Launch of Symbicort Turbuhalerfor the Treatment of Adult Bronchial Asthma in Japan

Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) and AstraZeneca K.K. (headquarters: Tokyo; President and CEO: Masuhiro Kato) announced thatSymbicort® Turbuhaler® 30 doses and Symbicort® Turbuhaler® 60 doses (generic name: Budesonide/Formoterol fumarate dihydrate) for the treatment of adult bronchial asthma will be launched on January13, 2010 in Japan.

Symbicort® Turbuhaler® is a twice-daily treatment for adult bronchial asthma combining budesonide, an inhaled corticosteroid (one dose containing 160μg) and formoterol fumarate dihydrate, a rapid and long acting β2 agonist (one dose containing 4.5μg), and the product is administered by an inhaler (Turbuhaler).

Characteristics of Symbicort® Turbuhaler® are as follows:
-The Product alone shows good efficacy in countering both of the causes of bronchial asthma, airway inflammation and airway narrowing
- By administering two medications in one product, in addition to the convenience for controlling bronchial asthma, due to the fast onset of bronchial dilation effect of formoterol, patients can easily feel the effect of the treatment. As a result, improvement in adherence (continuation of treatment) can be expected.

Symbicort® Turbuhaler® was listed as a new option for long-term maintenance treatment on “Asthma Prevention and Management Guideline 2009, Japan” which was revised in October 2009.
The guideline recommends that Symbicort® Turbuhaler® can be used for the treatment from step 2 to step 4 as the combination therapy combining an inhaled corticosteroid and a rapid and long-acting β2 agonist.

Symbicort® Turbuhaler® was first approved in Europe in 2000, and is now approved in more than 100 countries and regions. The product will be manufactured and developed by AstraZeneca K.K. and distributed and sold by Astellas Pharma Inc., while promotion will be jointly carried out by both companies (co-promotion).

P.S. Prevent asthma attacks by eating Vitamin C and Vitamin D rich foods and fruits.

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What is Chronic Obstructive Pulmonary Disease

COPD (Chronic Obstructive Pulmonary Disease) is a chronic disease of the lung that covers several conditions including Chronic Bronchitis or Emphysema.

Chronic Bronchitis results from an inflammation of the airways of the lung. The term chronic refers to the fact that the condition is present for a long time and bronchitis means inflammation of the bronchi or air passages of the lung. You can find the anatomy of the lung on any well-researched website, but I will give a brief summary here.

The air passages begin with the trachea in the neck which branches into the left and right main stem bronchi. These bronchi continue to branch into smaller bronchi or bronchioles until they end up in the microscopic air sacs or alveoli. It is the alveoli that oxygen and carbon dioxide are exchanged with a rich network of small blood vessels or capillaries. The bronchioles and bronchi are responsible for delivering the oxygen to the alveoli and for carrying the carbon dioxide from the alveoli to the outside. These air passages are more than just tubes — the linings are composed of cells and structures that serve many functions for lubricating the airways and removing debris from the airways. These cells can be damaged by infections or toxins like inhaled poisons or smoking. When these cells are irritated by various stimuli, they form mucus which can plug up the airways and make air movement difficult. In addition, the airways have muscles in the walls and these muscles will contract or dilate the airway depending on what kind of pressure is placed on them.

When we breathe in, our diaphragmas act like an accordion and pull air into the airways. When we breathe out, we squeeze our chests and the airways by pushing our diaphragms up to force the air out. This pressure to force the air out causes the bronchi to become narrow and slows down the speed of the air escaping from the lungs. If the airways are already partially blocked by mucus, or if the muscles are contracting due to irritation, the air cannot escape from the lungs as well, and we feel short of breath or you will hear a wheezing sound as the air tries to escape through narrow tubes.

Emphysema, on the other hand is a disease of the alveoli or air sacs, where the lining of the sacs become destroyed by specific enzymes or infections, and the small air sacs become larger and larger as the walls or membranes between them become destroyed. They tend to lose their elasticity and are unable to squeeze the air out of them as effectively. In addition, the walls or membranes contain the capillaries or small blood vessels that carry the oxygen to the tissues and remove the carbon dioxide from the tissues, so air exchange becomes compromised and we feel short of breath, because not enough oxygen is being delivered to our tissues. In severe cases we can actually see our fingernails turn blue from lack of sufficient oxygen. When there is not enough oxygen in the blood, the blood becomes dark or blue, like in our veins. When there is enough oxygen in the blood the blood becomes a bright red, like in the arteries.

Chronic Obstructive Pulmonary Disease or COPD is a combination of Chronic Bronchitis and Emphysema. The treatment is therefore three fold.

* Remove the toxins from the lungs. This is done by avoiding irritants like smoke, perfumes, dust, or allergens from the environment. In addition, direct toxins like cigarette, cigar or pipe tobacco smoke should be immediately discontinued.

