ROUGH TRANSITION TO A NEW ASTHMA INHALER
By Laurie Tarkan
Published: May 13, 2008
The New York Times
Millions of people with asthma and other lung diseases will have to switch inhalers by the end of the year. And for many, the transition will not be smooth.
The change — mandated by the federal government in 2005, to go into effect next Jan. 1 — is to comply with the 1987 treaty to protect the earth’s ozone layer. It bans most uses of chlorofluorocarbons, or CFCs, which are used as propellants in many inhalers.

CFC-free inhalers have been available for more than a decade. But four million to five million users have yet to switch, according to the consumer advocacy group Allergy and Asthma Network Mothers of Asthmatics.

For one thing, the old inhalers cost much less — an average of $13.50, or one-third the price of a CFC-free inhaler, which uses propellants called HFAs, for hydrofluoroalkanes. (CFC inhalers are generic; HFA inhalers are brand-name.) People with asthma use an average of three or four inhalers a year, but some patients use one a month.

Moreover, the new and old inhalers differ in feel, force and taste, and how they are primed and cleaned. Advocates for people with asthma say doctors and patients have not been educated about the changes.

“What the government failed to do is to mandate anyone to tell patients and physicians this transition was happening,” said Nancy Sander, president of the asthma group. “There is no education, no monitoring of patients, no financial assistance to patients who have to pay higher prices for the new drugs.”

As a result, she and others say, there have been unnecessary fears about the newer inhalers, preventable trips to the emergency room and even some hoarding of CFC inhalers.

Callers to a hot line run by Ms. Sander’s group have complained that when they were switched to the new inhalers, the differences between the two types were never explained. Many thought that their device was broken or that their symptoms were not being relieved by the new inhalers.

The Food and Drug Administration says that since January 2007 it has received 415 complaints about HFA inhalers’ costing too much or not working properly. After a public meeting last month in which doctors and patients said most people were unaware of the transition, the agency has been stepping up educational efforts, with several public service announcements expected by the end of this month, said Deborah Henderson, an official at the Center for Drug Evaluation and Research.

Both types of inhalers use albuterol, a short-acting medication that can prevent an asthma attack when used preventively — before exercising, for example — or at the first sign of breathing trouble.

But the cost difference has meant huge gains for drug companies. As people switched to HFA inhalers in 2006 and 2007, sales of all albuterol inhalers jumped from about $500 million to $1.1 billion, according to I.M.S. Health, a health care information company. Of the 40.5 million prescriptions written for albuterol inhalers last year, it said, about half were CFC and half were HFA inhalers.

And even though there are important differences between the four brands of HFA inhalers, some insurers cover only one of the four. Advocates say the higher cost may keep patients from buying inhalers or force them to cut back on other medications or switch to a less effective over-the-counter inhaler that uses epinephrine.

Several members of Congress are asking the Bush administration to require insurers, including the Medicare and Medicaid programs, to cover the new inhalers equally. Representative Steve Kagen, a Wisconsin Democrat who is also an allergy and asthma physician, said it was important “to make sure there’s as little co-pay as possible.”

The four HFA inhalers are Ventolin by GlaxoSmithKline, ProAir by Teva, Proventil by Schering-Plough and Xopenex by Sepracor. (Xopenex uses a different chemical, levalbuterol.) All companies have give-away programs for those in need and are providing free samples that doctors give to their patients. There is also financial assistance available through the Partnership for Prescription Assistance (1-888-477-2669).

Studies show that HFA inhalers are as effective as CFC inhalers and have the same rate of side effects. But if they are not used properly, patients will not get adequate doses. There are three critical differences.

HFA inhalers must be pumped four times to prime them — a number that was not so critical with the more forgiving CFC inhalers, said Dr. Leslie Hendeles, professor of pharmacy and pediatrics at the University of Florida. And each brand of the newer inhaler requires a different frequency of priming.

HFA inhalers have a weaker spray. “It’s very soft so people think it’s not working,” Dr. Stoloff said. Where CFC inhalers deliver a powerful force that feels as if the airway is being pushed open, the newer ones provide a warm, soft mist that also has a distinct taste.

They also require a slower inhale. “You have to take a nice slow, deep breath and hold it,” Ms. Sander said. If people worry that it’s not working, they may not take the second puff, may fail to wait the necessary 30 seconds between puffs or may take too many puffs. ,And their anxiety may rise, further constricting their airways.

HFA inhalers need to be washed with warm water and air dried once a week. The medication is stickier and will clog the hole, reducing the amount of medication the spray delivers.

