Friday’s COPD Newsletter from COPD Support, Inc.
Volume 9, Issue 52
November 27, 2009
Joan Costello, Editor
CLINICAL INVESTIGATIONS 101: WHAT ARE THE PHASES OF TRIALS?
Health and Science Examiner. Elizabeth Anderson. Clinical trials are
usually divided into different phases. Each phase has a specific design
and is conducted to gather particular information about the material or
modality being investigated. Pre-clinical tests involve animal studies
and in vitro tests, performed strictly in a laboratory environment.
Phase I Trials
This phase is for drugs or treatments never used in humans (before) and
is designed to evaluate potential side effects and safe dose ranges.
They usually involve small numbers of healthy volunteers, so any side
effects will not be confused with existing conditions…studies are
usually brief and involve small numbers of patients, who are monitored
closely because of risks…often referred to as safety trials…studies
are not randomized. All volunteers received the active treatment, not a
placebo. Volunteers and investigators are aware of the treatments
involved.
Phase II Trials
After a drug or treatment is shown to be safe and well tolerated, Phase
II trials begin to establish *efficacy. Studies involve larger groups of
patients who have the disease or the potential for the disease being
studies. These trials can be randomized, where the active treatment is
compared to a placebo, but not always. Safety evaluations continue in
this phase.
Phase III Trials
If the investigational treatment is effective in Phase II trials, Phase
III trials may begin. Phase III trials expand on the success of earlier
trials by evaluating hundreds or even many thousands of patients. Phase
III trials are always randomized. Usually, neither the investigator nor
the volunteer is aware of whether they are getting an active agent, a
placebo, or an existing standard treatment.
Phase IV Trials
These trials are referred to as Post-Marketing Trials because they are
conducted after a treatment has been on the market, providing valuable
data on long-term usage. These studies can reveal side effects not
apparent during Phase III and also identify new uses for existing
treatments.
http://www.examiner.com/x-13868-Health-and-Science-Examiner~y2009m6d19-Phases-of-Clinical-Investigation-Trials
*Power or capacity to produce a desired effect; effectiveness
ALSO IN THIS ISSUE
-UNIVERSITY OF IOWA STUDIES COPD
-LUNG TRANSPLANTATION IN THE OLDER ADULT
-LUNG FLUTE , ACAPPELLA, THE VEST
-MSU PROFESSOR WINS RESEARCH FELLOWSHIP FOR COLD WEATHER MASK
-GAINING A BETTER PICTURE OF LUNG DISEASE
-FDA WARNS OF BACTERIA IN VICKS NASAL SPRAY
-MISCELLANEOUS
~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<
SOURCES: News items summarized in The COPD-NEWS are taken from secondary
sources believed to be reliable. However, the COPD Family of Services
does not verify their accuracy.
~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<
UNIVERSITY OF IOWA STUDIES COPD
By Becky Ogann. Watch the video to see Dr. Karl Thomas from University
of Iowa Hospitals and Clinics talk about the the IBV valve study being
conducted at UIHC.
http://www.kcrg.com/news/local/71788532.html
LUNG TRANSPLANTATION IN THE OLDER ADULT
At present, lung transplantation is the preferred treatment option for a
variety of end–stage pulmonary diseases. Remarkable progress has
occurred through refinement in technique and improved understanding of
transplant immunology and microbiology. Elderly lung transplant
recipients usually undergo transplantation for COPD or idiopathic
pulmonary fibrosis and face unique challenges. It is increasingly
evident that ‘biologic age’ is more important than actual recipient
age. Postoperative immunosuppression regimens and education require
greater individualization in elderly adults owing to the increased risk
for infection and greater risk involved with complications.
The first long-term, successful, human-isolated lung transplant was
performed in 1983 by the Toronto Lung Transplant Group. Two and a half
decades have passed since this landmark procedure and almost 19,000 lung
transplants have been performed. At present, lung transplantation is the
preferred treatment option for a variety of end-stage pulmonary
diseases. Remarkable progress has occurred through refinement in
technique and improved understanding of transplant immunology and
microbiology.
Aging Health is a subscription only site, but perhaps you can get the
full article at the library if interested.
http://www.futuremedicine.com/doi/abs/10.2217/ahe.09.77
~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<
MEDICAL DECISIONS. Your physician should be consulted on all medical
decisions. New procedures or drugs should not be started or stopped
without such consultation. While we believe that our accumulated
experience has value, and a unique perspective, you must accept it for
what it is…the work of COPD patients. We vigorously encourage
individuals with COPD to take an active part in the management of their
disease. They do this through education and by sharing information and
thoughts with their primary physician and pulmonologist. However,
medical decisions are based on complex medical principles and should be
left to the medical practitioner who has been trained to diagnose and
advise.
~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<
LUNG FLUTE , ACAPPELLA, THE VEST
In last week’s newsletter we published that Lung Flute (a mucous
clearing device) FDA approval was expected any day. It generated a
conversation about other methods of clearing mucous. The following are
excerpts from the COPD Digest and Newsletter emails.
