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Study of Sublingual Glyceryl Trinitrate Spray to Reduce Angina in Adults with Symptomatic Coronary Artery Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Adults with symptomatic coronary artery disease, a condition in which the heart’s blood vessels are narrowed and cause chest discomfort called angina, are invited to take part in the trial. The investigational product is a sublingual spray identified as PB056 that contains the active ingredient nitroglycerin, a medication that relaxes blood vessels to help prevent angina attacks. A matching placebo spray that looks the same but does not contain the active drug is also used for comparison.

The purpose of the study is to determine whether regular use of the nitroglycerin spray reduces the overall burden of angina compared with placebo. Participants will be assigned by chance to receive either the active spray or the placebo spray and will use the spray under the tongue each day for eight weeks. During the study they will attend a small number of clinic visits where they will complete simple questionnaires about their chest pain and have basic health checks such as blood pressure measurements.

Sublingual administration means the spray is placed under the tongue, where it is quickly absorbed into the bloodstream. A known possible effect of nitroglycerin is a temporary lowering of blood pressure, which can cause light‑headedness; regular blood pressure checks are performed to monitor this. Participants will also be asked to note any episodes of chest pain that require additional medication, allowing the study to evaluate how well the spray works in everyday life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit and Randomization

    You attend the first clinic visit after joining the study. The study staff records your current health status, measures your blood pressure, and asks about your angina symptoms.

    Based on a computer‑generated list, you are randomly assigned to receive either the nitroglycerin spray (containing glyceryl trinitrate) or a placebo spray that looks identical but does not contain the active drug. Neither you nor the study staff know which spray you receive; this is called a double‑blind design.

  2. Step 2

    Instruction on Spray Use

    You are taught how to use the sublingual spray, which means placing the spray under the tongue.

    Each dose consists of one spray delivering 0.4 mg of glyceryl trinitrate. The staff explains how often you should use the spray according to the study schedule (typically once daily as a preventive measure), and how to store it.

    You are also reminded that you may continue to use any rescue medication you normally take for an angina attack.

  3. Step 3

    Daily Administration and Diary Recording

    Every day you place one spray under your tongue at the prescribed time.

    You keep a diary in which you note the date and time you used the spray, any angina attacks that occurred, any rescue medication taken, and the blood pressure readings you measure on those days.

    If you experience severe angina that does not improve with your usual rescue medication, you must inform the study staff promptly.

  4. Step 4

    Week‑4 Follow‑Up Visit

    At the end of the fourth week you return to the clinic for a follow‑up visit.

    You complete the SAQ‑7 questionnaire, a short survey that asks about the frequency of angina, physical limitations, and quality of life.

    Your blood pressure is measured again, and the staff reviews your diary for any adverse events, low blood‑pressure readings (systolic below 90 mmHg), or need for additional anti‑anginal medication.

    Any safety concerns are addressed before you continue the study.

  5. Step 5

    Week‑8 Final Visit

    At the end of the eighth week you attend the final clinic visit.

    You repeat the SAQ‑7 questionnaire and undergo the same blood‑pressure measurements performed at week 4.

    The study staff compares your week‑8 results with the baseline and week‑4 data to evaluate the effect of the spray on your angina burden.

    All adverse events, episodes of low blood pressure, and use of additional medication are recorded.

    After this visit the study treatment is stopped and you are returned to your regular medical care.

  6. Step 6

    Study Completion

    You are informed that the trial has ended for you. No further study medication is provided.

    The study team may discuss the overall results with you once the trial is fully analyzed, but no specific treatment recommendations are given during the study.

Who can join the trial?

10 criteria

  • Be between 18 and 85 years old at the time you sign the study consent form.
  • Be able to read, understand, and sign the informed consent document that explains the study and its rules.
  • Have symptomatic coronary artery disease (CAD) – meaning you have heart‑blood‑vessel disease that causes symptoms – and have either unstable or stable angina (chest pain or discomfort caused by reduced blood flow to the heart).
  • Experience angina that is classified as CCS class I‑III (mild to moderate chest pain) or have a similar symptom such as shortness of breath.
  • Have waited at least 4 weeks after any previous heart‑blood‑vessel procedure called revascularization (such as opening a blocked artery) before joining the study, unless the previous procedure was not successful, in which case you may join sooner if you meet all other criteria.
  • Have a blockage (called stenosis) that is greater than 50 % in at least one coronary artery, as shown by a test called coronary angiography performed after any earlier revascularization.
  • Be judged by your doctor as not being able to have another revascularization because of the anatomy of your heart vessels (for example, very small vessels or a chronic total occlusion (CTO) – a complete blockage that cannot be opened).
  • Be able to tell the study staff the typical situations when your angina symptoms occur (for example, during exercise or stress).
  • Both men and women may join. Women who could become pregnant and men who have partners who could become pregnant must use reliable birth control methods during the study.
  • Have access to the internet using a smartphone, laptop, or tablet so you can fill out an electronic diary (eDiary) for the study.

