EVOLVE, a study by United Therapeutics to evaluate real-world use of next generation pumps for Remodulin was enrolling, August 15, 2023

The aim of the EVOLVE study is to observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with pulmonary arterial hypertension. […]

EVOLVE, a study by United Therapeutics to evaluate real-world use of next generation pumps for Remodulin was enrolling, August 15, 2023 Read Post »

Findings of UK Pulmonary Hypertension Association, PHA UK, survey to investigate how patients and caregivers feel about their clinical data being accessed by researchers are now available

The PHA UK’s survey, launched in June 2023, aimed at understanding patient and caregivers’ thoughts about their clinical data (health records) being accessed as part of a study. A total of 331 persons responded to the survey. The findings have now been published and are available at this link on the PHA UK website.

Findings of UK Pulmonary Hypertension Association, PHA UK, survey to investigate how patients and caregivers feel about their clinical data being accessed by researchers are now available Read Post »

The UK Pulmonary Hypertension Association (PHA UK)’s new trial will test effectiveness of self-help programme for pulmonary hypertension patients with depression

The PHA UK has partnered with psychology researchers from Cardiff University and Nottingham Trent University to conduct a study on a new self-help program for individuals with pulmonary hypertension to manage depression. The study aims to test the effectiveness of a series of self-help booklets and eventually make the program widely available. Learn more at

The UK Pulmonary Hypertension Association (PHA UK)’s new trial will test effectiveness of self-help programme for pulmonary hypertension patients with depression Read Post »

Aerami Therapeutics prepares for initiation of uniPHied, a Phase 2 study trial of AER-901, inhaled imatinib, in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), June 1, 2023

Aerami Therapeutics has announced new additions to its management team as the company prepares for the imminent initiation of the planned “uniPHied” Phase 2 trial of AER-901 (inhaled imatinib), in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). AER-901 is a drug-device combination delivered via a high-performance, handheld nebulizer that

Aerami Therapeutics prepares for initiation of uniPHied, a Phase 2 study trial of AER-901, inhaled imatinib, in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), June 1, 2023 Read Post »

ARTISAN Phase 4 study to assess effect of early and rapid treprostinil therapy in mean pulmonary artery pressure (mPAP) reduction and reverse right ventricle remodeling in pulmonary arterial hypertension patients, June 3, 2023

ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And Function) is a Phase 4, Prospective, Multi-center, Single-Arm Study to assess the effect of early and rapid treprostinil therapy to reduce mean pulmonary artery pressure (mPAP, improve right ventricular (RV) function, and reverse RV remodeling, in patients with pulmonary arterial hypertension (PAH). Estimated enrolment is 50

ARTISAN Phase 4 study to assess effect of early and rapid treprostinil therapy in mean pulmonary artery pressure (mPAP) reduction and reverse right ventricle remodeling in pulmonary arterial hypertension patients, June 3, 2023 Read Post »

Zambon Pharma completes enrolment in Phase 3 clinical trial evaluating new inhaled treatment for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following single or double lung transplant, May 1, 2023

Zambon, a multinational pharmaceutical company, announced today that it has completed enrollment in its two pivotal Phase 3 studies. The trials are designed to evaluate the safety and efficacy of Liposomal Cyclosporine A for Inhalation (L-CsA-i) for the treatment of BOS in adults following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation.  BOS is a

Zambon Pharma completes enrolment in Phase 3 clinical trial evaluating new inhaled treatment for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following single or double lung transplant, May 1, 2023 Read Post »

May 20 is “International Clinical Trials Day”, a day to raise awareness about clinical trials and their contribution to public health

The International Clinical Trials Day is organised yearly on May 20, since 2014, by the Association of Clinical Research Professionals (ACRP), as an opportunity for the clinical research community to to celebrate what has been accomplished in this field and recommit to push even further. Learn more about International Clinical Trials Day at this link

May 20 is “International Clinical Trials Day”, a day to raise awareness about clinical trials and their contribution to public health Read Post »

Findings of a study published in Thorax (BMJ Journals) highlights the importance of integrating pulmonary arterial hypertension patients’ perceptions in the elaboration of clinical trials – May 4, 2023

The aim of this study was to investigate the value given by patients’ and caregivers’ to components of composite outcomes in pulmonary arterial hypertension (PAH) clinical trials. There were 335 participants, of which 257 were patients with pulmonary arterial hypertension. The study findings revealed that most outcomes were considered of major or mild-to-moderate importance to

Findings of a study published in Thorax (BMJ Journals) highlights the importance of integrating pulmonary arterial hypertension patients’ perceptions in the elaboration of clinical trials – May 4, 2023 Read Post »

IMPAHCT, a Phase 2b/3 study investigating a potential new medication, AV-101, developed by aerovate therapeutics, for patients with pulmonary arterial hypertension, April 30, 2023

