UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055508 |
|---|---|
| Receipt number | R000063430 |
| Scientific Title | Gastroesophageal reflux related-acute exacerbation of COPD- the impact of refluxate on airway inflammation before and after anti-reflux treatment |
| Date of disclosure of the study information | 2024/09/15 |
| Last modified on | 2024/09/15 23:37:37 |
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Basic information
Public title
Anti-reflux treatment on Gastroesophageal reflux-related airway inflammation during exacerbating COPD patients
Acronym
Anti-reflux effect on GER-reflux-related airway inflammation during AECOPD
Scientific Title
Gastroesophageal reflux related-acute exacerbation of COPD- the impact of refluxate on airway inflammation before and after anti-reflux treatment
Scientific Title:Acronym
GER-related AECOPD- effect of anti-reflux treatment
Region
| Asia(except Japan) |
Condition
Condition
Patients with COPD coexisting GERD is associated with an increasing acute exacerbation (AECOPD) rate. Still, a causal relationship between refluxate and airway inflammation derived from airway specimens has not been reported yet. The anti-gastric acid intervention resulted in conflicting results in reducing the AECOPD rate. Non-acid refluxate might be the key, but it has not been proven yet, particularly in AECOPD patients. Prokinetic agents are an effective add-on therapy for proton pump inhibitor (PPI) poor-responding GERD. Theoretically, prokinetic agents act as a possible solution to reduce non-acid refluxate. Therefore, we hypothesize that AECOPD patients with coexisting GERD might have elevated levels of non-acid refluxate (bile acids [BAs] and pepsin) and airway inflammation profile (vs. those not coexisting GERD), and these elevated markers might have differential reduction in responding to PPI treatment with or without combined prokinetic agent.
Classification by specialty
| Gastroenterology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether in AECOPD patients, those with coexisting GERD might have elevated levels of the non-acid refluxate (BAs and pepsin) and airway inflammation profile compared with those without coexisting GERD
Basic objectives2
Others
Basic objectives -Others
To investigate in AECOPD patients with coexisting GERD, whether their sputum non-acid markers (BAs and pepsin) and inflammatory markers (interleukin-8 [IL-8], matrix metalloproteinase-9 [MMP-9]) and fractional exhaled nitric oxide (FeNO) might have a differential reduction in responding to proton pump inhibitor (PPI) treatment with or without a combined prokinetic agent
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare treatment changes of sputum levels of non-acid refluxate (BAs and pepsin) and inflammation profiles (IL-8, MMP-9, FeNo) between AECOPD patients coexisting GERD treated with PPI (lansoprazole) in the absence or presence of combined prokinetic agent (mosapride) for 1 and 4 weeks (GERD vs. GERD-P group)
Key secondary outcomes
- The prevalence of GERD at the timing of AECOPD
- Difference of CAT score, FeNO, blood test (CBC/DC, CRP) and sputum levels of non-acid refluxate, airway inflammation profiles between those with or without GERD at the timing of AE (non-GERD group vs. GERD group)
- Treatment changes of CAT score, blood test (CBC/DC, CRP) and sputum levels of non-acid refluxate, airway inflammation profiles in each group (before and after comparisons in each group, respectively)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PPI only (GERD group)
Interventions/Control_2
PPI plus prokinetic agent (GERD-P 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male or female outpatients aged from 40 to 90 years.
2. Spirometry confirmed COPD patients (post-bronchodilation FEV1/FVC < 0.7)
3. Meet the criteria of moderate to severe AECOPD
4. Agree to attend study and sign informed consent.
Key exclusion criteria
1. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
2. A chest X-ray indicating significantly newly developed pneumonia patch
3. Respiratory failure requiring intubation and mechanical ventilation
4. Coexisting life-threatening complications with life expectancy less than 4 weeks
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | Kang-Cheng |
| Middle name | |
| Last name | Su |
Organization
Taipei Veterans General Hospital
Division name
Department of Chest Medicine
Zip code
11217
Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
TEL
+886-2-28712121-3152
kcsu@vghtpe.gov.tw
Public contact
Name of contact person
| 1st name | Kang-Cheng |
| Middle name | |
| Last name | Su |
Organization
Taipei Veterans General Hospital
Division name
Department of Chest Medicine
Zip code
11217
Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
TEL
+886-2-28712121-3152
Homepage URL
kcsu@vghtpe.gov.tw
Sponsor or person
Institute
Taipei Veterans General Hospital
Institute
Department
Personal name
Funding Source
Organization
National Science and Technology Council
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Taiwan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Taipei Veterans General Hospital
Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
Tel
+886-2-28757384
irbopinion@vghtpe.gov.tw
Secondary IDs
Secondary IDs
YES
Study ID_1
240305
Org. issuing International ID_1
2024-05-004A
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 15 | 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
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063430
