Pulmonary Arterial Hypertension (PAH)AIRDROPNCT07457762
AIRDROP: Can we Improve Adherence to Inhaled Treatment for Pulmonary Arterial Hypertension?
A study testing The patients will receive guidance on inhaler use and adherence in people with Pulmonary Arterial Hypertension (PAH), run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- The patients will receive guidance on inhaler use and adherence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2025to 28 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- "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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Incor HCFMUSP
São Paulo, São Paulo, 01246-000
Caio JC Santos Fernandes, PhD, 55 11 992149574, cjcfernandes@yahoo.com.br
Carla Rios Cruz, PhD student, 55 11 986068469, carla_rcruz@hotmail.com
About this study
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)
- Being tested
- The patients will receive guidance on inhaler use and adherence
- Keywords
- PAH, adherence, iloprost
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patients will receive guidance on inhaler use and adherenceDevice
The patients will receive guidance on inhaler use and adherence
| Study group | Role | What they receive |
|---|---|---|
| Healthcare professional intervention | Experimental | The patients will receive guidance on inhaler use and adherence Receives: Device: The patients will receive guidance on inhaler use and adherence |
| No healthcare professional intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 20 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 May 2025
- Primary completion28 Apr 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caio Júlio César dos Santos Fernandes, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457762
- Sponsor's protocol ID
- 7.534.776
- Other IDs
- 7.534.776
- Acronym
- AIRDROP
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIRDROP: Can we Improve Adherence to Inhaled Treatment for Pulmonary Arterial Hypertension?
- ClinicalTrials.gov ID
- NCT07457762
- Acronym / sponsor ID
- AIRDROP / 7.534.776
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- PAH, adherence, iloprost
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 28 Apr 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Healthcare professional intervention | Experimental | Device: The patients will receive guidance on inhaler use and adherenceThe patients will receive guidance on inhaler use and adherence |
| No healthcare professional intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- "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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The patients will receive guidance on inhaler use and adherenceThe patients will receive guidance on inhaler use and adherence | Device | Healthcare professional intervention |
Primary outcome
Medication Adherence Measured by the Martín-Bayarre-Grau (MBG) Questionnaire.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The patients will receive guidance on inhaler use and adherence in people with Pulmonary Arterial Hypertension (PAH), run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Measured by the Martín-Bayarre-Grau (MBG) Questionnaire. (time frame: over 20 weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.