Supplementation of curcumin and piperine plus standard therapy to prevent exacerbations in patients with Chronic Obstructive Pulmonary Disease (CUPISCO TRIAL: CUrcumin and PIperine Supplementation for COpd). A study protocol.

Background: Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent condition that leads to a variety of complications that increase social and economic burdens. Although current treatment guidelines target symptomatic relief, including strategies to reduce future exacerbations and improve patients' quality of life, there is still a need for an effective intervention that also reduces the healthcare cost associated with this disease through reducing exacerbation-related hospitalization. Curcumin and piperine are natural and inexpensive components proven to inhibit the main inflammatory cascade responsible for COPD exacerbations. Objective: This trial aims to evaluate the supplementation of curcumin and piperine with COPD standard therapy to reduce the exacerbation rate in COPD patients compared to standard therapy alone.    Methods: This will be a phase II multi-center, randomized, placebo-controlled, triple-blinded, parallel-group trial with COPD patients, classified in GOLD C and D groups, who are currently under standard treatment. Supplementation with 4g of curcumin combined with 20mg of piperine versus placebo will be evaluated during a period of 12 months. One thousand seven hundred and sixteen participants will be enrolled, with 858 participants for the control and intervention groups. The primary outcome will be the mean rate of moderate and severe exacerbations. Secondary outcomes will include time until first moderate or severe COPD exacerbation, St. George's Respiratory Questionnaire response, clinically significant change in post-bronchodilator forced expiratory volume, modification in the GOLD groups, and the presence of adverse events. Discussion: This will be the first randomized clinical trial to test curcumin plus piperine in COPD patients for twelve months. This intervention may improve patients’ quality of life and reduce the economic and social burden of this disease.