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

UMIN ID: UMIN000055508

Registered date:15/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: 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.
• Date of first enrollment: 2024/09/01
• Target sample size: 126
• Countries of recruitment: Asia(except Japan)
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 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 Outcome: - 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)

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Taipei Veterans General Hospital
• Source(s) of Monetary Support: National Science and Technology Council
• Secondary ID(s): 240305