AV-101 is an investigational, proprietary dry powder inhaled formulation of imatinib which is intended to address the underlying hyperproliferation of cells within the narrowed arteries of the lungs. It is designed to deliver antiproliferative therapy directly to the lungs, allowing more of the drug to access the diseased tissues directly while simultaneously reducing systemic exposure

IMPAHCT, a Phase 2b/3 study investigating a potential new medication, AV-101, developed by aerovate therapeutics, for patients with pulmonary arterial hypertension, April 30, 2023 Read Post »

The Pulmonary Hypertension Association, PHA, is accepting applications for its new grant to support junior pulmonary hypertension researchers. Applications are due March 20, 2023

This research award grants up to $65,000 for one year and supports junior pulmonary hypertension scientists. Proposals must be pulmonary hypertension related research projects that have been favourably reviewed for a National Institutes of Health Early Career Award (K award) but not funded. The award provides bridge funding so the project can generate sufficient preliminary

The Pulmonary Hypertension Association, PHA, is accepting applications for its new grant to support junior pulmonary hypertension researchers. Applications are due March 20, 2023 Read Post »

Supervised pulmonary hypertension exercise rehabilitation (SPHERe) clinical trial recruitment

The aim of the SPHERe study is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with pulmonary hypertension in the community/outpatient setting. The SPHERe study is the first multi-centre clinical randomised controlled trial (RCT) to assess the clinical and cost

Supervised pulmonary hypertension exercise rehabilitation (SPHERe) clinical trial recruitment Read Post »

Effects of an inhaled soluble guanylate cyclase (sGC) stimulator MK-5475 in pulmonary arterial hypertension (PAH), in Respiratory Medicine, January 2023

This Phase 1 study evaluated efficacy/safety of inhaled single-dose MK-5475, an investigational, small-molecule stimulator of soluble guanylate cyclase designed for inhaled delivery via a dry-powder inhaler device, in participants with pulmonary arterial hypertension. The findings reveal that treatment with inhaled single-dose MK-5475 reduced pulmonary vascular resistance and increased pulmonary blood volume. Compared to the placebo, MK-5475 was

Effects of an inhaled soluble guanylate cyclase (sGC) stimulator MK-5475 in pulmonary arterial hypertension (PAH), in Respiratory Medicine, January 2023 Read Post »

“Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study”, The Lancet, October 2022

RACE is a (completed) phase 3, multicentre, open-label, parallel-group, randomised controlled trial done in 23 French centres of expertise for pulmonary hypertension enrolling treatment-naive patients aged 18–80 years with newly diagnosed, inoperable chronic thromboembolic pulmonary hypertension and pulmonary vascular resistance of more than 320 dyn·s/cm5. A summary of the article is available on The Lancet

“Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study”, The Lancet, October 2022 Read Post »

How do clinical trials work? Here is a video by top pulmonary hypertension medical expert Vallerie McLaughlin that explains it all! A phaware global initiative

Vallerie McLaughlin, MD from Michigan Medicine’s Cardiovascular Center, discusses the basics of clinical trials in this very informative video care of phaware. Check out the video on the phaware YouTube channel at this link Learn more about phaware at this link

How do clinical trials work? Here is a video by top pulmonary hypertension medical expert Vallerie McLaughlin that explains it all! A phaware global initiative Read Post »

European Patients’ Academy on Therapeutic Innovation (EUPATI), a patient-led initiative to enhance knowledge of medicine R & D processes

The European Patients’ Academy on Therapeutic Innovation (EUPATI) is a patient-led partnership working across stakeholders to enhance patient engagement, registered as an independent non-profit Foundation in the Netherlands. It announced today an important milestone for their “Toolbox”: 5 million unique users since its launch in 2016. Explore the EUPATI Toolbox to learn more about medicine

European Patients’ Academy on Therapeutic Innovation (EUPATI), a patient-led initiative to enhance knowledge of medicine R & D processes Read Post »

The EU Clinical Trials Regulation came into force 31st of January 2022

The European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation comes into force today, the 31st of January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. Prior to

The EU Clinical Trials Regulation came into force 31st of January 2022 Read Post »

“Accelerating Clinical Trials in the EU for better clinical trials that address patients’ needs”, a joint initiative of the EU Commission, the European Medicines Agency Heads of Medicines Agencies (HMA)

On January 2022 a new initiative launched by the European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) aims to transform how clinical trials are initiated, designed, and run. This initiative, called “Accelerating Clinical Trials in the EU for better clinical trials that address patients’ needs“, aims to further develop

“Accelerating Clinical Trials in the EU for better clinical trials that address patients’ needs”, a joint initiative of the EU Commission, the European Medicines Agency Heads of Medicines Agencies (HMA) Read Post »

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