
+81-4-7092-2211
akihirokun8@gmail.com
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Shiroshita |
Organization
Kameda Medical Center
Division name
pulmonology
Zip code
2960001
Address
Department of Pulmonary Medicine, Kameda Medical Center, 929 Higashi-cho, Kamogawa, Chiba 296-8602
TEL
+81-4-7092-2211
Homepage URL
akihirokun8@gmail.com
Sponsor or person
Institute
Department of Pulmonary Medicine, Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Pulmonary Medicine, Kameda Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center
Address
929 Higashi-cho
Tel
+818038074960
akihirokun8@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | 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
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038557
