Anti-reflux treatment on Gastroesophageal reflux-related airway inflammation during exacerbating COPD patients

Gastroesophageal reflux related-acute exacerbation of COPD- the impact of refluxate on airway inflammation before and after anti-reflux treatment - GER-related AECOPD- effect of anti-reflux treatment

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055508

Enrollment

126

Registered

2024-09-15

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 inhibi

Interventions

PPI only (GERD group) PPI plus prokinetic agent (GERD-P group)

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Countries

Asia(except Japan)

Contacts

Public ContactKang-Cheng Su

Taipei Veterans General Hospital Department of Chest Medicine

kcsu@vghtpe.gov.tw+886-2-28712121-3152

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026