There are also important differences among the brands, though some doctors simply write Albuterol HFA on the prescription, leaving the pharmacist to choose the brand. Only one, Ventalin, has a dose counter, which helps users keep track of how much medication is left. ProAir appears to be on many insurance companies’ lists of approved medications, but it has the softest spray, Dr. Stoloff said.

To read the full article, go to NY Times.com

Acknowledgement: thanks to Dr. Munitz for calling our attention to this article

I was recently embroiled in an online discussion with several pulmonary and primary care colleagues regarding the efficacy of Allergen Immunotherapy in the treatment of asthma and the future of sublingual immunotherapy, which I think is worth sharing. Let’s start off with some Frequently Asked Questions:
Whare are “Allergy Shots”?
Allergen immunotherapy or “allergy shots” is a form of treatment aimed at decreasing sensitivity to substances called allergens which were identified by allergy testing. Allergen immunotherapy involves injecting increasing amounts of these allergens to a patient over a period of time to decrease the patient’s sensitivity to the allergens, prevent development of new allergies, and in children, prevent progression from allergic rhinitis to asthma. Allergen immunotherapy can lead to long-lasting relief of allergy symptoms after treatment is discontinued.

How does Allergen Immunotherapy work?
Allergen immunotherapy works like a vaccine. Your body responds to injected amounts of a specific allergen by developing immunity or tolerance. There are two phases to immunotherapy: a build-up phase and a maintenance phase.

When will the allergy shots start working and when can I stop my meds?
The benefits of allergen immunotherapy, in terms of reduced allergy symptoms, can begin during the build-up phase but may take as long as 12 months on the maintenance doses. It is important to continue taking allergy medications as prescribed together with the allergy shots during the build-up phase. Later, when your symptoms improve, you may discuss with your doctor whether you can discontinue some of your allergy medications.
If you do not get your allergy shots on schedule, it will take longer to reach the maintenance dose and longer for the allergy shots to work effectively.

How long do I have to take the Allergy shots?
With currently available allergen extracts, maintenance treatment is generally continued for 3 to 5 years after the build-up phase, which can take up to 6 to 9 months. The majority of inidividuals experience lasting remission but a minority may relapse after discontinuing immunotherapy, therefore the decision to stop must be individualized.

How effective is allergen immunotherapy?
Immunotherapy is successful in up to 90-95% of patients with seasonal allergies and up to 85% of patients with year-round allergies.

Asthma is a multifactorial disease. Allergic rhinitis/ sinusitis has definitively been shown to contribute to the severity of asthma in patients. One of the modalities used to treat allergic rhinitis/ sinusitis and asthma is allergen immunotherapy (IT). By no means is anyone suggesting that allergen immunotherapy be used INSTEAD OF inhaled steroids, however allergen IT does have solid data to show its efficacy when used in conjunction with other modalities.

This is topic has been addressed by the American College of Allergy, Asthma, and Immunology in its position paper on the Cost Effectiveness of Immunotherapy for Asthma.

Regarding sublingual immunotherapy, there is considerable evidence that sublingual immunotherapy for allergic rhino-conjunctivitis has been effective using high doses of grass extract. This is commercially available and used in Europe, but has yet to have FDA approval in the USA. Some studies showing efficacy are cited below:
1. Calderon M, Essendrop M. Specific immunotherapy with high dose SO standardized grass allergen tablets was safe and well tolerated. J Investig Allergol Clin Immunol. 2006;16(6):338-44. 2. Nelson HS. Advances in upper airway diseases and allergen immunotherapy. J Allergy Clin Immunol. 2007 Feb 8; [Epub ahead of print]
That being said, appropriate dosing and efficacy with multiple SL allergen combinations are still an issue.

The “sublingual immunotherapy” that is pure quackery has been used to treat “idiopathic environmental intolerance” (IEI) by means of “neutralizing” extracts administered as sublingual drops usually at such a miniscule dose that it is really only placebo. See the AAAAI position statement on this.

For a tragic example of the use of these “neutralizing sublingual drops” for treatment of IEI or “multiple chemical sensitivity syndrome” see the “Tragic Example” post on this blog.

Link: Allergen Immunotherapy Practice Parameters
AAAI Tips to Remember: What are Allergy Shots?
Table: Clinical Indications for Allergen Immunotherapy

Pollen Grains

From the AAAI Rhinitis Tips:
Do you have bouts of sneezing and itching, or a runny or stuffy nose that do not seem to go away? If so, you may have rhinitis.

