A75-07 Oscillometry Helps Diagnose Pre-COPD and Fluticasone/ Vilanterol Could Help Treat It: Results From Indian Early COPD Network Pilot Study

Background

Currently no objective parameters exist to diagnose Pre-COPD, often leading to misdiagnosis. There is no clear guidance for treatment either. Small airways disease is hallmark of Pre-COPD and Oscillometry measurement is the most sensitive. We hypothesized oscillometry could help diagnose Pre-COPD, especially Ax, which is a measure of lung stiffness and lung recoil. With the negative RETHINC study we explored whether fluticasone/vilanterol (FF/V) extra fine particle formulation could treat Pre-COPD.

Methods

We performed a 12-week, randomized, double-blind, placebo-controlled trial across 10 Indian centres. Adults aged 35-55 years, no previous history of or treatment for Asthma, > 10 pack years of smoking or equivalent biomass fuel exposure, CAT score >10, normal spirometry (FEV1>80% predicted and FEV1/FVC>0.7) with no reversibility, and elevated Ax (>6cmH₂O/L.s using Tremoflo C-100) were enrolled. Participants underwent blood tests, HRCT, and randomized to once-daily FF/V or placebo.CAT score, spirometry, and oscillometry were performed at baseline, 6, and 12 weeks. Primary endpoints were change in CAT score and Oscillometry parameters.

Results

149 individuals screened, 93 eligible participants randomized (FF/V, n = 43; Placebo n = 50). Data for 67 participants (Active 32, Placebo 35) available for analysis. Both groups were well matched with high normal spirometry. Median Ax (cmH₂O/L.s) was 12.4 in FF/V and 13.7 in Placebo.FF/V led to a bigger improvement in CAT score than Placebo (-9.16vs-6.69; p = 0.048): difference of 2.46 was clinically and statistically significant (MCID for CAT is 2). FF/V improved Ax significantly (-3.02 vs -0.13; p < 0.05, but no change in spirometry, R5 or R5-R20 (table 1). There was no correlation between Eosinophil count and any outcome measures. Emphysema was reported in 23% participants, bronchial wall thickening in 16.6% by study radiologist. 25.6% had >5%emphysema as per FDA approved Lung Density Analysis.

Conclusion

Oscillometry helped diagnose pre-COPD and FF/V improved symptoms and Ax.These findings suggest that oscillometry (Ax > 6) may serve as a more sensitive, parameter available in office setting for diagnosing Pre-COPD in at-risk individuals who would be missed by spirometry. Ax > 6 ( but not R5 or R5-20) is a treatable trait that helps identify patients with Pre-COPD that would respond to inhaled therapy.With no past history of asthma, no reversibility, or change in spirometry, no correlation between eosinophil count and outcome measures and presence of emphysema in almost 25% participants, makes Asthma unlikely in this cohort.A larger study is needed to assess whether these findings are reproducible and generalisable.

This abstract is funded by: none