Abstract
Background: Pulmonary hypertension (PH) is a common complication of COPD. Although it is likely that cardiovascular factors limit exercise capacity in patients with disproportional PH, most systemic pulmonary vasodilators failed to show any benefit in COPD. The objective of this trial was to investigate whether inhaled iloprost improves exercise capacity in COPD patients with disproportional PH.
Methods: We performed a randomized, controlled, double-blind, cross-over trial including 19 COPD patients with disproportional PH. Each patient was randomly allocated to nebulized placebo, iloprost 10ug and iloprost 20ug (Multisonic® Infracontrol) before performing a 6MWT at three different time-points. The primary endpoint was the change in walking distance, secondary end-points included exercise test variables. Data were analyzed using mixed-effect models.
Results: Patients had a mean age of 73.2 years±6.7 and FEV1% pred of 51.6%±30.0. The mPAP was 49.2 mmHg±9.3 during exercise. Three patients had severe side-effects, precluding study continuation. The walking distance was not significantly affected by treatment (mean Δ [95% CI] -12.4m [-32.7 to -7.9],p=0.22). Neither the lowest SaO2 (-0.94% [-2.69 to - 0.82], p=0.28) nor the perceived exertion on BORG scale (0.12 [-0.58 to 0.82], p=0.73) differed among the groups. However, VO2 max (-76.9 mL/min [-122,1 to -31.6], p=0.002) and the maximal minute ventilation (-2.99 L/min [-4.5 to -1.5], p<0.001) were significantly lower in patients receiving iloprost as compared to placebo.
Conclusions: Iloprost inhalation does not improve exercise capacity in patients with COPD and disproportional pulmonary hypertension.
- © 2011 ERS