Rhinitis is one of the most common illnesses in the United States , affecting more than 50 million people. It often coexists with other respiratory disorders, such as asthma. Rhinitis has a significant impact on the quality of life of those who suffer from it. In addition, it can contribute to other conditions such as sinus problems, ear problems, sleep problems, and learning problems. In patients with asthma, uncontrolled rhinitis seems to make asthma worse.

Allergic rhinitis
Allergic rhinitis is caused by substances that we breathe called allergens. Allergens are usually harmless substances that can cause problems only in some people. These problems are caused because the immune system of people with allergic rhinitis mistakenly identifies these substances as intruders and generates a reaction against them. During this reaction, the immune system cells release substances such as histamine and leukotrienes that cause the symptoms of allergic rhinitis; these and other substances also cause inflammation in the nasal lining that makes the nose very sensitive to irritants such as smoke and strong odors or to changes in the temperature and humidity of the air.

Causes:

1. When allergic rhinitis is caused by common outdoor allergens, such as airborne tree, grass and weed pollens or mold, it is called seasonal allergic rhinitis, or “hay fever.”
2. Allergic rhinitis is also triggered by common indoor allergens, such as animal dander (dried skin flakes and saliva), indoor mold, droppings from dust mites and cockroach particles. This is called perennial allergic rhinitis.

Symptoms

Sneezing
Stuffy nose (congestion)
Runny nose
Itching in the nose, roof of the mouth, throat, eyes and ears
Diagnosis
If you have symptoms of allergic rhinitis, an allergist/immunologist can help determine which specific allergens are triggering your illness. He or she will take a thorough health history, and then test use to determine if you have allergies. Skin tests or blood tests are the most common methods for determining your allergic rhinitis triggers.

What to Do During Pollen Season:
When outdoor pollens are high, remain indoors, particularly in the late morning. Pollen grains can cause significant allergic symptoms like asthma and allergic rhinitis, particularly during the spring and the fall. It is difficult to avoid pollen because it is windborne and can cover wide distances. Short of moving to a different location, here are some tips for avoiding pollen during the season.

1. The pollen count is usually highest in the late morning and early afternoon particularly during sunny, windy days. The pollen count measures the concentration of a specific pollen like birch tree pollen, in the area in a specific area and time. A pollen count is a useful guide for when it is advisable to stay indoors and avoid contact with pollen.
2. Keep the windows and doors closed during the allergy season.
3. Install a room air conditioner with a special filter.The special filter (High Efficiency Particulate Air or HEPA filter) traps airborne allergens. If the house does not have central air, the best spot to put the air conditioner and filter would be the bedroom. Change the filters frequently. An allergic person should also use the car air conditioner to decrease pollen exposure when commuting. Pollen allergic persons should not have a window fan blowing into their bedroom as this will maintain outdoor pollen exposure all night.
4. Avoid working outdoors, if you must wear a special face mask. The face mask is designed to filter pollen out of the air and keep it from reaching the nasal passages.
5. Consider taking a vacation at the height of the pollen season. Preferably at a location where the pollen exposure is minimal, like the seashore.

Links: Allergy Medications
Info on Allergy Shots

From the American Academy of Allergy, Asthma, and Immunology:  

Topic of the Month: December 2006: Sinusitis FAQs

AAAAI Sinusitis Video

Pediatric Sinusitis Video

What is sinusitis?
Sinusitis is an inflammation of one or more of the paranasal sinuses, the hollow cavities within the cheek bones found around the eyes and behind the nose. The primary functions of these sinuses are to warm, moisten and filter the air in the nasal cavity. They also play a role in our ability to vocalize certain sounds.

Sinusitis can affect the nose, eyes, or middle ear. Symptoms of sinusitis include some or all of the following:

• Thick yellow-green nasal discharge
• Bad-tasting post-nasal drip
• Cough
• Head congestion and an accompanying headache
• Nasal congestion
• Feeling of facial swelling and pressure
• Toothache
• Constant tiredness

Are there different kinds of sinusitis?
Sinusitis can be divided into acute, chronic and recurrent. The classifications are based on length of symptoms, or the specific sinus involved, or both. The classification is as follows:

• Acute sinusitis: symptoms for less than 4 weeks consisting of some or all of the following: persistent symptoms of an upper respiratory tract infection, purulent rhinorrhea, postnasal drainage, anosmia, nasal congestion, facial pain, headache, fever, cough, and purulent discharge.
• Chronic sinusitis: symptoms for 12 weeks or longer of varying severity consisting of the same symptoms as seen in acute sinusitis. In chronic sinusitis there should be abnormal findings on CT or MRI. Some patients with chronic sinusitis might present with vague or insidious symptoms.
• Recurrent sinusitis: three or more episodes of acute sinusitis per year. Patients with recurrent sinusitis might be infected by different organisms at different times.

