Phase 2 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are seen as outpatients and have been diagnosed with COPD, shown by breathing test results or evidence of emphysema on a chest scan confirmed by a study doctor.
• People who have evidence of raised pressure in the arteries of the lungs, shown by at least one of the following: specific measurements on a chest CT scan done within the past 12 months, a heart ultrasound done within the past 6 months showing elevated pressure readings, or a right heart catheter procedure done within the past 6 months when the person was medically stable.
• People who experience significant shortness of breath, scoring at least 20 on a specific breathlessness questionnaire completed at the first study visit.
• People who have been taking at least one long-acting inhaler (bronchodilator) for at least 4 weeks before the first study visit.
• People aged between 35 and 89 years.
• Women who could potentially become pregnant and who have been using an approved method of contraception (such as an IUD, implant, oral contraceptives, barrier methods, or abstinence) for the past three months, or whose male partner has had a vasectomy, or who have had a tubal ligation, a medical condition preventing pregnancy, are in a same-sex relationship, or have a male partner unable to father children — and who also have a negative pregnancy test on the day of the study visit.
• Women who cannot become pregnant because they have had a surgical procedure such as removal of the ovaries, fallopian tubes, or uterus, or who have gone through menopause (no menstrual period for more than 6 months).

Who may not be able to join:

• People whose raised lung artery pressure has been classified under specific medical categories unrelated to COPD, including certain inherited or drug-caused forms, forms linked to heart problems, forms caused by blood clots, or other forms not related to primary lung disease.
• People who have consistently low blood pressure in an outpatient setting, recorded by a healthcare provider at least three times over one week.
• People with moderate or severe liver disease.
• People with severely reduced kidney function.
• People whose heart ultrasound (done within 6 months) showed significant heart valve problems, stiffening of the heart muscle, a reduced pumping function, or who have had a heart valve replacement.
• People who have any ongoing condition (other than breathlessness) that would prevent them from taking part in the study as required.
• People who have had unstable chest pain, a heart attack, or a stroke within the past 6 months.
• People who currently need to take nitrate medications for any reason.
• People who currently have an active prescription for a PDE-5 inhibitor (a type of medication) or another medication used to widen the blood vessels in the lungs (other than oxygen).
• People who have a history of certain eye conditions, including retinitis pigmentosa, a specific type of optic nerve damage, or a crowded optic disc noted in their medical records.
• People who have an allergy to PDE-5 inhibitor medications, certain physical conditions, sickle cell anaemia, multiple myeloma, leukaemia, bleeding disorders, an active stomach ulcer, or the eye conditions listed above.
• People currently taking any of the following medications: rifampin, systemic antifungal azole drugs, protease inhibitors, phenobarbital, or dilantin (phenytoin).
• People who are pregnant, possibly pregnant, or breastfeeding.
• People who have been diagnosed with a specific rare lung blood vessel condition called pulmonary veno-occlusive disease.
• People whose blood oxygen levels remain consistently low (below 90%) even while using supplemental oxygen at rest, as recorded by a healthcare provider over one week.
• People who have been diagnosed with obstructive sleep apnoea but do not have a prescribed treatment for it.
• People who have been newly prescribed (less than 4 weeks) an inhaler, a fluid-reducing medication, or who have recently started a pulmonary rehabilitation programme at the time of the first study visit.
• Students, employees of the VA health system, people with impaired decision-making ability, people who are not literate or do not speak English, and people who are terminally ill.
• People who have had a COPD flare-up or a heart failure flare-up within the past 4 weeks.
• People who are currently taking or are about to be prescribed the medication doxazosin.

Important: Always verify eligibility with the trial site directly before applying.