Friday, November 2, 2007

This Week's COPD News With Joan Costello

Excerpts from this Friday's newsletter from the COPD Support Family Of Support Programs
Read the newsletter in it's entirety on the website by clicking Here.

Volume 7, Issue 47
November 2, 2007

You know those salmon we have here in the Northwest? You’ve heard the stories about how they travel upstream to spawn. They are determined little suckers, and it is their natural instincts to do what they do. They will beat themselves silly just to achieve their goal. As humans, we are often just as determined in the way we live our lives. We are sometimes driven by instinct, usually by our upbringing, often by our goals and plans for life.

I have always been one such individual. The words stubbornness, determination and drive come to mind. That’s exactly why it was so disturbing for me when my body stopped cooperating with my mind, my ambition and my dreams. Seems to me it’s the ultimate betrayal - my own body!

Also In This Issue

"My name is Jennifer Fernandez and I am with a company called RESolutions which is a patient recruitment firm out of San Diego California. Our mission is to bring potentially life altering information about clinical trials to individuals in need. I would appreciate the opportunity to share information through your newsletter about an ongoing national clinical trial for individuals with severe emphysema."

Jennifer attached the following information.

What is IBV® Valve System and Trial?The goal of this clinical trial is to determine the safety and effectiveness of an investigational device, which is placed in the lungs of people with severe emphysema. These small valves are placed into portions of the lungs. The valves are placed without an incision using a flexible bronchoscope. These small umbrella shaped, one-way valves are designed to move air from the diseased areas of the lungs to healthier portions of the lung. They are intended to improve overall health and quality of life. Although the valves are intended to be permanent, they are designed to be removed, if necessary.

How Does the Clinical Trial Work?
All Participants in this Clinical Trial Will:
-Receive a diagnostic bronchoscopy that will allow an expert in lung health to evaluate their lungs.
-Be under the care of a highly qualified lung doctor for the entire time they are in the trial, regardless of whether they are in the Treatment Group or the Control Group.
-Receive regular periodic check-ups and health assessments throughout the 6 month trial period.
-The procedure, all testing, and doctor visits are provided at no cost to participants of both the IBV Valve Treatment Group and the Control Group.

After the Trial is Completed-At the completion of their 6-month visit, participants will be told if they were assigned to the Treatment Group or the Control Group. If participants were assigned to the group that did not receive valves (the Control Group), they will be given the option to be re-evaluated by the clinical trial doctor, to determine if they can have valve treatment. All participants will receive professional care and follow-up at no cost.

Am I a candidate?To learn about the trial including participating physicians and to complete a pre-screening questionnaire to determine initial eligibility, you can log onto OR call toll-free 1-877-547-8839

One of the things I noticed in the comments in the inhaler changeover is that many of you are using your rescue inhalers often, daily even. Also, there is a feeling that the new HFA ones aren't working to help ease asthma symptoms and in some cases making you feel worse! I was thinking there may be a few reasons for that.

First, your old CFC inhaler may have stopped working a long time ago; it's my understanding from my pulmonologist that the more you use your rescue inhaler the less it continues to work. Does this sound familiar?

Second, the new inhalers need to be cleaned more often; the powder is fine and clogs the system quicker than the old CFC ones. [Did you clean your old inhalers?] If you're using the new one every day and not cleaning them you may not be getting the full dose of medication.

Third, and this is a crucial point, rescue inhalers are for emergencies, not daily use. If you're having asthma symptoms daily, you need daily medication
but your rescue inhaler isn't it.


MAP Pharmaceuticals, Inc. , announced the initiation of a Phase 2a clinical trial evaluating MAP0005 for the potential treatment of asthma and COPD. The Phase 2a clinical trial is a randomized, open-label, active-controlled, crossover, safety and dose response study investigating the pharmacokinetics and pharmacodynamics of MAP0005 in asthmatic patients. The trial compares two different doses of MAP0005 with one dose of a commercially marketed combination product, alladministered by inhalation. The primary endpoints of the trial are the change in forced expiratory volume in one second (FEV1) from baseline, the time to maximum change in FEV1 and the plasma levels for the inhaled corticosteroid.

