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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034005 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | COPD | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 23 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Pulmonary Medicine, Kameda Medical Center |
Institute | |
Department |
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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038557 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |