What Is Breathe-ease® XL ?

Breathe-ease® XL is a new moisturizing and irrigation solution for the nose that is both effective and economical. Formulated to approximate the body's natural salinity and electrolyte composition, this unique formulation is reported in medical journals best for nasal cilia to prevent the nasal cilia from slowing due to infection, allergy, and contagion and more appropriate than regular saline.  Breathe-ease® XL solution incorporates a formula proven effective in clinical trials, is additive-free, and is highly economical. Convenient and easy to use you make Breathe-ease
® XL solution yourself by just mixing our formula. May be used as both a isotonic or hypertonic solution.

Each package contains:  
190gm of Breathe-ease®
XL powder for nasal solution  
Refillable spray bottle  
1/4 teaspoon measuring spoon - white - for adding to 4 ounces of water for spray  
1 teaspoon measuring spoon - blue to add to a pint of water for irrigation with the Hydro Pulse
® Nasal/Sinus Irrigation System or Water Pik™ type appliance.



What is Breathe-ease® XL used for?
Saline nose drops are needed for most nasal and sinus conditions. They are recommended for dryness, crusting, and as an aid to normal nasal function. Saline sprays can also be used to prevent and treat nose bleeds.

The nose is supposed to moisten inhaled air, helping to maintain a moist environment for the cilia in the sinuses. These cilia are the body's first line of defense against infection. The moist, mucous environment also forms a pathway for the good white cells to reach the bad bacteria that may attempt to infect the body through inhalation.

Any dryness, itching, or crusting in the nose means that a moisturizer is needed for the nose to do it's job. Saline  had always been considered  the most common, safe, and simple such moisturizer. Today we know that the preservatives that must be added to insure a long long shelf life can be harmful or irritating to the nose, especially when the nose is irritated already .  Here is a partial list of the additives found in saline nasal sprays:

 

Nasal Spray Additives:

Benzalkonium

Benzyl Alcohol

Thimerosal (Merthiolate)

Edetate Disodium

MonoBasic Sodium Phosphate

Providone

DiBasic Sodium Phosphate

Disodium ETA

Potassium Phosphate Monobasic

Iodine

Phenylcarbinol

Sodium Silicoaluminate


It is important to avoid any of these preservatives that might irritate an already sore nose. So Breathe-ease® XL was developed as a means of providing a solution for the dry irritated nose. 

However, the purpose of a saline type spray is to restore normal cilia function.  Professor Wilbert M Boek of University Hospital, Utrecht reported that solutions containing potassium chloride, calcium chloride, sodium bicarbonate, and salt were much better for restoring nasal/sinus cilia than those without these ingredients. Breathe-ease®XL is a formula designed to restore cilia function and avoid the use of some of the preservatives that can harm the delicate nasal membranes.   

Breathe-ease® XL is especially designed for use by the child.  The incidence of children with sinusitis is increasing at an alarming rate. Many of these children could be helped by regular use of moisturizer solution. Breathe-ease® XL is for kids: 

No preservative to burn 
Spray bottle that kids can handle easily 
Oval surface to place the kid's favorite sticker on. 

For use with the Hydro Pulse® Nasal / Sinus Irrigation System or Water Pik™  Style Irrigator 
Experience has shown that when the Breathe-ease®
XL formula is used for sinus irrigation, patients get better clearing of sinus infection and post nasal drip. This is because there is no iodine, preservatives, or silica in the formula. The measuring spoon allows for accurate measure. Add one teaspoon of Breathe-ease® XL to a pint of water in the Hydro Pulse™ Nasal / Sinus Irrigation System or Water Pik™ basin. Stir, then use as directed to restore cilia and remove purulent material. 

For Moisturizing Spray 
Using the white 1/4 teaspoon measuring spoon, add 1/4 ounce Breathe-ease®
XL formula powder to four ounces of  water. Spray nose as needed. Change once a week. The spray bottle can be used as a spray, to irrigate directly, or just as drops. 

For kids or adults with colored discharge: 3 to 4x a day. 
For kids or adults with nose bleed 3 to 4 x a day 
For dry weather twice a day 
For smog days twice or 3x a day 
To prevent nose bleeds twice a day
 

Use of spray bottle to irrigate: 

During the pollen season can use the spray bottle as an irrigator to remove pollen from the nose. Try this 3x a day after downtown smog or diesel exposure, irrigate to remove the particular matter. 

Costs
Spending four dollars or more plus tax for a penny's worth of saline solution must discourage a lot of people. With Breathe-ease®
XL  you get 150 or more refills of solution, refilling once a week.  You simply use the 1/4 teaspoon and add to four ounces of water. You can even save the surplus for further use.  So its economic to use for irrigation with the spray bottle as well. 

Calibrated Measurement 
Many worry about mixing the right amounts of saline. One teaspoon can vary enormously, as much as 40 % in one study. Here the teaspoon is exactly measured so there is no mistake. 
For use with the Hydro Pulse® Nasal / Sinus Irrigation System or Water Pik™  irrigator you get over 60 day's supply. With this special formula, and because  there are no preservatives, silica, or iodine, many patients require less days of irrigation. 

Isotonic or Hypertonic Saline - Which is best for you?
Doctors recommend both - but which is right for you?  Breathe-ease® XL unique formulation allows the user to adjust between the two methods as needed for greater individual comfort and control. For detailed information on which is right for you Click here.

Warm Saline   
Every doctor tells you to irrigate with warm saline. Warm solution helps bring more circulation to the area, and besides, it feels good. Yet, some solutions with additives can only be used at room temperature. 

Fresh 
For many customers once they have opened the store bought saline solution and carried it about for weeks, they no longer consider it to be fresh and toss it to buy a fresh bottle. Part of this has to do with the preservatives giving a "smell" kind of sensation. With Breathe-ease®
XL you know its fresh because you make it every week. 

Benzalkonium
The preservative Benzalkonium Sodium causes problems with nasal sprays. Around 1985, it was noted that the number and severity of cases of rhinitis medicamentosum was increasing with increased use of benzalkonium, an antibacterial preservative found in most over-the-counter prepared saline nasal spray products. Rhinitis medicamentosum means that the nose gets stuffy and congested after use of nose drops such as oxymetazoline (Afrin®). The more the nose drops are used, the more "rebound" when the drug wears off, that is, the worse the patient gets after the drops wear off, requiring more and more use of the drops. The drops become effectively addictive, and worse, the nose is always stuffy anytime the drug is not active in the nose.  Next, it was discovered that you could get rhinitis medicamentosum just form the Benzalkonium alone, as well as saline with Benzalkonium. So, it wasn't the nasal medication oxymetazoline that was responsible, but the Benzalkonium. The oxymetazoline did shrink the nose nicely, but the benzalkonim caused a rebound congestion. 

These additive problems are so important that the Dannemiller Memorial Educational Foundation gives special training to doctors on this subject. This training emphasizes that if you are allergic or have an infection, the additives can be more irritating than when you are "normal". 

Recent articles on the negative effects of Benzalkonium include:

Berg: Mucosa exposed to benzalkonium chloride showed squamus cell metaplasia ( the normal cells changed to undesirable cells). Benzalkonium chloride appears to be potentially toxic to the mucosa.

Steinsvag: benzalkonium chloride has toxic effects on human respiratory mucosa and human neutrophils. It destroyed mucosa and inhibited human neutrophil action.Benzalkonium chloride induces mucosal swelling, which explains why the presence of this preservative in a decongestant spray aggravates rhinitis medicamentosa.


References:

Physiologic and hypertonic saline solutions impair ciliary activity in vitro. Boek WM. Laryngoscope, 109(3):396-9 1999 Mar
Physiological salt solution (0.9%) was found to slow cilia movement. Locke-Ringers solution with soda bicarbonate, potassium and calcium chloride, and salt was found best for cilia. "This solution is more appropriate than saline for nasal irrigator and nebulazation or sinus lavage." He reported complete ciliastasis with some hypertonic solutions, often within 5 minutes of exposure.

Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy.1995; 25:957-965
Benzalkonium chloride induces mucosal swelling, which explains why the presence of this preservative in a decongestant spray aggravates nasal/sinus symptoms

Effects of topical nasal steroids on human respiratory mucosa and human granulocytes in vitro. Steinsv”ag S. Acta Otolaryngol (Stockh), 116(6):868-75 1996
"It is concluded that benzalkonium chloride has toxic effects on human respiratory mucosa and human neutrophils in vitro."

Effect of topical corticosteroids and topical antihistaminics on ciliary epithelium of human nasal mucosa in vitro. Hofmann T. HNO, 46(2):146-51 1998 Feb
"An irreversible cessation of ciliary movement was observed in all cells exposed to nasal sprays containing benzalconium chloride....." "we recommend that this preservative should not be used anymore in topical nasal medications."

The effects of topical nasal steroids on rat respiratory mucosa in vivo, with special reference to benzalkonium chloride. Berg OH. Allergy, 52(6):627-32 1997 Jun
"In conclusion, benzalkonium chloride appears to be potentially toxic to the nasal mucosa."

A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis. Adam P. Arch Fam Med, 7(1):39-43 1998 Jan-Feb
Hypertonic saline does not improve nasal symptoms or illness duration in patients with the common cold or rhinosinusitis. Thirty two percent of users noted burning and wouldn't use the product again.


 

ISOTONIC or HYPERTONIC SALINE

Currently there are several products on the market that use hypertonic saline to spray in the nose. What is hypertonic? In the body, there are chambers of fluid, mostly salt containing. When you are dehydrated in the hospital, they used to give you isotonic solution. Iso means equal. This refers to the fact that it is perfectly balanced, and exactly right for your body. The way the body works, there is a barrier like a cellophane between fluid systems. If both sides have the same concentration of salt, then no fluid is passed through this membrane, called a semi permeable membrane. When you want to put liquid into one area, you increase the amount of salt. This then becomes hypertonic - hyper meaning excess or increased. The fluid will flow through the membrane until both sides are equal in salt concentration. The fluid goes to the higher salt level. 

Hypertonic means less salt. If one side is hypertonic, the fluid will go from that side to the hypertonic side. This is the reason why persons with heart conditions limit their salt intake. Less salt means the body holds less fluids. If a heart patient takes hypertonic, his fluid in the body will increase resulting in swollen legs. Thus if a person drowns in a fresh water pond, the water will be sucked into his lungs because the osmotic pressure is higher in the lungs. If he drowns in an ocean, which is hypertonic, the water will be sucked out of his lungs. There has been some literature claiming that hypertonic saline is of value when the membranes of the nose are extremely swollen. That is the principle behind the hypertonic products. Exactly what effect these hypertonic solutions have on nasal function is still being investigated.

If you wish to try a hypertonic nasal solution, there are distinct advantages to using our Breathe-ease®XL solution. You start with a product, a modified Ringer's solution, which all hospitals now use for intravenous solution instead of saline. Numerous articles show that this solution is best for restoring nasal function.  Breathe-ease®XL is free of preservatives, especially Benzalkonium, known to impair cilia function. When used in the nasal spray it may give a burning sensation. Best of all, Breathe-ease®XL made hypertonic is much less expensive than the leading hypertonic solutions. When you make Breathe-ease®XL for spray, from a standard 190 gm bottle you can make 20 pints or 9,460 ounces of a 2x hypertonic solution. Or you can make it 3x hypertonic and make 14 pints or 3,890 ounces. Compare this to the size of the other leading hypertonic solutions. A 190gm bottle of Breathe-ease®XL will make up to 320 oz. of hypertonic saline equivalent to 40 single use bottles of the 8oz hypertonic solutions marketed by other manufacturers. Using Breathe.ease®XL in this manner allows our customers to adjust the concentration of the solution to meet their individual needs and comfort level - instead of a one size fits all mixture that may not be right for you. The purpose of any spray or irrigation is to get the nose healthy. If regular isotonic Breathe.ease®XL works - 1/4 teaspoon to four ounces, fine. You can use one ounce at a time and store the 3 ounces in the refrigerator and change it once a week - there is no preservative.  