Who gets sinusitis?
Sinusitis is one of the most diagnosed diseases in the United States. It affects approximately 16% of the adult population and is responsible for nearly $5.8 billion in health care costs annually.

Although colds are the most common cause of acute sinusitis, it is more likely that people with other allergic diseases such as allergies or asthma, will develop sinusitis. Allergies can trigger inflammation of the sinuses and nasal mucous linings. This inflammation prevents the sinus cavities from clearing out bacteria, and increases your chances of developing sinusitis. The incidence of sinusitis in asthma patients ranges from 40%-75% as well.

If you test positive for allergic disease, your allergist/immunologist can suggest the appropriate treatments to control your symptoms, and thus reducing the risk of developing an infection. People with sinus problems should avoid environmental irritants such as tobacco smoke and strong chemical odors, which may increase symptoms.

Another cause of sinusitis is structural problems in the nose - such as narrow drainage passages, tumors or polyps, or a deviated nasal septum (the bone and cartilage between the left and right sides of the nose) - may be another cause of sinusitis. Surgery is sometimes needed to correct these problems, but only after all other medical treatments have failed.

Who diagnoses sinusitis?
Allergist/immunologists diagnose sinusitis based on a combination of clinical history, physical examination, imaging studies, and/or laboratory tests. An allergist/immunologist will be able to help you manage your sinusitis, and will determine if an allergic disease is contributing to your condition. He/she will also determine what triggers your symptoms, as well as other triggers that may be causing sinus obstruction, and recommendations on how to treat that infection. An allergist/immunologist can also determine if a visit with an ENT/Otolaryngologist is needed for consideration of surgery for the sinusitis.

Allergist/immunologists are specialists trained in evaluating for all possible conditions related to sinusitis. These physicians use a management strategy to not only treat current infections, but to also provide management that lowers the risk for future sinus infections. Allergist/immunologists can also help to determine when surgery is indicated as part of the overall management. If you have questions about any of these treatments, be sure to ask your allergist/immunologist for more information.

The AAAAI’s How the Allergist/Immunologist Can Help: Consultation and Referral Guidelines Citing the Evidence provide information to assist patients and health care professionals in determining when a patient may need consultation or ongoing specialty care by the allergist/immunologist. Patients should see an allergist/immunologist if they:

• Have chronic or recurrent infectious rhinosinusitis.
• Have other types of chronic rhinosinusitis
• Have allergic fungal rhinosinusitis.

What are treatments for sinusitis?
Sinusitis generally requires a combination of therapies. Allergist/immunologists should withhold from prescribing antibiotics for 10-14 days, unless severe symptoms develop such as fever, facial pain or tenderness, or swelling around the eye. An allergist/immunologist may also prescribe a medication to reduce blockage or to control allergies to help keep the sinus passages open. This medicine may be a decongestant, a mucus-thinning medicine or a cortisone nasal spray. Antihistamines, cromolyn and topical steroid nasal sprays help control allergic inflammation. Other treatments that can be helpful to control and reduce symptoms of sinusitis include, breathing in hot, moist air, applying hot packs, and washing the nasal cavities with salt water.

How can sinusitis be prevented?
If you have predisposing conditions that lead to excess mucus and inflammation of the nose, such as allergic disease, structural problems or are in a profession that leads to greater risk for developing these conditions, you are more likely to develop sinusitis and should contact an allergist/immunologist for prevention methods.

Any of kind of predisposing factors makes it important to have a long-term management plan to help control allergic diseases and to keep the nasal inflammation well controlled with medications between sinusitis episodes, and consideration of surgical repair of structural abnormalities, if present and all other medical treatments have failed.

Additional Resources:

• Allergy Asthma Source: Sinusitis

Allergen: A substance, usually a protein such as pollen, animal dander, food, or medication, which can trigger an allergic reaction

Allergic rhinitis: refers to the sneezing, itching, and mucus production associated with an reaction to allergens in the air such as pollen, dust mites, animals, or molds. May be seasonal or year-round.

Allergies: Exaggerated reaction of the immune system when exposed to certain substances, usually related to the presence of the allergic antibody, IgE

Allergist: Physician who specializes in the diagnosis and treatment of allergy related problems including allergic rhinitis, asthma, drug and food allergy

Anaphylaxis: Severe, life-threatening allergic reaction which may result in death, requires immediate emergency medical treatment

Angioedema: refers to swelling in the deeper layers of the skin, usually associated with urticaria/ hives

Antibody: A protein in the immune system that reacts to mostly foreign substances in the body

Atopic Dermatitis: A recurring itchy skin rash also called “eczema” that often appears in the first few years of life but can persist in allergic people

Challenge test: A test used to confirm whether a person is allergic to a particular substance, performed under close supervision by a physician.