Ricky: This site is for the Acapella that I use. I think it does the
same thing, is adjustable, and lasts forever. Got mine from MUSC when I
was hospitalized one time. Just my opinion.
http://www.smiths-medical.com/catalog/bronchial-hygiene/acapella/acapella.html
Editor: Thank you. I am not familiar with the Acapella and looked at the
videos of both products. I do not have any experience with these items,
but perhaps others can compare the two.
A Chicago newspaper ran a video of the Lung Flute. Here’s the link.
http://www.suntimes.com/entertainment/-1,112009wtfg.photogallery?index=8
And here’s a YouTube link to the Acapella:
http://www.youtube.com/watch?v=K_Hu3f3d5no
Peche: I also use the Acapella and have done so for several years. It’s
made all the difference in my breathing, I had tried other “gadgets” but
none did what this one did. I bought 3 of them so I could have one in
each area of my house as I never knew when I would find it almost
impossible to breathe. The Acapella always cleared the mucus that was
making it impossible to breathe.
Tek/CA: My family has snit fits when they catch me blowing up balloons.
They think I am squandering what precious little breath I have. This
tickles me no end because I feel so much better after a balloon blowing
session. In fact, instead of bubble baths, my grand kids, who are very
allergic to so many things including sudsing cleansing agents, get
balloon baths here instead of bubble baths and that’s ever so much more
fun. We can practice math, color composition, size comparison… all
sorts of things. I say balloon blowing is fantastic therapy and beyond.
Richard/NY: I’ve heard both encouragement and warnings about blowing up
balloons. Some doctors and RT’s still recommend it, but others say that
there might be too much resistance involved for some lungs to handle,
and blowing up balloons may cause damage. I do agree that getting all
that trapped air out really does make a difference. I noticed that a
long talk, when I repeatedly push out trapped air so I can finish a
sentence, really works wonders for me. It took me many years to realize
this, because of my tendency to avoid talking when SOB. I don’t like
using my little resistance trainer - just another thing to disinfect.
Tek/CA: Thanks for this info, but what is the damage that could occur?
It seems that when the blowing gets tough, I automatically rest for a
while. I’d sure hate to give up this fun activity. Hopefully I’ll
remember to ask my pulmo about it.
Richard/NY: To be honest, I don’t know what type of damage, if any,
blowing up balloons might cause. I just searched a bit to try to answer
that question, but couldn’t find an answer. What I did find is that Dr.
Tom Petty (says) it does not harm the lungs, period. A respiratory
therapist friend with COPD, now deceased, and the most knowledgeable
person about COPD I’ve ever known, warned against it and favored a
harmonica. Common sense tells me that you should use reasonable force
when blowing up balloons and, like most things in life, not overdo it.
Kaysok: Five or six years ago every one was taking up playing the
Harmonica, another form of forced exhalation. The blowing up of balloons
twice a day and whistling to music was also discussed. From this I
assumed people are feeling relief from continuous exhalation therapy.
Patrecia: Hi, I am butting in, I got one of these given to me in the
hospital, I have the expensive machine called the Vest in my home and I
like this better…easier too
Ricky: What do you like better, The Vest or the Acapella?
Editor: If cost is a factor, I believe the cost of The Vest airway
clearance system is between $13,000 and $16,000.
The cost of the Acapella device is around $70.00
The final cost of the Lung Flute is unknown (not on the market yet) but
estimated to be $40.00
~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<
COMMERCIAL FREE: We do not accept any paid advertising. Any
corporations, products, medicines (prescription or non) mentioned in
this newsletter are for informational purposes only and not to be
construed as an endorsement or condemnation of same.
~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<
MSU PROFESSOR WINS RESEARCH FELLOWSHIP FOR COLD WEATHER MASK
Montana State University exercise physiology professor John Seifert will
receive a research fellowship at the American Association for
Respiratory Care’s 55th International Respiratory Congress, to be held
Dec. 5-8 in San Antonio, Texas.
Seifert is receiving the award based on his research and paper, “The
Cardiopulmonary Effect of Heat and Moisture Exchange Mask on COPD
Patients during Cold Exposure.” Seifert collected data on a copper-lined
face mask to be used by COPD patients during cold weather. Seifert said
that the face mask warms and humidifies inhaled cold air, which can have
a negative effect on the cardiopulmonary system.
http://www.montana.edu/cpa/news/nwview.php?article=7779
Dr. Seifert’s full report:
It has been well established that cold air inhalation exacerbates
cardiopulmonary stress in Chronic Obstructive Pulmonary Disease (COPD)
patients. The frequency of exacerbations increases during the winter
which will, ultimately, decrease pulmonary function. As pulmonary
function decreases, there is a concomitant decrease in the quality of
life because most outdoor activities are eliminated. Thus, minimizing
cold air inhalation is an important factor in maintaining functional
capacity of these patients. A heat and moisture exchange mask (HME)
warms and humidifies cold, dry inspired air via latent heat exchange.