MAP Pharmaceuticals is developing the Tempo inhaler, a novel pressurized metered dose inhaler that synchronizes the discharge of drug with thepatient's breathing cycle, which can be optimized for each therapy based on desired delivery. It is designed to dispense drug in an efficient andconsistent manner to minimize dose-to-dose differences in and between patients. The inhaler contains a dose counter that can lock out after amaximum number of doses.

Every year in the United States, 30 million dispensing errors out of 3 billion prescriptions occur at outpatient pharmacies, according to the National Patient Safety Foundation. Some errors are minor. Some patients catch easily. But others can be serious. "There's been a tremendous increase in fatal pharmacy errors over the past 20 years," said David Phillips, a sociology professor at the University of California-San Diego who has
studied this issue...." Why the increase? Phillips said more health care is happening outside hospitals, putting more of a burden on outpatient pharmacists. Here, from Phillips and other experts, are ways toavoid becoming a victim:

Don't get a prescription filled at the beginning of the month. Phillips' research shows that in the first few days of each month fatalities due to medication errors rise by as much as 25 percent above normal. The reason:
Social Security checks come at the beginning of the month. "Quite a number of people can't afford to get their medicines until the Social Security check comes in, so at the beginning of the month they turn up in abnormally large numbers and swamp the pharmacists," Phillips said. "When pharmacists are busy, they make more mistakes." Of course, it's not always possible to wait a week or two to get a prescription, but Phillips advises to do so if you can.

Open the bottle at the pharmacy. Mitch Rothholz, a spokesman for the American Pharmacists Association, said pharmacy errors aren't common, but that there are things patients can do to make sure the medicine inside a bottle is the right drug.

He said opening the bottle right at the pharmacy and showing the pills to the pharmacist is one safeguard. Another: If it looks different than the medicine you've taken before, or you have any questions, don't be afraid to ask the pharmacist. Don't be in a rush.

Many asthma and COPD patients are now being treated with inhaled corticosteroid/long-acting beta2agonist fixed-dose combinations, a lifecycle management strategy generating high sales from a relatively low investment. However, the lack of truly novel drug targets means that other unmet needs in asthma and COPD are being overlooked by the leading players.

Patients suffering from respiratory diseases ... are increasingly being treated with fixed-dose combination inhalers. The combination products are popular for several reasons, including improved patient compliance, simplified disease management and the assurance of bronchodilator and steroid co-administration. Non-adherence to treatment is a significant problem in asthma and COPD, especially in the later stages of disease, when patients have a multitude of drugs to deal with and treatment regimes can become confusing. Patients show a specifically low compliance when it comes to their ICS (inhaled corticosteroid/long-acting beta2-agonist) medication because, unlike a bronchodilator, it does not give them immediate relief.
However, the regular use of steroids is key to treating the underlying inflammatory process of asthma and COPD. The automatic intake of the ICS alongside the bronchodilator, improving disease management for both patients and physicians, is a major advantage of combination drugs.

Although the introduction of fixed dose ICS/LABA combination products has meant an improvement in the standard of treatment for the majority of asthma and COPD patients, there still remains a high level of unmet need, especially in the treatment of COPD. Key examples include the lack of efficacious anti-inflammatories for COPD (current therapies neither arrest nor reverse inflammation and the resulting decline in lung function), finding better ways to prevent and control asthma and COPD exacerbations, and developing therapies for the 10% of refractory asthma patients whose symptoms cannot be controlled with currently available drugs.

To Read Many More Articles From This Week's Newsletter, Please Visit The COPD Support Website.

JOIN US? Subscription to this Newsletter is free and we hope that it serves your needs. For more Newsletter information, go to: