An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a serious condition where the blood vessels in the lungs become thick and narrow. This makes it harder for the heart to pump blood, causing tiredness and breathlessness. This clinical study is testing an inhaled medicine called GB002. It is an 'open-label extension' study, which means everyone who takes part will receive the active study drug—no one receives a dummy drug (placebo). Researchers want to find out how safe the medicine is over a longer period. They also want to see if it helps improve day-to-day fitness by measuring how far participants can walk in six minutes. The study is for adults aged 18 and over who have this specific type of lung condition. Taking part helps doctors learn if GB002 could become an effective long-term treatment option in the future.
At a glance
What is this study about?
Pulmonary arterial hypertension (PAH) happens when high blood pressure develops in the arteries connecting your heart and lungs. Over time, these blood vessels become stiff and narrow. Your heart has to work much harder to push blood through them, which often leaves you feeling very tired, dizzy, or breathless during everyday activities.
Researchers are developing an inhaled medicine named GB002 to help treat PAH. Because it is breathed directly into the lungs through the mouth, the medicine can get straight to the blood vessels where it is needed most. This study aims to understand how well the medicine works and whether it causes any unwanted side effects over a longer period of time.
This trial is called an 'extension study'. That means it is designed for people who have already finished an earlier trial of GB002. It is also 'open-label', meaning both you and your study doctors will know you are receiving the real treatment. The main goals are to track any side effects and see if the treatment helps you walk further during a standard six-minute walking test.
Finding new, effective treatments for PAH is vital. If GB002 proves safe and helpful over time, it could offer a new way to manage symptoms and improve the quality of daily life for people living with this condition.
Key takeaways
- Tests an inhaled medicine called GB002 for adults with pulmonary arterial hypertension (PAH).
- This is an open-label study, so all participants receive the real treatment.
- Mainly checks long-term safety and whether walking distance improves.
- Open to adults aged 18 and older, usually those who completed a previous GB002 trial.
- Participation is entirely voluntary and you can stop at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with WHO Group 1 Pulmonary Arterial Hypertension. Men and women can both take part.
Because this is an extension study, participants are usually people who have already taken part in an earlier study testing GB002. You must be able to use an inhaler to breathe the medicine into your lungs.
Your study doctor will carefully review your medical history and current health. If you have other serious medical conditions that might make taking part unsafe, or if you cannot attend regular clinic appointments, this study may not be suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged 18 or older?
- Have you been diagnosed with WHO Group 1 Pulmonary Arterial Hypertension (PAH)?
- Have you taken part in an earlier trial of the medicine GB002?
- Are you able and willing to use an inhaler as instructed?
- Can you attend regular hospital appointments for check-ups and walk tests?
What does participation involve?
Taking part involves visiting a hospital clinic regularly for health checks. You will be asked to inhale the study medicine by mouth each day using a special device. At your visits, the medical team will check your blood pressure, listen to your heart and lungs, and take blood samples to monitor your overall safety. You will also do a six-minute walk test to see how far you can comfortably walk on a flat surface. Your doctor will discuss the exact duration of the study with you, as extension studies often follow patients over several months or years.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedCzechia
Common questions
What does 'open-label' mean?
It means there is no dummy drug (placebo). Both you and your doctor will know that you are receiving the active study medicine.
How is the medicine given?
GB002 is taken by mouth using an inhaler, allowing the medicine to reach your lungs directly.
What is the six-minute walk test?
It is a simple, safe test that measures the distance you can walk at your own pace along a flat corridor in six minutes.
Will taking part cost me anything?
No, the study medicine and all study-related tests are provided free of charge. Most studies also help cover reasonable travel expenses.
Can I leave the study if I change my mind?
Yes, you can choose to withdraw at any time and for any reason, and your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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