People with chronic obstructive pulmonary disease (COPD) often need to use many different inhalers every day to help them breathe better. But now, there are newer inhalers that combine different medicines into one device. These are called long-acting combination inhalers. Instead of using multiple inhalers several times a day, some people can now use just one inhaler to keep their breathing problems under control. This makes it easier for people to take their medicine and helps them feel better.
One of these new inhalers is called Breztri Aerosphere. You may hear this called “triple therapy.”
How Does Breztri Aerosphere Work?
COPD is a long-term (or chronic) condition of the lungs that can make it hard to breathe. COPD is an umbrella term that includes two conditions: emphysema and chronic bronchitis. Some people with COPD have emphysema, some have chronic bronchitis, and some have both conditions. In emphysema, the air sacs in the lungs become damaged and are less able to pass oxygen into the bloodstream. Air can also become trapped in the damaged air sacs, making it harder to breathe over time. In chronic bronchitis, swelling (inflammation) causes the airways to become narrowed. It also causes mucus to build up, clogging the airways.
People with mild COPD may not have any symptoms. But COPD is a progressive condition, which means that symptoms will get worse with time. As COPD worsens, symptoms can include coughing, bringing up mucus, trouble breathing or taking a deep breath, wheezing, and tightness in the chest.
People with COPD may experience a flare-up (or exacerbation). COPD flare-ups can last for days to weeks and may involve coughing more often, bringing up more mucus, having more trouble breathing, and feeling more tired. Although COPD flare-ups have many different causes, some of these flare-ups are caused by certain triggers. Examples of common triggers are:
- Cold air
- Dust
- Infections
- Pollen
- Smoking or inhaling smoke
- Strong smells
- Sudden temperature changes
The key to treating COPD is to control symptoms, reduce the amount of swelling in the lungs, and open the airway. This makes it easier to breathe.
Breztri Aerosphere contains three medicines that reduce swelling and relax the muscles in your airways.
- Budesonide is a medicine that reduces swelling. It is an inhaled corticosteroid (ICS). It helps make it easier to breathe and reduce coughing.
- Glycopyrrolate is a medicine that relaxes the muscles in the airways. It is an anticholinergic medicine. You may hear it called a long-acting muscarinic agent (LAMA). It works a little slower and can last up to 24 hours. It helps with long-term control of your COPD flare-ups.
- Formoterol fumarate is another medicine that helps the muscles in the airways relax. It is a long-acting beta-2 agonist (LABA) medicine. It starts working faster, so it can help when you are active.
Glycopyrrolate and formoterol are both bronchodilators. These two medicines work in different ways to relax the muscles in the airways.
Can Breztri Aerosphere Be Used Alone for COPD?
For some people with COPD, this will be the only inhaler they need to use every day to control symptoms. Do not use other long-acting daily inhalers unless your health care provider says that you should.
You should always have access to a rescue inhaler. An example is albuterol. These inhalers give quick relief of symptoms when you are having sudden trouble breathing. Breztri Aerosphere is a maintenance inhaler that should only be used to prevent COPD symptoms. It is not used to manage sudden breathing issues.
How Should I Use This Medicine?
You inhale two puffs in the morning and two puffs in the evening. After two puffs, rinse your mouth with water and spit the water into the sink. This is important to lower your chance of getting a yeast infection in the mouth or throat, called oral thrush. Shake the inhaler well before each use.
It is important for you to use the inhaler properly so that you get the right dose. Your prescription should come with instructions for use, which explains how to prepare your dose, inhale your medicine, and when to refill your inhaler. For example, you should not open the cover of the inhaler until you are ready to use it or you may lose a dose. Ask your pharmacist or other health care provider if you are unsure how to use your inhaler.
How Was It Studied for COPD?
Two studies (ETHOS and KRONOS) were done to see if Breztri Aerosphere was safe and effective for treating COPD. Everyone had COPD, was taking at least two maintenance medicines, and was at least 40 years old. The average age was 65, with most people being male. They had all smoked at some point in their lives, and some were still smoking at the time of the study.
Both studies compared Breztri Aerosphere with inhalers that have two of the medicines in Breztri Aerosphere, glycopyrrolate and formoterol fumarate [GFF] and budesonide and formoterol fumarate [BFF]. They did not know whether their study inhaler had two or three medicines. If a person had sudden trouble breathing, they were told to use their rescue inhaler.
- In the ETHOS study, people also had to have COPD flare-ups in the past 12 months. Efficacy was measured by the number of moderate or severe flare-ups that happened during the study. People were told to use their inhalers twice a day for 12 months.
- In the KRONOS study, efficacy was measured by asking people to take a deep breath and then force as much air out of their lungs as possible. The amount of air that a person could force out of their lungs in 1 second was recorded. This measure helps to understand how well the lungs are working. People were told to use their inhalers twice a day for 6 months.
- These studies looked at COPD symptoms and how they impacted daily activities by using surveys that measured how well the treatment is working. This also included how often people needed to use their rescue inhalers.
What Benefits Were Seen in the Studies?