* Treat the constriction of the airways with medicines that can open up the airways. These are called bronchodilators and are usually in inhalers or nebulizers, but can also be in cough medicine, or pills.

* Treat the inflammation of the airways with inhaled anti-inflammatory medications, or by pills or injections. These medications are derivatives of cortisone. Frequently in severe episodes you will be treated with doses of Prednisone tablets for short period of time, or injections of cortisone.

The treatment of COPD is therefore a combination of bronchodilators and cortisone as well as discontinuing smoking, treating any infections and avoiding an environment of smoke.

The prognosis varies depending on the severity of the condition, and this can be determined by doing pulmonary function tests to see how well you can breathe. A simple test that can be done in the office is the PEFR (Peak Expiratory Flow Rate). This is a simple flow meter that patients with COPD can obtain from the pharmacy to test the amount of airway restriction that is present. A more detailed test can be done by a pulmonary specialist, which we do have here in Nassau.

If caught early enough, like any other disease, the prognosis is excellent. I have seen patients with severe COPD who require oxygen all the time, still smoke even with the oxygen being administered. Those are extreme cases but, as you can see, the prognosis can vary widely depending on the severity of the disease and the compliance of the patient with prescribed treatment.

P.S. boost your asthma immunity by eating Vitamin C and Vitamin D rich foods and fruits.

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H1N1, asthma can be a dire combination in children

The day before Halloween, T.J. Berndsen had what his parents believed was a little asthma flare-up. By Halloween night, he felt lousy enough to cut trick-or-treating short.

A week later, the 9-year-old was straining to breathe in the emergency room at Cincinnati Children's Hospital Medical Center because of complications from an H1N1 influenza infection.

"By Sunday, Nov. 8, his cough turned into a croupy bark, and he started running a fever. It got to 102.9. I knew it had gotten to be more than we could handle at home," says his mother, Jennifer Berndsen. She had suspected flu but wasn't sure. His school had had significant numbers of children out, but his classroom hadn't seemed to be hit hard, she says.

While H1N1's effects in a healthy child can range anywhere from mild congestion and sore throat to serious respiratory illness, and even death, the 7 million American kids who have asthma are at a higher risk for complications and death if they contract the novel flu virus, says Tom Skinner of the Centers for Disease Control and Prevention.

"We're seeing underlying health problems, including asthma, in about two-thirds of the estimated 540 children who have died from H1N1 complications," he says.

But the CDC and pediatric asthma experts say there are steps you can take to prevent H1N1, or swine flu, as well as seasonal flu, and ways to treat it if an infection does occur.

Prevention is best

"In children with asthma, the key issue is anticipation rather than reacting," says Erwin Gelfand, chair of pediatrics at National Jewish Health in Denver, a hospital that specializes in treating children with respiratory conditions.

Gelfand says a parent can ensure two things: vaccination and making sure a child's asthma is in control.

The advice goes even for children who get asthma only intermittently, says Tyra Bryant-Stephens, medical director of the Community Asthma Prevention Program at Children's Hospital of Philadelphia.

"Children who only get asthma during exercise, with a cold, or during allergy season can also have serious complications from flu," Bryant-Stephens says.

T.J.'s parents gave him what asthma experts call "maintenance medications" every day: an oral Zyrtec (cetirizine) for allergies and the inhaled corticosteroid Flovent (fluticasone), which reduces inflammation in the lungs. They knew he needed the H1N1 vaccine, says T.J.'s mom, but it hadn't become available in their area yet.

Unlike T.J., many asthmatic children do not take medications as prescribed, sometimes because of cost or parental concerns about side effects, Gelfand says.

"I'd say to any parent, this is not a time to relax compliance. The drugs we have for asthma are as a rule not effective if taken on an intermittent basis, except in possibly the mildest of cases," Gelfand says.

As for vaccines, the CDC recommends that children with breathing issues get the shot form of the vaccine – two doses spread out by a month in those under age 9 – instead of the nasal mist.

If a child does get flulike symptoms, there are steps caregivers should take, says Carolyn Kercsmar, director of the Asthma Center at Cincinnati Children's.

She says if a child develops a fever, is feeling poorly, has chest pain, a bad cough or extreme fatigue, see a doctor right away.

Rough night, quick comeback

T.J.'s parents took the correct steps, Kercsmar says. After additional home albuterol treatments didn't budge his symptoms, they scooted fast to the pediatrician, who sent him on to the ER. There, Jennifer Berndsen says, "they did three back-to-back albuterol treatments – continuous for about an hour. He was so sick by then, poor thing."

He then received a cornucopia of drugs: Motrin to help reduce fever, antibiotics for atypical pneumonia that a chest X-ray revealed, and an intravenous line of magnesium sulfate to help further open up his airways. They dosed him with the steroid prednisone to simmer down inflammation, and he received pure oxygen through a nose mask, Berndsen says.

