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Despite this, approaches to treatment and the efficacy of phosphodiesterase type 5\u00a0inhibition (PDE\u20105i) in COPD\u2010PH are unresolved. We present the clinical rationale and study design to assess the effect of oral tadalafil on exercise capacity, cardiopulmonary hemodynamics, and clinical outcome measures in COPD\u2010PH patients. Male and female patients 40\u201385 years old with GOLD stage 2 COPD or higher and pulmonary hypertension diagnosed on the basis of invasive cardiac hemodynamic assessment (mean pulmonary artery pressure [mPAP] &gt;30\u00a0mmHg, pulmonary vascular resistance [PVR] &gt;2.5 Wood units, and pulmonary capillary wedge pressure \u226418\u00a0mmHg at rest) will be randomized at a 1:1 ratio to receive placebo or oral PDE\u20105i with tadalafil (40\u00a0mg daily for 12\u00a0months). The primary end point is change from baseline in 6\u2010minute walk distance at 12\u00a0months. The secondary end points are change from baseline in PVR and mPAP at 6\u00a0months and change from baseline in peak volume of oxygen consumption (<jats:inline-graphic xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"graphic\/pul2bf00779-math-0001.png\" xlink:title=\"urn:x-wiley:20458940:media:pul2bf00779:pul2bf00779-math-0001\"\/>o<jats:sub>2<\/jats:sub>) during exercise at 12\u00a0months. Changes in systemic blood pressure and\/or oxyhemoglobin saturation (SaO<jats:sub>2<\/jats:sub>) at rest and during exercise will function as safety outcome measures. TADA\u2010PHiLD (TADAlafil for Pulmonary Hypertension assocIated with chronic obstructive Lung Disease) is the first sufficiently powered randomized clinical trial testing the effect of PDE\u20105i on key clinical and drug safety outcome measures in patients with at least moderate PH due to COPD.<\/jats:p>","DOI":"10.1086\/674759","type":"journal-article","created":{"date-parts":[[2014,3,18]],"date-time":"2014-03-18T21:40:53Z","timestamp":1395178853000},"page":"889-897","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":9,"title":["Study Design and Rationale for Investigating Phosphodiesterase type 5 Inhibition for the Treatment of Pulmonary Hypertension Due to Chronic Obstructive Lung Disease: The TADA\u2010PHiLD (TADAlafil for Pulmonary Hypertension Associated with Chronic Obstructive Lung Disease) Trial"],"prefix":"10.1002","volume":"3","author":[{"given":"Bradley 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