Is Symbicort A Rescue Inhaler?

Back in 2010, I wrote about the Symbicort SMART program, a groundbreaking approach approved in Europe that allowed Symbicort to be used both as a controller and rescue inhaler. The program permitted asthmatics to use it up to eight times per day, providing a flexible and effective way to manage symptoms. Not only was the program highly successful, but it was also proven to be safe.

Despite the enthusiasm in Europe for using Symbicort as a rescue inhaler, the U.S. FDA remained cautious, maintaining that "Symbicort should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm." (1)

This caution stemmed from outdated data suggesting that long-acting beta-agonists (LABAs), when used more than twice daily, were associated with an increased risk of asthma-related deaths.

I found this frustrating, especially knowing the success of the Symbicort SMART program and having personally used Symbicort as a rescue inhaler with good results—though I did this against my doctor's advice. Unfortunately, my insurance company would only allow one inhaler per month, based on outdated regulations. So, despite knowing how effective it was, I couldn’t use Symbicort in this way long-term due to antiquated insurance policies.

The idea behind using Symbicort as a rescue inhaler is that, during an asthma attack, you would benefit from both the fast-acting beta-agonist to open the airways and the inhaled steroid to reduce inflammation. This combination works better than a beta-agonist alone in both reversing and controlling symptoms -- according to studies. 

Thankfully, in 2017, the FDA finally approved Symbicort for use as a rescue inhaler. However, it took several more years for this information to be widely shared within the medical community. Even to this day, in the U.S., you rarely see physicians prescribe Symbicort as a rescue inhaler(2)

The FDA tends to move slowly when approving treatments that have already proven helpful in other parts of the world. Still, this was a positive development. A doctor friend of mine (a hospitalist) even said, "Don't be surprised if I start ordering Symbicort as a rescue inhaler." I found this impressive, as many doctors still don’t realize that Symbicort can open airways just as quickly as Albuterol.

One reason Symbicort may be superior to Albuterol is that, when you're experiencing asthma symptoms, you also get the added benefit of the steroid to control inflammation. Along with my doctor friend who mentioned he might start prescribing Symbicort as a rescue inhaler, my son's doctor echoed this advice. She told my son that, when experiencing asthma symptoms, he should use his Symbicort inhaler rather than Albuterol.

Since the FDA’s approval of Symbicort as a rescue inhaler, the makers of Albuterol have responded by developing an inhaler that combines Albuterol with an inhaled steroid. That inhaler is called AirDuo RespiClick, and it will be the topic of an upcoming post—so stay tuned!

References.

1. Package Insert for Symbicort prior to 2017, https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s013lbl.pdf, accessed 9/9/202
2. 1. "US FDA approves Symbicort (budesonide/formoterol) for the treatment of asthma in paediatric patients," Astrazeneca.com, 2017, January 30, https://www.astrazeneca.com/media-centre/medical-releases/US-FDA-approves-Symbicort-budesonide-formoterol-for-the-treatment-of-asthma-in-paediatric-patients-300120170.html#, accessed 9/9/2024

Should You Use A Spacer With Symbicort

Your Question. If you read the package insert for Symbicort, it says not to use with a spacer. What should we make of this? It seems to me that common sense would point to using a spacer with it, considering it is an inhaler. What do you think?

My Answer. That is a very good question. There are actually two ways of looking at this.

One, that Symbicort is still a relatively new product, and it has yet to have been studied with a spacer. For this reason, their lawyers may require them to make this note on the package insert.

Two, the dose of medicine is adjusted based on estimated distribution to the airways. It is well known
that only 9% of medicine inhaled by metered dose inhalers makes it to the lower airways where it is needed. To compensate for this low distribution percentage, the dose of Symbicort was adjusted to obtain maximal results. Wanting to limit side effects, the makers of Symbicort (AstraZeneca) and their lawyers decided to put the disclaimer on the package insert that a spacer should not be used.

So, you might be thinking, so why then should you not use a spacer? The general thinking is that a spacer would improve coordination, reduce side effects, and improve distribution. A spacer will surely reduce impaction of medicine particles in your upper airway, thereby reducing side effects. However, these medicine particles cause systemic side effects only after they are swallowed. These medicine particles are broken down (metabolized) by the liver, where almost all of them are excreted in urine. Only a tiny fraction gets into your bloodstream and has a chance to cause systemic side effects. This is called first pass metabolism, meaning that your digestive tract and liver significantly breaks down the medicine before it reaches your circulation.

Now, let's look at the medicine that makes it to your airways. Studies show that 10-40% of this medicine will come into contact with blood vessels in your lungs. If you use a spacer and increase lung distribution, that means that you are getting more medicine to airways. You'd think this is a good thing, resulting in better asthma control (although modern studies can even debate that). However, while true, it also increases the amount of medicine that comes into contact with pulmonary blood vessels. These medicine particles do not participate in first pass metabolism. Instead, a majority, if not all, of these particles directly enter your circulatory system, where they might participate in systemic side effects.

So, while a spacer might improve coordination and reduce side effects, not using a spacer may reduce side effects even more so than using a spacer. This is important, because this is how pharmaceuticals like AstraZeneca prevent side effects from corticosteroids and long-acting beta adrenergic medicines.

Bottom line, the dose of Symbicort is adjusted to account for a lung distribution of only 9%. If it were assumed that 100% of patients used a spacer with Symbicort, then the dose of the medicine would be adjusted downward to compensate for the improved lung distribution. This would be necessary to prevent side effects. So, I know this was a complicated explanation, but might explain why the package insert for Symbicort recommends that no spacer be used.

So, what should you do? Personally, where I work we distribute spacers with all inhaler products. I think this is the way it will be done until the medical profession adjusts to this new wisdom. For legal and ethical purposes, I think following your hospitals policy is the best policy. However, when you are using your own inhaler product, whether you use a spacer is up to you.

References.

“A Guide for Aerosolized Delivery Devices for Respiratory Therapists,” 3rd edition, https://www.aarc.org/education/online-courses/aerosol-devices/, accessed 8/4/17

Irwin, et al., “Side Effects With Inhaled Corticosteroids,” Chest, July, 2006, http://journal.chestnet.org/article/S0012-3692(15)32956-1/pdf, accessed 8/3/17

“Spacers with inhalers: Do they make a difference,” American Academy of Allergy, Asthma, and Immunology, 2017, Jan. 18, https://www.aaaai.org/global/latest-research-summaries/New-Research-from-JACI-In-Practice/spacer-inhaler, accessed 8/5/17

Saag, Kenneth G., et al., “Major Side Effects of Glucocorticosteroids,” 2017, https://www.uptodate.com/contents/major-side-effects-of-inhaled-glucocorticoids, accessed 8/3/17

Barnes, Peter, J., "Inhaled Corticosteroids," Pharmaceuticals (Basal), 2010, March 3, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4033967/, accessed 8/1/17

Romme, “Fracture Prevention in COPD: A clinical 5-step approach,” Respiratory Research, 2014, https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-015-0192-8, accessed 6/20/17

Is Symbicort safe?

Your Question:  I'm an asthmatic and have been taking Symbicort for three days, one puff twice a day.  Should I keep using it or stop?  From what I've read, I am afraid about side its side effects and that it may cause asthma-related death. 

My answer:  Your physicians prescribed this medicine because he believes the benefits outweigh the risks. It is a very good medicine for controlling and preventing asthma, and  is a top line asthma medicine. 

and, so long as it is used as prescribed, is considered safe. I wrote an article about just this topic a few years ago, and I will link to it here for you to review. If you have further questions please feel free to ask.

Symbicort as a rescue inhaler

Last week I wrote about how I think that Advair and Symbicort get a bad rap due to fears that the long-acting bronchodilators in them (Serevent and Formeterol) have been linked to asthma deaths. Yet, in U.K., scientists have found Symbicort to be safe enough to approve it to be used not just as a preventative medicine, but as a rescue inhaler too.

It's called the SMART program, and you can read about it by clicking here.

According to asthmansw.org, SMART is an acronym for "Symbicort Maintenance And Reliever Therapy." The SMART program is explained here:

"It is a daily asthma management approach that allows you to use a single Symbicort inhaler as both a preventer and a reliever. Currently Symbicort is the only medication available for use as BOTH a maintenance preventer and reliever.

SMART works this way as it contains 2 different types of medicine in the same inhaler – a preventer (Pulmicort [Budesonide]) as the long acting reliever which helps to control redness and swelling in the airways, and a reliever (Oxis [Eformoterol]) which can not only work quickly, but can also last a long time.

A person using the SMART approach to manage their asthma would take a maintenance dose of Symbicort, usually morning and night to maintain or establish asthma control AND they would also take additional inhalations of Symbicort as needed to relieve symptoms.

SMART is suitable for all people aged 12 years or older who are currently recommended to take combination medication for their asthma.

You can see that so long as the long-acting bronchodilator is deemed as safe to be used more than twice a day, it provides the patient with an extra dose of steroid each time a rescue inhaler is used. This basically allows the patient to increase his corticosteroid when he's having trouble with his asthma, and decrease it when he's doing well. In this way the asthmatic has more control

Thus, "Studies have shown that people using Symbicort SMART – an additional way of taking the existing Symbicort inhaler - took no extra inhaled steroids and needed fewer oral steroids compared to traditional treatment methods. They also experienced fewer asthma attacks."

An Astra Zeneca sponsored study (the makers of Symbicort) noted the SMART program resulted in a 28% reduction in severe exacerbation compared to a regimine of using Symbicort twice a day while using something like Ventolin as a rescue inhaler in between.

The use of Symbicort in this manner in the U.S. is presently being reviewed by researchers.

Advair/Symbicort: Is overuse really dangerous???

Warning: The following post is meant to make you think, and perhaps give you something to discuss with your doctor. Please do not change your asthma regime without first consulting your physician.

There has been much hype the past several years regarding the safety of long acting bronchodilators such as serevent (which is also a component in Advair) and formoterol (which is also a component in Symbicort). In fact, there was once a threat that the FDA would take this medicine off the market.

Some reports say these medicines are linked to worsening asthma and even death, such as this warning about Advair from MyAsthmaCentral.com:

"University of Iowa researchers have added their voices to growing warnings about Advair, saying that drugs that use salmeterol in combination with an inhaled corticosteroid can make asthma more severe or even fatal."

Or this warning regarding Symbicort:

"Rarely, serious (sometimes fatal) asthma-related breathing problems may occur in people with asthma who are treated with drugs similar to the formoterol in this product (long-acting inhaled beta agonists). "

Studies have been conducted to determine if it is the medicine itself that is causing asthmatics who use it to die? Or is it the fact that these patients are overusing it?

I think these folks are all wrong. I think they are so pent on looking in one direction that they fail to see the big picture. I say this because I do not believe overuse of Serevent is what causes most people to die

I believe what causes most people to die of asthma when they are on Serevent (or a similar such drug) is the fact that instead of seeking help they clutch to the inhaler seeking relief. Instead of controlling their asthma, instead of talking to their doctor or calling an ambulance, they stay home thinking they are going to get "relief" from the inhaler in their hand.

What they lack, really, is proper education.

I can say this because I have had COPD and asthma patients who have overused their Advair or symbicort inhalers. I have accidentally taken extra puffs of mine too, and even while I was a bit nervous about it for a while due to the "scare," nothing happened. My heart never stopped.

I think long-acting bronchodilators do not kill. I think overuse of long-acting bronchodilators does not kill. I think what kills is poor asthma control. What kills is the false belief you are going to get relief from your inhaler when what you should be doing is getting your butt to the ER.

This does not just go for long-acting bronchodilators either. I've seen reports of Ventolin getting a bad rap because some asthmatic dies with the inhaler in his grasp. The report notes: "Asthmatic dies from Ventolin overdose?" Really? You think so?

Back in the 1980s Alupent was deemed such a safe medicine by the FDA that it was made to be legal to sell over the counter. I remember my mom going to get me an inhaler and just grabbing one off the shelf. But shortly after this ruling seven asthmatics died of asthma while clutching their Alupent inhalers. So did poor asthma management get the blame? No! What got the blame was the Alupent. The patient abused the inhaler because it was so easy to get, and soon thereafter Alupent was taken off the shelves.

I'm not proposing that all asthmatics go out and start using their Advair or Symbicort more than they currently do. What I am proposing is that instead of blaming the medicine used to treat asthma, that doctors and scientists and scaremongers spend more time educating asthmatics instead. Let's stop scaring people away from the asthma medicines that work the best, and start educating them how they can manage their asthma and prevent themselves from getting so bad that they'd clutch an inhaler to their deaths in the first place.

For most asthmatics, one puff twice a day of Advair or a similar regime of Symbicort works just fine. For most asthmatics, if you need to use your Ventolin or Xopenex more often than three times in a week your asthma is not controlled, and you need to work with your asthma doctor to get your asthma controlled. You can do it.

Yet there are some asthmatics whose asthma is more severe and who need to use their rescue medicine more frequently. And it's for patients like this who may find a scientifically proven benefit from using medicines like Serevent and Formeterol more frequently. Which is why further open minded studies are relevent.

Yet due to the fear of death and lawsuits American companies fear advancing this research, and the FDA continues to send out warnings that serevent and formoterol are linked to fatal asthma. However, to give the FDA credit, it likes to wait until a medicine beyond a reasonable doubt is safe for patient use.

That said, I have learned that in Britain and Canada Symbicort has been approved to be used not only as a preventative medicine, but as a rescue inhaler. It's called the SMART program. Stay tuned, because next Tuesday I will discuss the SMART program, and discuss whether this, or a similar program, would be good for American asthmatics.

New drug combo may greatly benefit COPDers

I had an uncle with COPD call me about a year ago because he wanted to learn ways he could improve his lung function. Basically, I gave him three recommendations off the top of my head:

1. Stop smoking

2. Stay as active as you possibly can

3. Take all your lung medicines exactly as prescribed

4. Talk to your doctor about Spiriva.

I told him I had read about studies that proved Spiriva improved lung function in COPD patients. He heeded my advice, but he passed away before I could talk to him about how it worked for him.

A new study released this past month shows not only does Spiriva improve lung function in COPD patients, if it is used in conjunction with Symbicort. According to an article at medicalnewstoday.com, the combination of Spiriva plus budesonide/formoterol combination (the contents of Symbicort):

• Reduced the rate of severe exacerbations by 62% (p<0.001)2
• Improved clinical lung function as measured by improvement in pre and post dose FEV1 (p<0.001,>
• Improved morning symptoms and activities (p<0.05)
• Improved health-related quality of life
• Was well tolerated

Typically, according to the above article, a combination of a long acting bronchodilator and corticosteroid and Spiriva is indicated in any COPD patient with a lung function (FEV1) of less than 50%.

So this is all the more reason to keep in touch with the latest research. If your doctor is unaware of this study, perhaps you'll want to nudge him.

However, keep in mind this is just one study, although one that showed significant improvements in lung function with those taking the trio of medications compared to those who received a placebo.

While there is no cure for COPD, the goal of therapy is to make sure all COPD patients are able to remain productive members of society. Aside from avoiding cigarette smoke and staying active, new medicines can help COPD patients accomplish the goal of maintaining a quality of life.

Flutiform to compete with Advair & Symbicort?

In my perusal of the health news world today I found this article about a New asthma drug that is probably going to hit the market soon. It's a medicine that will compete with Advair and Symbicort. This is good news, I think, for chronic lungers.

This new medicine is called Futiform. Like Advair and Symbicort, it's a combination dry powder inhaler with both a long acting bronchodilator and a corticosteroid. It seems to be a copy cat medicine with the intent on profiting on the latest craze in asthma medicines that aim to treat both the major components of asthma: bronchospasm and chronic inflammation.

I should mention here that the FDA recommends that if a long-acting bronchodilator is prescribed for asthma an inhaled corticosteroid should also be prescribed to treat the underlying chronic inflammation of the air passages in the lungs.

In this sense, combination inhalers such as Advair and Symbicort are a recommended and common treatment for asthma. And, perhaps soon, we can even add Futiform to this list.

The interesting thing here is that while Futiform is a new medicine per se, neither of the medicines it is composed of are new. The corticosteroid in Futiform is Flovent, the same corticosteroid that is in Advair. The long-acting bronchodilator is Formoterol, the same that is in Symbicort.

In my lifelong experimentation with corticosteroids, I have found that none works better than Flovent. My pharmacist insists it's not any better than the other such steroids on the market, but I beg to differ. I have many asthmatic friends who feel the same way.

Serevent, the long acting bronchodilator in Advair, is a medicine I have often wondered about. While I've been using my Advair compliantly for over 2 years, I still have to use my rescue inhaler a few times a day. Of course that's not bad, but it could be better.

Serevent does not provide quick relief for asthmatics, however I have learned that formoterol does. Therefore, and I'm just speculating here, I'm wondering if perhaps formoterol is a better medicine than Serevent.

Thus, I'm wondering if this new medicine combines the best corticosteroid (Flovent) with the best long-acting bronchodilator (formoterol). If that's the case, this product should do pretty well in the world market at least until a better medicine is invented.

Of course, like you, my job as a gallant asthmatic is to always be thinking along these positive lines. We are constantly on the look out for that new asthma medicine that might help us get that much better control of our asthma. If nothing else, this "probable" new medicine may provide another option for us chronic lungers to try.

On a side note here, I don't like to be a Guinea pig for new medicines, but both Flovent and Formoterol have been on the market long enough to know they are safe if they are used only as prescribed.

Oh, and one more thing, the article referred to above mentioned something about generic forms of Advair and Symbicort perhaps hitting the market soon. It'll be interesting to see how this option benefits us asthmatics.

Whether or not the generic forms will be as efficatious as the original may always be up to debate, but a lesser expensive Advair and Symbicort might be the best thing to happen to us asthmatics during an economic downturn.

Well, we'll see.

Thoughts about Advair and alternatives

As I blogged about yesterday, many people have been asking about alternatives to Advair and Symbicort due to the high cost of these meds. I have listed some options here on this blog as they've come to me.

Today I have another option that has popped into my always thinking head. I'm a very curious person, and therefore sometimes I find myself thinking of things other people may never have considered. I'm not saying they'll work, I'm just thinking here.

It's something that's far out there, but actually it isn't. Since Advair** is an expensive mixure of a corticosteroid (Flovent) and long acting bronchodilator (Serevent) meant to treat both the chronic inflammation and prevent acute bronchospasm, why can't a mixture of less expensive meds be used as a replacement for Advair.

Of course Advair is the asthma wonder drug of choice not just because of what it prevents, but because it's easy to carry around, easy to use, and only needs to be taken twice a day. It's highly convenient, and makes asthmatics much more compliant than in years past. If cost were no obstacle, Advair is the medicine of choice.

The only problem with Advair (aside for some minor side effects), is that it costs an arm and a leg. And, since it costs so much, people who do not work, are poor, or have no health insurance have no way of gaining access to it. And it's these people we see in hospital emergency rooms.

So, as a replacement for an Advair discuss that costs $120 a month, why can't Asthmatics (and COPDers too), take Vanceril at $38 a month and Ventolin, which costs $42. That's still a chunk, but it's $40 less than Advair.
I can see a doctor switching a patient from Advair to Vanceril or some other generic corticosteroid (like Azmacort, Beclovent, Aerobid, etc). But instructing every asthmatic to take Ventolin every four hours is frowned upon. Why?

The asthma guidelines themselves say that any asthmatic who needs Ventolin more than 2-3 times in a two week period does not have control of his asthma. If that is true, then why are people who need Serevent in their systems all the time considered under control? Aren't they the same type of medicine, except one lasts for 12 hours and the other 4-6?

And yet, while the asthma guidelines recommends Advair and frown upon overuse of Ventolin (overuse would consist of using it more than the asthma guidelines recommend), it seems every single patient admitted to the hospital with Asthma or COPD is given Ventolin*** every 4-6 hours regardless of whether their disease is exacerbated. Ventolin lasts in the system about that long.

So a wise man asks: Why is it okay to order Ventolin every four hours as a preventative medicine in the hospital, but not okay to order it the same way for outpatient therapy?

A doctor recently gave me an answer when I questioned why she keeps ordering Ventolin Q4 on all her patients. She said, "Because they need it in their system to prevent shortness of breath."

Okay? So, if a patient needs it in his system while in the hospital to PREVENT shortness of breath, then why does this philosophy not apply outside the hospital? Either Ventolin is a preventative medicine or it is not?

It would seem to me if a patient does not respond well to Serevent, then Ventolin is a viable option. Of course you must consider what works for one patient does not work for all.

Personally, I don't think Ventolin prevents anything for most patients. The pre-use of Ventolin has never prevented me from having a bronchospasm. However, the pre-use of a corticosteroid has. However, I'm not saying Ventolin won't prevent for some patients.

I know Ventolin doesn't prevent for me because I had a pre and post PFT done to prove this. But doctors rarely order PFTs to determine if the Ventolin they are ordering on all their patients is working.

That would make too much sense. Better sense would be to use common sense and not order ventolin at all unless it is needed, or at least proven to be effected, which could be a subjective or objective measure.

But actually assessing to determine effectiveness would mean an actual assessment, which would be way to much work for some doctors to bother with. So they just order what feels right, not what is right (Kind of like Washington Politics, hey!).

I suppose you can create a third angle with this argument. If Ventolin should never be used unless a patient is having an exacerbation, then Serevent should never be used period. If the corticosteroid is doing its job, the patient should never get short of breath in the first place.

Yet that may not be a reasonable claim for many patients. Still, Serevent and Ventolin are the same medicine. And, while a patient is taking Serevent on a daily basis, it is still considered safe to use Ventolin with Serevent ( but never safe to use Serevent more than twice a days).

So, if you still need to use Ventolin every day regardless of being on Serevent, is the Serevent even doing it's job? Is it really preventing bronchospasm?

Or, is the reason Advair improves the lives of asthmatics so much more do do with the fact it's easy to use, convenient to carry around, and only needs to be taken twice a day, and not because it has both a corticosteroid and long acting bronchodilator. In other words, would a discus of Flovent alone work as well as Advair?

If the answer is yes, then any patient on Advair that costs $120 could easily be switched to a medicine like Vanceril which costs $38, and not lose any of the benefits. However, there would be one big if here: the patient would have to be as compliant with the Vanceril inhaler as he is with the Flovent discus.

Vanceril may be needed 4 times a day instead of the convenient two. Plus those patients who are now taking Vanceril will also have to lug around a bulky spacer. Obviously we're supposed to carry one around with our Ventolin too, but you and I both know most asthmatics (especially guys) don't carry spacers with them.

Ideally, Advair is better all the way around, except for cost. But, if you are strapped for money, perhaps an alternative generic corticosteroid may work just as well as the Advair, if proper technique is used. That means you have to use a spacer.

And perhaps, if you or your doctor thinks Serevent works so well for you, then why not take Ventolin every 4-6 hours round the clock too, regardless of what the guidelines say.

If I haven't lost you with my rambling here, tell me where you think I'm wrong (or right).

* costs listed are estimates.
**Advair and Symbicort are basically the same med, so when I refer to one, I'm also referring to the other.
***Xopenex may be ordered as well, and if it is the frequency is usually every 4-8 hours because that's how long the medicine lasts.