After he was moved to a room well after midnight and an H1N1 swab came up positive, he was given Tamiflu (oseltamivir).

"These are the children who can benefit from starting Tamiflu right away. It can turn a very nasty disease into one that's tolerable," says Kercsmar, who adds that it works best started within 48 hours, but even within 72 hours can help.

Berndsen reports that though her son's night in the hospital was rough, the turnaround was fast.

"By noon the next day, Tuesday, Nov. 10, T.J. was feeling well enough to eat a chili dog and a pretzel with cheese," she says. He went home that night.


P.S. Boost your immune system by eating Vitamin C and Vitamin D rich foods and fruits.



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Users Complain About New Asthma Inhalers

A year ago the government ordered a big change in asthma inhalers.

The propellant used to force the medication out of the inhaler was changed to a more environmentally safe chemical.

The old albuterol inhalers used chlorofluorocarbon (CFC), but it’s believed the CFC damages the ozone.

As of the first of the year, CFC inhalers were banned and hydroflouroalkane (HFA) was used as a propellant instead.

While the HFA may be better for the environment, some patients and doctors say the inhalers may be dangerous for patients.

Katie Mitchell of Pittsburgh suffers from severe asthma.

She described what an asthma attack feels like. “My chest gets tight, feels like an elephant on my chest, then your airways constrict and you kind of gasp for air.”

Mitchell, a junior at Slippery Rock University, relies on an albuterol inhaler to control her symptoms. Like all asthma patients, her inhaler now contains the environmentally friendly propellant HFA.

She said the new inhaler put her in a life-and-death situation.

“I went to use it and nothing came out and I started panicking because I didn't know what to do. I was shaking it and I had to prime the inhaler six times before I could actually use it, which is dangerous for someone with asthma,” Mitchell said.

Mitchell isn’t the only asthma sufferer who has had problems with the new inhalers.

The FDA told Channel 11 it has gotten many similar complaints about the new inhalers.

Dr. David Skoner, an asthma and allergy specialist at Allegheny General Hospital, said he’s also had patients complain about the inhalers.

Skoner said, “These have a tendency to plug up the little holes where the drug comes out. That can cause a life hyphen threatening situation.”

The medication is stickier, so it can clog the hole it comes out of and can reduce the amount of medication delivered.

Many patients don’t realize they must now take the inhaler apart and clean it at least once a week, which they didn’t have to do with the old inhalers.

Mitchell now cleans her inhaler after every use to make sure it will work the next time she needs it.

“If you're having an asthma attack and you use your inhaler and it's clogged, you can't go over to the sink and wash it out,” Mitchell said.

Skoner said the drug manufacturers recommend taking the inhaler mouthpiece apart and running warm water through it for 30 seconds. Then flip it over and run warm water through the other end for another 30 seconds. Then shake it off and let it air dry overnight before putting it back together.

Clogging isn’t the only complaint the FDA is getting.

The old propellant pushed the medication out with a lot of force, but the new propellant sends the medication out in a gentle plume.

Because it feels and tastes different, many of Skoner’s patients don't think it's working.

“The taste and feel are very different. The CFC felt cold in the back of the throat. This one doesn’t. They knew what the old one felt like . When they use the new one, they don’t feel that, so they don’t feel they are getting the drug and may take more puffs of it,” Skoner said.

Skoner and the FDA said tests show the new propellant still delivers the right amount of medication.

Another drawback of the new inhalers is the cost. The new inhalers are two to three times the price of the old generic inhalers.


P.S. prevent asthma attacks by eating Vitamin C and Vitamin D rich foods and fruits.



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Asthma drug developer raises $17 million

Last week asthma drug developer Altair Therapeutics raised $17 million in a Series A funding round that was led by Domain Associates and capped a two-year startup financing period.

Other investors in the round include AgeChem Venture Fund, Thomas McNerney & Partners, Forward Ventures and Isis Pharmaceuticals.

San Diego-based Altair held its first close of $4 million in February, and it then raised the total to $11 million in August, according to Thomson Reuters. Previously, in late 2007, the company raised $6 million from Forward Ventures, Thomas McNerney & Partners, and an undisclosed investor, according to Thomson Reuters. CEO Joel Martin, formerly a partner at Forward Ventures, which helped seed the company, joined the startup in May.

Martin said the company is looking to open another fundraising round next year and added the current round will be used to fund phase II(a) trials for its asthma inhaler product, AIR645. Once it acquires the data from those trials, said Martin, it will go into phase II(b). Altair's goal is to prevent asthma attacks by targeting two different inflammatory pathways in the lungs.

Martin said the experimental data and the need in the market compelled him to join the company. About 16.4 million adults and 7 million children nationwide suffer from asthma, according to the Centers for Disease Control and Prevention.

