bronchitol

rvm1212

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/assets/pdf/2010/2010_01_27_Pharmaxis_Quarterly_25_Dec_2009.pdf
">http://www.pharmaxis.com.au/as...terly_25_Dec_2009.pdf
</a>Has anyone been on the trial?
hope it gets approved soon!

husband with cf, 37 years old. diagnosed at 34.
 

rvm1212

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/assets/pdf/2010/2010_01_27_Pharmaxis_Quarterly_25_Dec_2009.pdf
">http://www.pharmaxis.com.au/as...terly_25_Dec_2009.pdf
</a>Has anyone been on the trial?
hope it gets approved soon!

husband with cf, 37 years old. diagnosed at 34.
 

rvm1212

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/assets/pdf/2010/2010_01_27_Pharmaxis_Quarterly_25_Dec_2009.pdf
">http://www.pharmaxis.com.au/as...terly_25_Dec_2009.pdf
</a>Has anyone been on the trial?
hope it gets approved soon!

husband with cf, 37 years old. diagnosed at 34.
 

rvm1212

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/assets/pdf/2010/2010_01_27_Pharmaxis_Quarterly_25_Dec_2009.pdf
">http://www.pharmaxis.com.au/as...terly_25_Dec_2009.pdf
</a>Has anyone been on the trial?
hope it gets approved soon!

husband with cf, 37 years old. diagnosed at 34.
 

rvm1212

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/assets/pdf/2010/2010_01_27_Pharmaxis_Quarterly_25_Dec_2009.pdf
">http://www.pharmaxis.com.au/as...terly_25_Dec_2009.pdf
</a><br />Has anyone been on the trial?
<br />hope it gets approved soon!
<br />
<br />husband with cf, 37 years old. diagnosed at 34.
 

triples15

Super Moderator
Hi,

I'm currently in the phase 3 mannitol(Bronchitol)study. I'm still in the first 26 week period which is blind, so I don't know whether I'm receiving the drug or the placebo. I have a definite opinion about which I'm getting, but I'm unfortunately not allowed to discuss it. After the initial 26 week blinded period there is an open-label phase where everyone in the study will receive the drug, so that's exciting.

I too am hopeful for this drug!
 

triples15

Super Moderator
Hi,

I'm currently in the phase 3 mannitol(Bronchitol)study. I'm still in the first 26 week period which is blind, so I don't know whether I'm receiving the drug or the placebo. I have a definite opinion about which I'm getting, but I'm unfortunately not allowed to discuss it. After the initial 26 week blinded period there is an open-label phase where everyone in the study will receive the drug, so that's exciting.

I too am hopeful for this drug!
 

triples15

Super Moderator
Hi,

I'm currently in the phase 3 mannitol(Bronchitol)study. I'm still in the first 26 week period which is blind, so I don't know whether I'm receiving the drug or the placebo. I have a definite opinion about which I'm getting, but I'm unfortunately not allowed to discuss it. After the initial 26 week blinded period there is an open-label phase where everyone in the study will receive the drug, so that's exciting.

I too am hopeful for this drug!
 

triples15

Super Moderator
Hi,

I'm currently in the phase 3 mannitol(Bronchitol)study. I'm still in the first 26 week period which is blind, so I don't know whether I'm receiving the drug or the placebo. I have a definite opinion about which I'm getting, but I'm unfortunately not allowed to discuss it. After the initial 26 week blinded period there is an open-label phase where everyone in the study will receive the drug, so that's exciting.

I too am hopeful for this drug!
 

triples15

Super Moderator
Hi,
<br />
<br />I'm currently in the phase 3 mannitol(Bronchitol)study. I'm still in the first 26 week period which is blind, so I don't know whether I'm receiving the drug or the placebo. I have a definite opinion about which I'm getting, but I'm unfortunately not allowed to discuss it. After the initial 26 week blinded period there is an open-label phase where everyone in the study will receive the drug, so that's exciting.
<br />
<br />I too am hopeful for this drug!
 

average

New member
The Europeans have voted bronchitol down and the company is in the process of appealing the decision. It appears that while bronchitol demonstrated a > 7% increase in FEV1 over 26 weeks against baseline in over 300 patients, that there was a strong placebo responce particularly in adolecents. The strong placebo responce was because placebo was 50 mg of bronchitol taken twice daily while people on the drug took 400 mg twice daily. The low dose or placebo made people cough and actually also increased FEV1, meaning the clinical benefit or improvement in lung function was just 3.8% over 300 patients. How do you go on both placebo and on the 400 mg dose?
 

average

New member
The Europeans have voted bronchitol down and the company is in the process of appealing the decision. It appears that while bronchitol demonstrated a > 7% increase in FEV1 over 26 weeks against baseline in over 300 patients, that there was a strong placebo responce particularly in adolecents. The strong placebo responce was because placebo was 50 mg of bronchitol taken twice daily while people on the drug took 400 mg twice daily. The low dose or placebo made people cough and actually also increased FEV1, meaning the clinical benefit or improvement in lung function was just 3.8% over 300 patients. How do you go on both placebo and on the 400 mg dose?
 

average

New member
The Europeans have voted bronchitol down and the company is in the process of appealing the decision. It appears that while bronchitol demonstrated a > 7% increase in FEV1 over 26 weeks against baseline in over 300 patients, that there was a strong placebo responce particularly in adolecents. The strong placebo responce was because placebo was 50 mg of bronchitol taken twice daily while people on the drug took 400 mg twice daily. The low dose or placebo made people cough and actually also increased FEV1, meaning the clinical benefit or improvement in lung function was just 3.8% over 300 patients. How do you go on both placebo and on the 400 mg dose?
 
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