AIRDROP: Can we Improve Adherence to Inhaled Treatment for Pulmonary Arterial Hypertension?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The patients will receive guidance on inhaler use and adherence.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension (PAH). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device The patients will receive guidance on inhaler use and adherence
The patients will receive guidance on inhaler use and adherence
Primary outcome measures
- Medication Adherence Measured by the Martín-Bayarre-Grau (MBG) Questionnaire. [Time frame: over 20 weeks of follow-up]
Eligibility criteria
Inclusion criteria
- "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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Brazil · 1 center
- Incor HCFMUSP — São Paulo
Identifiers
NCT: NCT07457762 · 7.534.776 · 7.534.776