However, it is not known if COPD patients would benefit from such a
mask. The purpose of this study was to investigate the influence of an
HME on the cardiopulmonary responses in COPD patients during 60 minutes
of cold exposure.
http://tinyurl.com/yklgndu
GAINING A BETTER PICTURE OF LUNG DISEASE
With 600 million people living with COPD, researchers have yet to find
any real treatment or cure. However, Grace Parraga of Robarts Research
Institute is using various imaging techniques to learn more about the
disease. Parraga is a scientist in the Imaging Research Laboratories.
Currently, Parraga and her collaborators at Western hold two large
grants valued at $2.5 million from the Canadian Institutes of Health
Research… to characterize COPD using Magnetic Resonance Imaging and to
compare three different types of lung imaging in COPD patients over
time.The idea is that if we can understand the structural and functional
imaging changes that happen over time, we can start to understand the
patients in a different way, with the potential to change the way they
are treated.
Parraga and her collaborators believe that two major COPD groups exist:
those with dysfunctional airways, and those with lung tissue damage. She
says current methods of evaluating COPD don’t consider the differences
imaging methods can detect and therefore these often are not predictive
of how patients feel and how their disease progresses
http://communications.uwo.ca/com/western_news/stories/gaining_a_better_picture_of_lung_disease_20091120445295/
FDA WARNS OF BACTERIA IN VICKS NASAL SPRAY
Several lots of Vicks Sinex nasal spray have been recalled because of
bacteria found in the solution during a quality control inspection, the
FDA announced. Drug manufacturer Proctor and Gamble issued the voluntary
recall, citing possible contamination by B. cepacia bacteria. Though no
adverse events have been reported, the FDA cautioned the tainted lots
might cause serious infection in patients with compromised immune
systems or chronic lung conditions. The agency said the bacteria pose
little risk to healthy individuals.
Product lot numbers are listed on the outer carton and bottle of the
spray. Lots included in the recall are:
#9239028831 (Vicks Sinex Vapospray) in the U.S.
#9224028832 (Vicks Sinex Micromist Aqueous Nasal Spray Solution) in the
U.K.
#9224028833 (Wick Sinex Schnupfenspray Dosiersystem) in Germany
Though the effected lots are being removed from store shelves, patients
should discard any product with a matching lot number. Patients with
recalled samples may request a refund or replacement coupon by calling
Proctor and Gamble.
http://tinyurl.com/ylz7c6r
~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<
JOIN US? Subscription to this Newsletter is free and we hope that it
serves your needs. For more Newsletter information, go to:
http://copd-support.com/signup-news.html
The Newsletter, like all other endeavors of the Family of COPD Support
Programs, is provided to you by COPD-Support, Inc. a non-profit member
organization with IRS designation 501(c)(3). If you would like to be
involved and help us provide these programs to the individuals who
benefit from them, please consider joining us as a member. Further
information is available at:
http://copd-support.com/membership.html
~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<>~<
MISCELLANEOUS
The magic of words.
Forwarded by JohnW/MN: Welcome to Wordsmith, the home of:
*A.Word.A.Day: discover the magic of words
*Internet Anagram: find the wisdom of anagrams
*Wordsmith: Chat live chat with authors, lexicographers, thinkers, and
more
* The Word lookup services via email
http://wordsmith.org/
Singing Horses
Wait for the entire screen to load up with all four horses and a fence
in front of them. Turn the speakers on. Then click on each horse.
Re-click on any horse to make it turn off or turn it back on again.
http://www.angelfire.com/ak2/intelligencerreport/singing_horses.html
Write your Story
Fill in the blanks and let the computer tell your story.
http://www.angelfire.com/ak2/intelligencerreport/writestory1.html
Numbers Game
http://www.angelfire.com/ak2/intelligencerreport/numbersgame.html
Until next Friday,
Joan Costello, Editor
Web version of the News: http://copd-support.com/news.html
Archives at: http://home.ease.lsoft.com/archives/copd-news.html
Related posts:
- Friday’s COPD Newsletter from COPD Support, Inc. Volume 10, Issue 39 August 27, 2010 Richard D....
- Friday’s COPD Newsletter from COPD Support, Inc. Volume 10, Issue 38 August 20, 2010 Richard D....
- Friday’s COPD Newsletter from COPD Support, Inc. Issue 38, Volume 9, August 21, 2009 Joan Costello,...
- Friday’s COPD Newsletter from COPD Support, Inc. Volume 10, Issue 02 December 11, 2009 Joan Costello,...
- Friday’s COPD Support Newsletter Volume 10, Issue 19 April 9, 2010 Joan Costello,...
Related posts brought to you by Yet Another Related Posts Plugin.
November 28, 2009
Tags: COPD newsletter, COPD Support Inc., COPD Support newsletter Posted in: Friday's COPD Newsletter
Leave a Reply