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

NCT07457762 | Recruiting DMC

• 1 other identifier: 7.534.776
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension (PAH)

Keywords

PAH; adherence; iloprost

Outcome Measures

Primary Outcomes (1)

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

  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.

  over 20 weeks of follow-up

Study Arms (2)

Healthcare professional intervention

EXPERIMENTAL

The patients will receive guidance on inhaler use and adherence

Device: The patients will receive guidance on inhaler use and adherence

No healthcare professional intervention

NO INTERVENTION

No intervention

Interventions

The patients will receive guidance on inhaler use and adherence DEVICE

The patients will receive guidance on inhaler use and adherence

Healthcare professional intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• "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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Incor HCFMUSP

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients aged 18 years or older who are treated at the reference center for PH at the Heart Institute of the University of São Paulo School of Medicine will be included in the study. Participants must have an invasive diagnostic confirmation of PAH (MPAP greater than 20 mmHg at rest, presence of PVR equal to or greater than 2 Wood units, and a PCWP equal to or less than 15 mmHg), and be on a stable dose of Iloprost for at least 12 weeks before the study begins. The patients' clinical, laboratory, exercise, hemodynamic, and medication adherence data will be collected at two points: before the start of the study and at the end. Patients who are unable to perform the 6MWT or who have had gastrointestinal bleeding within the last 12 weeks before the start of the study will be excluded. Patients will be monitored for 20 weeks. Patients will be randomized in a 1:1 ratio into an intervention group (pharmaceutical care) and a control group (standard care).

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: March 9, 2026
• Study Start: May 1, 2025
• Primary Completion: April 28, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: March 9, 2026

Record last verified: 2025-12

Locations

BR (1)