  • If you want to try 2x hypertonic, just add the 1/4 teaspoon to 2 ounces of water or two 1/4 teaspoons to four ounces. Again, you can store the remainder in the refrigerator and change once a week.  Breathe.ease® XL comes with its own accurate 1/4 teaspoon measuring spoon. 

  • If you decide to go 3x hypertonic, just add 3 1/4 teaspoons to four ounces of water. One ounce goes into the spray bottle and 3 into the refrigerator, so, changing once a week, this lasts a month. So even using 3x the isotonic dose you should have enough to last 20+ months! Compare that to the price of ENTsol and Saltaire!

Again you may decide that the isotonic strength is best for you, so you don't need to buy anything else, just mix a fresh batch. Or you may decide on 2x hypertonic. Whichever you use this week, you can change it next week. Most important, you don't need to worry about preservatives. The ability to change concentration without the need to buy a new product is very important. For example if your nose is dry, the hypertonic can make the nose drier by taking liquid out. Here isotonic is much better, especially the Breathe.ease®XL formula. If the nose is very swollen, you may find the hypertonic works best for you. But you can always start with isotonic and move slowly into hypertonic. Some persons find that hypertonic too strong and must cut back. There is no one size that fits everyone all the time.

Each Breathe-ease®XL package contains:  
190gm of Breathe-easeXL
® powder for nasal solution  
Refillable spray bottle  
1/4 teaspoon measuring spoon - white - for adding to 4 ounces of water for spray  
1 teaspoon measuring spoon - blue to add to a pint of water for irrigation with the Hydro Pulse Nasal / Sinus Irrigation System
® or Water Pik type appliance.


References:

Physiologic and hypertonic saline solutions impair ciliary activity in vitro. Boek WM. Laryngoscope, 109(3):396-9 1999 Mar
Physiological salt solution (0.9%) was found to slow cilia movement. Locke-Ringers solution with soda bicarbonate, potassium and calcium chloride, and salt was found best for cilia. "This solution is more appropriate than saline for nasal irrigator and nebulazation or sinus lavage." He reported complete ciliastasis with some hypertonic solutions, often within 5 minutes of exposure.

Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy.1995; 25:957-965
Benzalkonium chloride induces mucosal swelling, which explains why the presence of this preservative in a decongestant spray aggravates nasal/sinus symptoms

Effects of topical nasal steroids on human respiratory mucosa and human granulocytes in vitro. Steinsv”ag S. Acta Otolaryngol (Stockh), 116(6):868-75 1996
"It is concluded that benzalkonium chloride has toxic effects on human respiratory mucosa and human neutrophils in vitro."

Effect of topical corticosteroids and topical antihistaminics on ciliary epithelium of human nasal mucosa in vitro. Hofmann T. HNO, 46(2):146-51 1998 Feb
"An irreversible cessation of ciliary movement was observed in all cells exposed to nasal sprays containing benzalconium chloride....." "we recommend that this preservative should not be used anymore in topical nasal medications."

The effects of topical nasal steroids on rat respiratory mucosa in vivo, with special reference to benzalkonium chloride. Berg OH. Allergy, 52(6):627-32 1997 Jun
"In conclusion, benzalkonium chloride appears to be potentially toxic to the nasal mucosa."

A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis. Adam P. Arch Fam Med, 7(1):39-43 1998 Jan-Feb
Hypertonic saline does not improve nasal symptoms or illness duration in patients with the common cold or rhinosinusitis. Thirty two percent of users noted burning and wouldn't use the product again.

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