What is
learned in clinical trials? To advance medical and scientific
knowledge. Results may not help an individual participating in a clinical trial
but adds to overall knowledge for the larger group. And maybe our children and
grandchildren.
At the
April ILD Support Group last Tuesday, Archer Eller, the Clinical Trial Manager
gave a brief interesting example.
Reading
this blog, you may remember that my ILD Hypersensitivity Pneumonitis is the
only lung disease that does not develop in smokers. In a Phase 2 study, the HP
patients and a control group inhaled carbon dioxide and it was there that it
was discovered that smoking killed the antigens before they were allowed to
develop into HP. Interesting.
The next
clinical trial we discussed was the BIBF 1120 #1199.34 study first introduced
in this blog: http://livingwellwithabaddiagnosis.blogspot.com/2011/07/latest-drug-and-treatment-guidelines.html
This study
is a worldwide study involving an anti-fibrotic drug. Fibrosis does not just
happen in the lungs. It can also develop in the liver and kidneys. This drug
inhibits the pathways to stop fibrosis from developing.
In Phase 2,
100 people were randomly given a placebo, 100 on 50 mgs, 100 on 100 mgs and 100
on 150 mgs. They found the difference in the dose effect was 60%. A big deal.
In Phase 3,
500-600 people will be tracked. The number of qualified patients exceeded the
goal and the study is now closed waiting to begin by the end of the year. It
will be a 52-week trial.
We next
discussed the PANTHER study first discussed in this blog here: http://livingwellwithabaddiagnosis.blogspot.com/2011/08/research-regarding-pulmonary-fibrosis.html
When
problems appeared, I reported back in this blog: http://livingwellwithabaddiagnosis.blogspot.com/2011/10/scary-news-about-n-acetylcysteine-nac.html
Here is
latest on this study:
The study
began in Europe with 100 IPF patients on a placebo and 100 on N-acetycysteine
(NAC) which is an over the counter supplement. They were divided up into three
groups:
Placebo
NAC
Prednisone,
Imuran and NAC
Archer
reported that of the three people from this university hospital in the third
group of all three drugs, two dropped out due to side effects. They were
primarily suffering from hallucinations. While this study was happening, the
Data Safety Management Board discovered very serious problems in the third
group of iPF patients taking prednisone, Imuran and NAC. They pulled that part
of the study.
The other
two groups will continue with a trial for a 52-week study, which is still being
enrolled soon. After that year, the data will be reviewed and the results of
this study should be published in two years.
He also
briefly mentioned a new Phase 2 study of a twice a week injection in IPF
patients to treat fibrosis.
The next
Clinical Trial discussed was for connective tissue diseases like Scleroderma.
The National Institute of Health is running the 52-week study and will follow
it for two years afterwards. Scleroderma is an autoimmune disease but when it
develops in the lungs, it is the most serious aspect of the disease. The only
treatment now is a lung transplant.
Scleroderma
Lung Study I (SLS I) involved a doctor using Cellcept as an immunosuppressant
in 2 or 3 people with Scleroderma noticed that it was helping. He approached
the drug company Roche then did another small study with 7 patients. They all
did better.
SLS II had
a group of people placed on a placebo for an entire year. After the
year, half were given Cytoxan. The study was to compare Cellcept to Cytoxan for
an additional year. There was no placebo-only group. They are half way in their
enrollment and the results will be published approximately two years after the
study. If you have Scleroderma, please ask your doctor to include you in this
study.
Tomorrow’s
blog will discuss observational studies and bench work as well as a story about
a new person to our group.
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