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临床试验/NCT07457762
NCT07457762招募中不适用

AIRDROP: Can we Improve Adherence to Inhaled Treatment for Pulmonary Arterial Hypertension?

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
1
主要终点
Medication Adherence Measured by the Martín-Bayarre-Grau (MBG) Questionnaire.

研究概览

简要总结

Pulmonary Arterial Hypertension is a rare and progressive condition that compromises pulmonary circulation and can lead to right ventricular failure. Despite recent advances in diagnosis and treatment, the median survival of patients is only 2.8 years. The treatment for this disease is based on drugs that act on three main pathways: prostacyclin, endothelin, and nitric oxide. Iloprost, a prostacyclin analogue available in an inhaled form, is an important and well-established treatment. However, its mandatory frequent administration, the need for a specific inhalation technique, and its adverse event profile make its use complex. Although pharmacotherapeutic and inhalation technique follow-up by a qualified professional is widely studied in diseases like asthma and COPD, its application in Pulmonary Arterial Hypertension still lacks evidence. Thus, this study aims to evaluate how a pharmacist's intervention can improve treatment adherence, mitigate side effects and difficulties associated with inhalation, in addition to optimizing clinical and hemodynamic outcomes in patients with Pulmonary Arterial Hypertension using iloprost.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • "Adult patients aged ≥ 18 years, treated at the referral center for PH management at the Heart Institute of the University of São Paulo Medical School, with an invasive confirmed diagnosis of PAH (mean pulmonary arterial pressure [mPAP] greater than 20 mmHg at rest, pulmonary vascular resistance [PVR] equal to or greater than 2 Wood units, and pulmonary capillary wedge pressure [PCWP] equal to or less than 15 mmHg), and who have been using Iloprost.

排除标准

  • Patients who are unable to perform the 6-minute walk test (6MWT) or who have experienced gastrointestinal bleeding within the 12 weeks prior to the start of the study will be excluded.

研究组 & 干预措施

No healthcare professional intervention

No Intervention

No intervention

Healthcare professional intervention

Experimental

The patients will receive guidance on inhaler use and adherence

干预措施: The patients will receive guidance on inhaler use and adherence (Device)

结局指标

主要结局

Medication Adherence Measured by the Martín-Bayarre-Grau (MBG) Questionnaire.

时间窗: over 20 weeks of follow-up

The impact of the pharmaceutical intervention on medication adherence will be measured by the Martín-Bayarre-Grau (MBG) Questionnaire, comparing scores before and after the study period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caio Júlio César dos Santos Fernandes

Principal Investigator

University of Sao Paulo General Hospital

研究点 (1)

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