Respimat to replace Handihaler

[LindaNY]

This should be a huge breakthrough. It uses a very fine mist that results in far superior lung deposition.

read all about it here

www.respimat.com/com/Main/benefits/index.jsp


www.pharmaceutical-business-review.com/article_feature.asp?guid=8D283B6C-91C1-4701-9EC7-50D778D79360

[larrynz]

I was on a trial for that about 3-4 years ago.
The plus is a finer mist.
The minus, like many other meds your timing must be good. I suspect more expensive

[Blossom/Jackie W.]

I'll have to read up on it in the a.m.

[LindaNY]

Larry when you were in the trial, did the new mist inhaler help more? The information on those sites says it gets down further.

oh and I"m sure it will be more expensive. Aren't all new meds?

[larrynz]

Linda when I started the trial I had to stop Symbicort, I went down badly, had to pull out and go back to my Symbicort.

[Blossom/Jackie W.]

I gather from quickly reading that it's aimed for use of Spiriva. I'm curious why they'd have had you come off Symbicort Larry since many people use both meds; they're not in competition with each other.

I can also see how the fine mist might be better and wouldn't require the strong inhalation (so they're saying) I've often wondered how folks who don't have enough "force" to inhale deep manage with the current inhalers...

[larrynz]

I think they wanted me off Symbicort to measure the improvement that could be had, the Symbicort would confuse things by making some of that improvement.
Today I had a phone call from the hospital, would I be available for a trial, the snag I had to stop Symbicort, I refused. It was for a mixture, spiriva and oxis.

[LindaNY]

larrynz said:

Linda when I started the trial I had to stop Symbicort, I went down badly, had to pull out and go back to my Symbicort.

I don't blame you one bit for pulling out.

If we try these things and get worse, then it's in our best interest to go back to what works.

[the bear]

I just had a prescription refilled for 3 months supply of Spiriva and it came with the old handihaler. Does anyone know when the new mister is due to come out??? bear.

[larrynz]

The little I know Bear

www.juraforum.de:80/jura/news/news/p/1/id/175900/f/109/

Boehringer Ingelheim and Pfizer today announced successfulcompletion of the approval process for authorisation to marketSPIRIVA(R) Respimat(R) in the European Union for people with chronicobstructive pulmonary disease (COPD). This positive opinion for theSPIRIVA(R) Respimat(R) is the cornerstone of all national approvalsin 25 countries of the European Union. SPIRIVA(R) Respimat(R) is apropellant-free, new generation inhaler that combines innovativetechnology with the proven efficacy of SPIRIVA(R) (tiotropium).(1)

"SPIRIVA(R) Respimat(R) represents a major step forward in COPDand inhalation therapy. Many patients find certain inhaler devicesdifficult to coordinate and use," said Professor Marc Decramer,Respiratory Division, University Hospitals, Katholieke UniversiteitLeuven, Belgium. "SPIRIVA(R) Respimat(R) has a unique andsophisticated delivery system, and a user friendly design, making iteasy to use and suitable for a broad range of patients with COPD. Inaddition the long-lasting, soft mist cloud generated by SPIRIVA(R)Respimat(R) ensures optimised delivery of SPIRIVA(R) to the lungs,helping patients breathe more easily," he added.

In clinical studies comparing inhaler devices,(1) patientspreferred Respimat(R) Soft Mist(TM) Inhaler, which may help increasepatient compliance with therapy.(2),(3),(4),(5) The noveldose-delivery system of the SPIRIVA(R) Respimat(R) also means thatunlike dry powder inhalers, the dose delivered is not dependent onpatients' inspiratory flow.

SPIRIVA(R) (tiotropium), a first-line maintenance therapy forCOPD, positively impacts the clinical course of the disease, helpingto change the way patients live with their condition.(6),(7) Theefficacy of SPIRIVA(R) has been demonstrated by an extensive clinicaldevelopment programme, which has treated over 25,000 patients.(1) Itis the most prescribed brand in COPD in the world.(8)

The SPIRIVA(R) Respimat(R) delivery system relies on energyreleased from a spring, rather than propellants, to produce along-lasting, slow moving Soft Mist(TM). The innovative design makesSPIRIVA(R) Respimat(R) easy to use, and the Soft Mist(TM) results inimproved delivery of SPIRIVA(R) to the lungs, with reduced depositionin the mouth and throat compared to a pressurised metered doseinhaler (pMDI). One study showed that 72% of all patients use pMDIsincorrectly and almost half (47%) have problems with coordinating useof the device.(9)

600 million people worldwide live with COPD and its prevalence ispredicted to rise making it the world's third leading cause of deathby 2020.(10),(11) It is estimated that up to 50% of Americans and 75%of Europeans with COPD are undiagnosed.(12),(13)

[LindaNY]

Thank you for that Larry. I hope it finally is approved for use here. Either that, or maybe we all should order it from ADC.

[the bear]

I think that this topic should be persued and each of us that use Spiriva should write to our health officials requesting quick approval for the Respirmat mister.

I honestly think the old Handihaler and the way it punctures the capsule leaves us with the inhalation of plastic particles from the process of breathing in deeply.

Lets get this letter writing underway now. Hugz, as ever, bear.

[LindaNY]

barrybrooks said:

I think that this topic should be persued and each of us that use Spiriva should write to our health officials requesting quick approval for the Respirmat mister.

I honestly think the old Handihaler and the way it punctures the capsule leaves us with the inhalation of plastic particles from the process of breathing in deeply.

Lets get this letter writing underway now. Hugz, as ever, bear.

I totally agree. Let's all write and now!!!

[larrynz]

When I came across the item on Euro approval, I thought thats interesting, to us and posted it here, the posts indicate I was right.
Now to share this I posted it on the new forum as well (Life With COPD), what surprised me was no replies.
I am still trying to work out why its interesting on one site but not on another?
We follow Europe so I hope to see it here soon, in fact I may well send it to our Minister of Health

[maryaz]

Hi Larry; I read your post on both forums. I had no comment on this. I do find it of interest very much. I believe maybe the fact it is in Europe and that means it would be some time before getting to the States. If this is the same thing, it only got one response on CI. The study will be a year. I read it all and just pass on comment sometimes.
www.clinicaltrials.gov/ct/show/NCT00387088

Altho, at this point there are so many new ones that I am getting confused now who has what and where.

It is my understanding that Spiriva just came out with some new kind of delivery method. I buy from ADC because I cannot afford the ones in the USA. I prefer the delivery from ADC. Much simplier. (see picture below). USA seems to like to complicate things anymroe.

I know there are preferred type of delivery. Linda indicated the mist is better. As things get closer and more real I look. Right now symbicort alone has really discouraged me. It was approved here in July, 2006 and just this month is coming out on market. Now it is a dosage that I cannot yet understand. Back to ADC which is where others get theirs and the numbers match better with the two components when taken separate.



I kept reading until now I AM TOTALLY CONFUSED. Maybe I don't have the patience for this tonight. Here is what I see and maybe you can straighten me out.

Respmist is a type of delivery system put out by the same company (Boehringer Ingel_ _ _) that put out Spiriva. The Trial above in Phase III is to study Spiriva by Respmist.

In reading Linda's link to Respmist, it is already out and working? Where, how, what? I don't know why every so often I hit a wall with one of these. Or is it just the literature that is out?

[LindaNY]

Mary, I understand your confusion because I'm totally confused by this too.

I found the links and read and still don't quite understand it and when it will finally be approved for the US.

It sounds great but only time will tell.

[larrynz]

As I said now its approved in Europe we may well follow, I have mailed our Minister of Health, did point out that the early trials were here in NZ, so just hope.
Next year is election year so they notice people a little more .

[Blossom/Jackie W.]

Well; I just went to the head of the horse....Boehring and asked about Canada, US And NZ....when/if available. I'll let you know what I hear.

[LindaNY]

Thanks Jackie, I was going to contact the company too, but you beat me to it.

Storms prevented me from being on the computer much today.

[the bear]

I am working on this too. I depend on Spiriva and Advair to keep me going. I have often wondered how many little particles of plastic I inhale using the Handihaler. The Advair works well with the Aerochamber for a fine mist to inhale.

I took the liberty of e-mailing our Prime Minister Stephen Harper and his Health Minister Tony Clement. I also e-mailed Premier Dalton McGuinty and his Health Minister George Smitherman in Ontario on Friday the 27th.

With Jackie getting in touch with Boehringer Ingelheim and my efforts to our health officials maybe we can speed up the process of this device being approved for distribution here.
Jackie and I could both use more help in contacting these guys, after all it is for our own benefit. If we do not fight for ourselves, who will??

[the bear]

To avoid confusion just google respimat. Everything is explained and there is a picture of the device.

[cocojax]

Bear thanks for that, here is one of the web addresses:

www.respimat.com/com/Main/services/disease/copd/index.jsp

Jackie and Bear just let me know if I can help, I feel the same way about the bits of plastic, plus I have a hard time inhaling enough.

[Blossom/Jackie W.]

I got a response from the manufacturer re: the current status....

"Currently there is no product yet available with Respimat in the US, Canada
or New Zealand.

There a number of products in advanced stage of development. In Germany there
is already a first product on the market. In Europe there is a second product
which achieved just two days ago European approval status. Boehringer
Ingelheim plans for start of marketing this product in a number of European
counties
later this year."

I have asked them to "guesstimate" availaiability. I don't know if they can but we'll see.

Incidentally when I first started using Spiriva, I too was concerned about inhaling the little piece of capsule from the puncture so I asked the RT at the clinic about it. She told me it would probably get caught in my mouth or throat...eventually it would dissolve. Even IF a got a piece in my lungs I'd probably cough it out.

[LindaNY]

Most of those capsules are made of a a gelatin and will dissolve sooner or later. I'm not worried.

www.capsugel.com/about/faq.php

[the bear]

I e-mailed the Boehringer Ingelheim office in Burlington, Ontario about the availability of the Respimat inhalation device. Here is the reply I got~~

"Unfortuately at this time, we cannot comment on the availability of the product in Canada."

Regards,

Medical Information

Boehringer Ingelheim Canada Ltd.

[cocojax]

I emailed [e-mail]
Tuesday July 31-2007

Currently I am using Spiriva, and my Dr. has advised to take 1 capsule but
two puffs once a day. I have trouble inhaling, I think Spiriva is a great
help with my symptoms. I was wondering when and if the Respimat Soft zmist
Inhaler would be available, or if there will be a trial in Canada I could
take part in. I am currently being assessed for a Double Lung Transplant, so
any easier delivery of medicine would be a great benefit.
Thanking you in advance
Ellen

I received this response this am

Dear Ellen,

Thank you for your interest in Respimat Soft Mist Inhaler. Currently there is
no product yet available in Respimat in Canada. There are a number of
products in advanced stage of development and a first product received
European approval status just a couple of days ago.

We forwarded you mail to our development team which is in charge of
international clinical trials. In case there are studies about to start in
Canada they will certainly get back to you.

Kind regards

Boehringer Ingelheim GmbH

At least it is some information.

[cocojax]

Dear Ms. ( I removed my last name )

Thank you for your recent email inquiring about participating in a Spiriva/Respimat trial. I am a trial manager for Canada. In order to determine if there is a trial currently available to you in your area I will need to know what city in Canada you are living in. Could you please send me the name of your current city/town and province?

When I have received this information, I will email you the nearest study site in your area (if there is one) that you can contact to assess your suitability to participate in one of our Spiriva/Respimat trials.

I look forward to hearing from you and thank you for your interest in Spiriva.

Kind regards,

Marianne Logger, APMR, CCRA
Clinical Monitor Local &Senior Research Associate

Boehringer Ingelheim Canada Ltd./Ltée
5180 South Service Road
Burlington, ON, L7L 5H4
Email. [e-mail]

This is the email I received after I told her where I lived.

Dear Helen,

Thank you for your reply. The closest centre that we have to you is in Scarborough. I have a left a message with the Scarborough site about your possible participation. As soon as I hear back from them I will let you know their decision. In the mean time, are you willing to travel to Scarborough if the site is able to make an appointment to see you?

Regards,

Marianne Logger

And this is what I responded.

Hi Marianne

Yes I would be willing to go for an appointment to Scarborough, keeping in mind that I am already taking Spiriva handihaler, I have never participated in a study before, would I have to go off my other medications, or is that something you would know? I am starting the assessment for a Double Lung transplant at Toronto General Hospital.

Ellen

[LindaNY]

As I said before, there is no need to worry about little bits of those capsules. Capsules are made of a pharmaceutical quality gelatin. They are not plastic.

www.capsule.com/about/faq.php

What are capsules made of?
Most capsules are made from gelatin. Gelatin is widely used in many food products such as puddings, desserts, marshmallows, chewable candies, glazes, whipped toppings, and dips. One popular consumer product is Jell-O® brand gelatin. In food applications, gelatin's ability to gel, thicken, stabilize, and aerate make it a highly desirable, nutritive, fat-free component. Gelatin also finds its way into many households in the form of cosmetics and toiletries, which utilize gelatin for its hypoallergenic and hydrating properties.

Gelatin itself is a mixture of water-soluble proteins derived primarily from collagen, which is the main naturally-occurring protein constituent of connective tissue. Gelatin is obtained from collagen by exposing animal skins and bones to a controlled extraction process. Gelatin comes in various types. Capsules are made from pharmaceutical-grade gelatin that has met the stringent requirements of the United States Pharmacopoeia and other international organizations that set standards for products that are used in medicines.

In addition to gelatin, capsules can also be created using non-animal sources suitable for addressing a variety of cultural and dietary requirements, including vegetarians, as well as patients with restricted diets. Two such non-animal capsule materials are pullulan and hypromellose. Pullulan, a water-soluble polysaccharide produced through a fermentation process, has achieved wide regulatory acceptance with its proven safety record. It has been in commercial production for more than 25 years, having numerous uses in the food and pharmaceutical industries. Hypromellose or HPMC is made from cellulosic raw materials and is also widely
accepted globally.

In the production of capsules, a thin film of either gelatin, pullulan or hypromellose is formed on stainless steel pins. As the gel forming film dries on the pin, it hardens to form the capsule that is later removed from the pin. Typically, two different size pins are used; one size pin for the body, and another larger-diameter size pin for the cap of a two-piece capsule. The capsule is then transferred to a capsule filling machine, which fills the capsule with either a powder, liquid, or paste.

[cocojax]

Linda this is for a clinical trial for the new respimat inhaler, nothing to do with the capsules, I just cannot breathe deep enough for the Spiriva to work good enough.

[LindaNY]

Sorry Ellen, I thought several of you had concerns with the little particles that break off and are inhaled. That's all.

There is no need to worry about those.