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NCT Number: NCT07356375

Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a rare and serious condition that affects the blood vessels of the lungs and can significantly limit daily activities and quality of life. Some patients with PAH use inhaled iloprost, a medication that requires several inhalations per day, which can be difficult to maintain over time. Oral selexipag is an alternative treatment that may reduce treatment burden and improve adherence.

The PROMISE study aims to evaluate how switching from inhaled iloprost to oral selexipag affects patients' quality of life, satisfaction with treatment, and adherence in real-world clinical practice. Patient-reported outcome questionnaires will be used to understand patients' perceptions of symptoms, daily functioning, and overall improvement after the transition.

Adult patients with PAH who are receiving inhaled iloprost and whose physicians decide to switch treatment to oral selexipag will be followed over time. A comparison group of patients who continue using inhaled iloprost will also be observed. The study does not involve any experimental treatment or changes to routine clinical care. All medications are prescribed as part of standard medical practice.

The results of this study may help improve understanding of the patient experience during treatment transitions in PAH and support more patient-centered treatment decisions.

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Key information

Conditions

Pulmonary Arterial Hypertension (PAH) Behavior Health Behavior Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Pulmonary arterial hypertension (PAH) is a progressive and life-threatening disease that requires long-term treatment with targeted therapies. Medications acting on the prostacyclin pathway are an important component of PAH management. Inhaled iloprost has demonstrated clinical and hemodynamic benefits but requires multiple daily inhalations, which may increase treatment burden and negatively affect adherence and daily functioning. Oral selexipag, a selective IP receptor agonist administered twice daily, offers a less complex dosing regimen and may improve treatment persistence and patient experience.

In Brazil, the incorporation of oral selexipag into national treatment guidelines has led to an increasing number of patients transitioning from inhaled iloprost to oral therapy as part of routine clinical care. However, data on patient-reported outcomes, satisfaction, and real-world adherence following this transition are limited, particularly in Latin American populations.

The PROMISE study is a prospective, observational, single-center study designed to assess the patient experience associated with the transition from inhaled iloprost to oral selexipag in adults with PAH. The study focuses on changes in health-related quality of life, treatment satisfaction, global perception of improvement, and objective and self-reported measures of adherence over time. A comparison group of patients who continue treatment with inhaled iloprost will be followed in parallel to provide contextual interpretation of observed changes.

All treatment decisions, including initiation, continuation, titration, or discontinuation of medications, are made exclusively by the treating physician according to standard clinical practice. Participation in the study does not influence therapeutic choices, and no additional interventions beyond routine care are performed. Data collection consists of validated patient-reported outcome measures, structured questionnaires, and review of clinical information obtained during usual follow-up visits.

By capturing patient-centered outcomes in a real-world setting, the PROMISE study aims to improve understanding of the impact of treatment transitions on daily life and adherence in PAH, supporting more informed, patient-focused management strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older.
  • Confirmed diagnosis of pulmonary arterial hypertension (PAH, Group 1) by right heart catheterization.
  • Current treatment with inhaled iloprost as part of routine clinical care.
  • Clinical decision by the treating physician to transition from inhaled iloprost to oral selexipag.
  • Ability to understand and complete patient-reported outcome questionnaires.
  • Provision of written informed consent.

Exclusion criteria

  • Significant cognitive impairment or sensory deficits that prevent completion of study questionnaires.
  • Unstable or decompensated comorbid conditions that may interfere with treatment adherence or study participation.
  • Refusal or inability to provide informed consent.

Treatment and study plan

Selexipag

Drug

Exposure to oral selexipag following transition from inhaled iloprost as part of routine clinical care in adults with pulmonary arterial hypertension. The decision to initiate, titrate, or discontinue selexipag is made exclusively by the treating physician, independent of study participation. No study-mandated intervention or treatment assignment is performed. The study observes patient-reported outcomes, treatment satisfaction, and adherence associated with this treatment transition.

Other names: Oral selexipag, IP receptor agonist

Primary outcomes

  1. Change in Health-Related Quality of Life (EMPHASIS-10)

    Time frame: From baseline (prior to transition) to 16-24 weeks of follow-up

    Change in health-related quality of life assessed by the emPHasis-10 questionnaire (Pulmonary Hypertension-Specific Quality of Life Instrument), measured as the difference in total score between baseline (prior to transition from inhaled iloprost to oral selexipag) and follow-up.

    The emPHasis-10 is a patient-reported outcome measure ranging from 0 to 50, with lower scores indicating better health-related quality of life. The outcome evaluates within-patient change following treatment transition in routine clinical practice.

Secondary outcomes

  1. Change in Treatment Satisfaction (TSQM-9)

    Time frame: From baseline (prior to transition) to 3-4 weeks and 16-24 weeks after transition

    Change in treatment satisfaction assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM-9), measured before the transition from inhaled iloprost and after transition to oral selexipag.

    The TSQM-9 is a patient-reported outcome measure evaluating treatment effectiveness, convenience, and global satisfaction domains. Domain scores range from 0 to 100, with higher scores indicating greater treatment satisfaction. The outcome allows within-patient comparison of treatment satisfaction before and after the treatment switch in routine clinical practice.

  2. Patient Global Impression of Change (PGIC)

    Time frame: 3-4 weeks and 16-24 weeks after transition

    Patient-reported global impression of change assessed using the Patient Global Impression of Change (PGIC) scale, reflecting the patient's overall perception of improvement or worsening following the transition from inhaled iloprost to oral selexipag.

    The PGIC is a patient-reported outcome measure consisting of a 7-point Likert scale ranging from "very much worse" to "very much improved," with higher scores indicating greater perceived improvement. This outcome also explores the correlation between PGIC ratings and changes in other patient-reported outcomes.

  3. Objective Adherence to Selexipag

    Time frame: From transition to 16-24 weeks of follow-up

    Objective treatment adherence assessed by the percentage of days with twice-daily selexipag use, treatment interruptions, and the highest titrated dose achieved during follow-up, as documented in routine clinical practice.

  4. Perceived Treatment Burden

    Time frame: From baseline (prior to transition) to 16-24 weeks after transition

    Perceived treatment burden evaluated before the transition, based on the number of daily inhalations with iloprost, and after the transition, based on patient-reported convenience of the oral selexipag regimen.

  5. Adverse Events and Health Care Utilization

    Time frame: From transition to 16-24 weeks of follow-up

    Occurrence of adverse events and health care utilization, including hospitalizations and unplanned outpatient visits, recorded during routine clinical follow-up after transition to oral selexipag.

  6. Responder Status Based on EMPHASIS-10

    Time frame: From baseline to 16-24 weeks of follow-up

    Proportion of patients achieving a clinically meaningful improvement in health-related quality of life, defined as a decrease of at least 6 points (minimal clinically important difference) in the EMPHASIS-10 score between baseline and follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Caio Fernandes Principal Investigator, MD

CONTACT

[email protected]

+551126615034

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

PROMISE: Evaluation of Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension

Acronym: PROMISE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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