Moderate-to-severe COPD flare-ups. Both studies counted the number of moderate to severe flare-ups that happened during the study. A “moderate” flare-up meant that a person needed to take antibiotics and/or a corticosteroid medicine. A “severe” flare-up meant that a person had to be admitted to the hospital or died. People with or without a history of flare-ups who used Breztri Aerosphere had fewer moderate/severe flare-ups and a longer time to flare-up than people who used the inhalers with only two long-acting medicines.
Breathing. The KRONOS study showed that people who used Breztri Aerosphere were able to force more air out of their lungs than people who used the other inhalers. This improvement started on the first day of the study and lasted to the last day. This means that people were able to move air through their lungs more easily.
COPD symptoms. People in these studies completed surveys to help see how their COPD symptoms were affected. One of the surveys asked patients how often their symptoms happen, including how often they cough, have mucus, have trouble breathing, wheeze, or have chest tightness. It also asked patients how severe these symptoms were, and how much they got in the way of daily activities, such as washing, dressing, walking, household chores, yard work, and more. In both studies, people who used Breztri Aerosphere were more likely to have improvements in their symptoms than people who used inhalers with only two long-acting medicines.
Use of rescue inhalers. The studies looked at the number of days that people used their rescue inhalers. In the ETHOS study, people who used Breztri Aerosphere had fewer days where they used their rescue inhalers compared with the people who used only two long-acting medicines.
Your results may differ from what was seen in clinical studies. You and your health care provider should determine if the benefits outweigh any potential risks.
When Does the Medicine Start Working?
When these three medicines work together, it may be easier to breathe, you may cough less or have fewer breathing problems, and you may be able to do more activities without getting out of breath. For some people, this might mean that there will be fewer sudden breathing issues and that you will not need to use your rescue inhaler as often. You should see these changes in a few days to weeks.
Do not stop using Breztri Aerosphere without talking to your doctor first, even if your breathing has gotten better. Your breathing may get worse again once you stop it. Improvements can be different for each person, so it is important to track your symptoms and review with your health care provider.
Tell your health care provider if you do not think that your symptoms are improving after a few weeks. Your health care provider may ask you to show them how you use your inhaler to be sure you are using it properly. Otherwise, you and they can discuss other options for treating COPD.
Contact your health care provider right away if your breathing problems get worse or if you need to use your rescue inhaler more often than before starting Breztri Aerosphere. You should also contact them right away if your rescue inhaler doesn’t seem to work as well as it did before.
How Can I Prevent and Manage Side Effects?
The most common side effects are infections of the airways. These can include infection in the nose or throat, a sore throat, or common cold symptoms. This can also include lung infections, such as bronchitis or pneumonia. You should also avoid being around chickenpox or measles. The best way to prevent infection is to reduce your exposure to germs by washing your hands and avoiding people who are sick. You should stay current on vaccinations, such as getting an annual flu vaccine. Call your health care provider if you have the following symptoms of infection:
- Fever or chills
- Body aches
- Cough
- Tiredness
- Persistent headache
- Confusion
- Vision changes
- Painful rash
- Painful or frequent need to pee
You can sometimes get a yeast infection in the mouth or throat called oral thrush. The best way to prevent this infection is to rinse your mouth with water after each dose and then spit the water into the sink. Always use good oral hygiene including brushing your teeth twice a day and rinsing/cleaning your dentures. If you think you have oral thrush, do not stop using your inhaler. Call your health care provider if you have any of the following symptoms of thrush:
- White spots in your mouth, including your tongue, inner cheek, or throat
- Redness or soreness in your mouth
- Changes to taste
- “Cotton-like” feeling in your mouth
- Pain or difficulty when swallowing
Long-term use of medicines that contain inhaled corticosteroids may weaken and thin your bones. This is measured by a bone mineral density scan, which measures the strength of bones. Although the risk of this is small with inhaled corticosteroids, certain people may be at higher risk, like older adults or people who already have weak bones. Talk with your health care provider about ways to maintain good bone health, including calcium and vitamin D supplements, weight-bearing exercises, and bone mineral density scans.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Types of Interactions Can Happen?
Several medicines can affect the blood levels of the ingredients in Breztri Aerosphere, which could increase the risk of side effects. Tell your health care provider if you are taking the antibiotic clarithromycin, any medicines for HIV, or any medicines for a fungal infection. Also tell your health care provider if you are using any medicines for heart problems or blood pressure.
Many other inhalers for COPD contain medicines that are the same as or like the medicines in Breztri Aerosphere. You may need to stop an inhaler that you were taking before if you switch to Breztri Aerosphere. Talk with your health care provider if you are unsure which inhalers to use daily or as needed.
This is not a complete list of medicines that may interact with Breztri Aerosphere. Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions, or if you need a dosage adjustment.
Getting Your Medicine: What to Expect
Breztri Aerosphere can be prescribed by your primary health care provider or pulmonologist. Before you start treatment, your health care provider or pharmacist can review the instructions on how to use your inhaler each day and how to clean your inhaler. You can find out more at www.breztri.com/administration/using-your-inhaler.
There is a co-pay assistance program from the manufacturer that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.breztri.com/savings-support/zero-pay-program or by calling 833-458-0440.