Products that treat asthma produce about $7 billion annually in sales, Martin said. Most of the sales, or about $4 billion, come from small mid-sized drug companies instead of industry giants, he said.

P.S. prevent asthma attacks by eating Vitamin C and Vitamin D rich foods and fruits.

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Dr. Andy: Used correctly, inhaler effective

The metered dose inhaler, also known as the pump inhaler, has been the main treatment for lung problems such as asthma since it was first sold in the 1950s. For most it is a convenient and cost-effective way to get medications such as Albuterol into the lungs. Earlier this year a major change in these devices occurred, a change which several of my patients are convinced has made their inhalers less effective.

In the past, the propellant in inhalers was a chlorofluorocarbon (CFC) such as freon. However, as freon has disappeared from our air conditioners, so it did from pump inhalers. In fact CFCs have been banned internationally. Today, the inhaler propellant is a hydrofluoroalkanes (HFA).

In the older CFC inhalers, up to 80 percent of the aerosol one breathed in from the inhaler was the propellant. The CFC also caused the cold sensation that many patients associate with their old inhaler medications. The newer HFA inhalers don't have the same cold sensation, and also do not propel the medication at as high a speed. This results in more medicine actually being delivered into the lungs.

Discussions of pump inhalers would also not be complete without mentioning spacers, or holding chambers. These are usually plastic tubes with the inhaler plugged into one end, and the other end in the patient's mouth. Using a spacer dramatically increases the effectiveness of pump inhaler medications.

Using a spacer with a pump inhaler has been shown in repeat studies to help kids with asthma improve faster than when treated with an inhaler without a spacer attached. There is also no need to coordinate the inhalation with the pumping of the inhaler.

The spacer allows more medication to get to the lungs by allowing it to slow down in the chamber, and may reduce some common complications with inhaled steroids, such as oral thrush. For younger children, a mask can even be fitted to the mouth end of the chamber.

Be sure to clean your spacer chamber prior to using it with a mild dishwashing detergent, and repeat that cleaning process occasionally. This will reduce the electrostatic charge that can build up on the plastic, which attracts the medication particles, reducing the amount available for inhaling into the lungs.

In regard to nebulizer machines vs. the pump inhalers with a spacing chamber, numerous repeat studies have shown that a correctly used pump inhaler with a spacing chamber is as effective, if not more effective, than a nebulizer treatment. The significantly lower cost of inhaler medication, ease of portability and lack of reliance upon electrical equipment are just added benefits of inhalers over nebulizer machines.

So if you, or your child, use an inhaled medicine, be sure to talk with your doctor to verify you are using it correctly. Don't be afraid to ask questions, and remember - we work for you.


P.S. prevent asthma attacks by eating Vitamin C and Vitamin D rich foods and fruits.



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How to Use Your Albuterol in Asthma Treatment

Albuterol, also commonly called salbutamol, is one of the most common medications that you would be given if you have asthma. Albuterol is a bronchodilator, and as such its main purpose is to relax the muscles in your airways to allow more air to pass through. It is one of the most effective weapons against asthma attacks and is important to have with you at all times. Call your doctor or get one from the nearest pharmacy if you think that you are running out. Having two inhalers just in case one gets lost is also a good idea. If you feel that you medication is not working as is used to, or if you are reacting negatively to the medication, inform your doctor right away.

Knowing the proper procedures when taking your inhaler can prove crucial and even life-saving. Here’s the list of the things that you need to take note of when using your Albuterol inhaler:

Make sure the inhaler canister is properly inserted. If you encounter difficulties inserting the canister refer to the manufacturer leaflets or diagrams that can be found either on the packaging or inside the box of medicine.

Shake the inhaler for about ten seconds and actuate the device at least once to test. Shaking ensures effectiveness of the medication while test spraying can help get rid of any foreign object that may be in the nozzle.

When having an asthma attack, lying down makes you feel worse. So to avoid rendering your inhaler useless, use it while sitting in an upright position. Using the inhaler while sitting or standing increases the rate at which the medicine can reach your lungs.

Place in inhaler about an inch away from your mouth, if you are having difficulty estimating you can also use a spacer to help you out. Remember to forcefully inhale every time you puff. Inhaling forcefully will ensure that the medicine goes directly into your lungs and not end up at the back of your throat or just circulate inside your mouth.

After inhaling the medication, hold your breath for five to ten seconds. This allows the medication to travel further into the air passages. If you need additional puffs, wait about thirty seconds before doing so again.

Replace the cap after use. Rinse your mouth with water to clear any residue of the medicine.

Depending on your asthma severity and advice taken from your doctor, you may be required to take more puffs. It is important that you adhere strictly to the instructions given to you. Bronchodilators can have side effects. Not using them to be as efficient as they should leads you to use them for a longer term. Your albuterol treatment effectivity is directly proportional to how well you use it.

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