Who cannot join the trial?

22 criteria

  • You have a type of chest pain that mostly occurs while resting, called vasospastic angina.
  • You have taken long‑term nitrate medicines (such as isosorbide mononitrate or isosorbide dinitrate) within the past 4 weeks, or you need to use short‑term nitrate medicines regularly (other than rescue use).
  • You are currently using medicines that stimulate soluble guanylate cyclase (used for high blood pressure in the lungs) or phosphodiesterase‑5 inhibitors (used for erectile dysfunction or lung hypertension).
  • You have had a recent episode of severe low blood flow, also known as shock or circulatory collapse.
  • You are pregnant or breastfeeding.
  • You are too frail to attend study visits, follow the treatment plan, or complete the electronic diary.
  • You have a thickened heart muscle that blocks blood flow, called hypertrophic obstructive cardiomyopathy.
  • You have moderate to severe heart failure (New York Heart Association class III or IV).
  • You have severe chronic obstructive pulmonary disease (COPD) – stage 3 or 4.
  • You have a stiff heart covering (constrictive pericarditis) or fluid buildup that squeezes the heart (pericardial tamponade).
  • You have serious problems with the heart valves (significant valvular heart disease).
  • Your blood pressure is very high (above 180/95 mmHg), which is considered uncontrolled hypertension.
  • Your heart is unable to pump enough blood, causing cardiogenic shock.
  • You have conditions that raise pressure inside the skull, such as brain bleeding or head injury (increased intracranial pressure).
  • You have taken part in another clinical study within the past three months.
  • You have low blood pressure with symptoms (systolic below 90 mmHg while lying down), known as pronounced symptomatic hypotension.
  • You have an irregular heart rhythm (atrial fibrillation) that leads to low and unstable blood pressure.
  • You have had a recent heart attack (acute myocardial infarction) with low filling pressure in the heart.
  • You have severe anemia (hemoglobin less than 8 g/dL) that caused chest pain in the past four weeks.
  • cerebrovascular disease) that could worsen with low blood pressure.
  • You have early‑stage glaucoma, an eye condition affecting the optic nerve.
  • You are allergic (hypersensitive) to nitroglycerin (glycerol trinitrate), other nitrate compounds, peppermint oil, or any of the other ingredients in the study medication.
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Investigated drugs

Nitroglycerin sublingual spray is a medication that is sprayed onto the inside of the mouth, under the tongue. It works by relaxing the blood vessels that supply the heart, which can help prevent chest pain (angina) in people with coronary artery disease. In this study the spray is given regularly before any symptoms start, to see if it can lower the overall amount of angina a patient experiences compared with a placebo.

What is already known about the treatment

Glyceryl trinitrate - This medication is given as an oromucosal spray that is placed under the tongue, allowing it to be absorbed quickly through the mouth lining. It is an established drug that has been used for many years to treat chest pain caused by reduced blood flow to the heart, and it is well documented in medical literature. It works by releasing nitric oxide, which relaxes the walls of blood vessels and improves blood flow to the heart. It belongs to the class of nitrate vasodilators, also known as anti‑anginal agents.

Investigated diseases

  • Coronary artery disease

    A condition where fatty deposits build up inside the walls of the heart’s arteries, gradually narrowing them and reducing blood flow. Over time the narrowing can become more severe, making the heart work harder to receive enough oxygen. This process often develops slowly and may be present for many years before symptoms appear.

  • Angina pectoris

    Chest discomfort or pressure that occurs when the heart muscle does not receive enough oxygen, usually during physical activity or stress. The episodes can become more frequent or last longer as the underlying artery narrowing progresses. Symptoms typically improve with rest, but the pattern of pain may change as the disease advances.

Trial detailsLast updated 2 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-525239-17-00Protocol codeP2301NLEstimated enrolment100 patientsSponsorG. Pohl-Boskamp GmbH & Co. KG

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