Epinephrine: also called adrenaline, injectable medication used to treat anaphylaxis by constricting blood vessels

Histamine: Chemical released by immune cells during an allergic reaction, causes swelling and inflammation

Hives: See Urticaria

Immunoglobulin E: Type of antibody involved in most allergic reactions

Immunotherapy: Series of injections that help build up the body’s tolerance to an allergen

RadioAllergosorbent Test (RAST): A blood test that measures the amount of IgE antibody in the blood to a specific allergen

Rhinitis: Swelling, congestion, and increased mucus in the nasal passages, may be due to allergies

Sinusitis: Swelling or infection in one or more of the sinuses, which are air spaces in the skull around the nose and eyes

Urticaria: also known as hives, Itchy wheals on the skin

AAAAI video 

Diagnosis or determining whether someone is suffering from allergies or not, begins with the history. The physician or health care provider is interested in knowing the pattern of the symptoms and their relation to any possible allergen exposures. For example in the case of allergic rhinitis one would ask:

• Do you sneeze or get itchy nose/ eyes during a specific season or all year round?
• Is it worse at night or during the day?
• Indoors or outdoors?
• With exposure to pets or other animals?

Tests are performed when the history points to a possible allergic reaction to a specific allergen. Skin tests and RadioAllergoSorbent blood Tests (RAST) are performed to determine the presence or measure the level of the allergic antibody, IgE, to the allergen.

It should be stressed that a positive allergy test alone does not make the diagnosis of an allergic reaction. The results of the test must be correlated with the patient’s history.

1. Skin tests the most commonly used form of allergy testing. In this test, an extract of the allergen is placed on the skin, then a superficial puncture or scratch is made at the site allowing contact between the deeper layer of the skin and the allergen.If a person is allergic to that particular allergen, an itchy wheal with surrounding redness will form within 15 minutes. If this “scratch” or epicutaneous test is negative, in the case of airborne or medication allergies, the patient may then go on to get small doses of the allergen injected under the skin, called “intradermal” skin testing. The intradermal test is not recommended for food allergens.
2. Blood Test or RAST- measures the levels of the allergic antibody IgE in the blood to specific allergens. This test is not as sensitive as the skin test, but is used if a skin test can not be performed because the patient is taking antihistamines, has a rash covering his body, or if he or she had a severe allergic reaction (anaphylaxis) to the suspected allergen.
3. Challenge Test- In the case of food or medications, even if a person has a negative skin test or blood test, there is still a chance that a person may still have an allergic reaction to the suspected allergen.In this case, challenge tests are performed where the person is given small, increasing doses of the suspected food or medication at regular intervals and under close monitoring to determine if he or she develops any signs or symptoms of an allergic reaction. These tests may be open or blinded where the person and/or the physician may or may not know whether the patient is getting the actual allergen or a placebo to avoid bias.

Allergy Cartoon video (Osaka Japanese cartoon):

AAAAI What is an Allergic Reaction video

AAAAI Rhinitis Video

Allergy refers to the exaggerated reaction of the immune system in susceptible people, when it is exposed to a protein called an allergen. An allergen can take the form of tree pollen, peanut, cat dander, stinging insect venom, penicillin, and latex, among many others. Exposure to the allergen causes immune cells to release substances such as histamine in parts of the body which lead to itching, swelling, sneezing, hives, wheezing, low blood pressure, and sometimes, even death.

Allergens do not cause symptoms in all people, only in a group of people who develop Immunoglobulin E (IgE) to the particular allergen. IgE is the molecule responsible for triggering the allergic response in most people and its detection in the blood or the skin is an important part of the process when we determine whether or not someone has allergies.

An allergic reaction results in the release of the chemical histamine into the blood and different parts of the body. Histamine causes increased production of mucus, itching, swelling, muscle spasms, and leakage and dilation of blood vessels. Where the histamine is released determines the symptoms of the allergic reaction as follows:

Eyes: watery eyes, itching, red eyes

Nose: Sneezing, itchy nose, runny nose, congestion

Lungs: Cough, wheezing, difficulty breathing (due to airway muscle spasms)

Gastro-Intestinal: Nausea, vomiting, diarrhea, abdominal spasms

Skin: Itching, hives, swelling

Circulatory System: Dizziness, Low blood pressure, palpitations, passing out