I just read this from the website of the company bringing this to market, and it looks super encouraging!
BRONCHITOL CYSTIC FIBROSIS DOSE TRIAL RESULTS POSITIVE
Bronchitol demonstrates dose-related improvements in lung function of cystic
fibrosis patients.
Speciality pharmaceutical company Pharmaxis (ASX<img src="i/expressions/face-icon-small-tongue.gif" border="0">XS, NASDAQ<img src="i/expressions/face-icon-small-tongue.gif" border="0">XSL) today
announced results from its Phase II trial, DPM-CF-202, in subjects with cystic fibrosis.
The trial achieved its primary end point of demonstrating a dose dependent improvement
in lung function as measured by FVC (forced vital capacity) and FEV1 (the amount of air
that can be forcibly exhaled in 1 second). At the end of the two-week Bronchitol treatment
periods, changes in lung function were as follows:
?? 400 mg treatment group: FEV1 increased by 8.6% (139 mls, p=0.0006 vs 40 mg)
?? 240 mg treatment group: FEV1 increased by 4.6% (87 mls)
?? 120 mg treatment group: FEV1 increased by 3.7% (42 mls)
?? 40 mg treatment group: FEV1 decreased by -1.6% (-33 mls)
FVC changed by +7.9% on 400 mg (p=0.0004 vs 40 mg), +3.9% on 240 mg, +1.5% on
120 mg and -0.6% on 40 mg.
Pharmaxis Chief Executive Officer Alan Robertson said "The excellent result from this trial
reaffirms that the 400 mg Bronchitol dose being used in the Phase 3 trials is optimal for
its clinical effectiveness. We look forward to the results from the ongoing Phase 3 studies
and to bringing Bronchitol to the market as rapidly as possible."
The study was an open, randomised comparison of 400mg, 240 mg, 120 mg and 40 mg of
Bronchitol in 48 patients with cystic fibrosis at 12 centres across Canada and Argentina.
Bronchitol was administered twice a day for 14 days in a crossover design.
Secondary endpoints of the study included other spirometry and quality of life measures.
These measures also showed a positive effect for 400 mg Bronchitol on MMEF (maximum
mid expiratory flow) and the respiratory domain of the cystic fibrosis quality of life
questionnaire (CFQR).
Additionally, no serious adverse events emerged during the 400 mg treatment period and
the adverse event profile was similar across all doses.
BRONCHITOL CYSTIC FIBROSIS DOSE TRIAL RESULTS POSITIVE
Bronchitol demonstrates dose-related improvements in lung function of cystic
fibrosis patients.
Speciality pharmaceutical company Pharmaxis (ASX<img src="i/expressions/face-icon-small-tongue.gif" border="0">XS, NASDAQ<img src="i/expressions/face-icon-small-tongue.gif" border="0">XSL) today
announced results from its Phase II trial, DPM-CF-202, in subjects with cystic fibrosis.
The trial achieved its primary end point of demonstrating a dose dependent improvement
in lung function as measured by FVC (forced vital capacity) and FEV1 (the amount of air
that can be forcibly exhaled in 1 second). At the end of the two-week Bronchitol treatment
periods, changes in lung function were as follows:
?? 400 mg treatment group: FEV1 increased by 8.6% (139 mls, p=0.0006 vs 40 mg)
?? 240 mg treatment group: FEV1 increased by 4.6% (87 mls)
?? 120 mg treatment group: FEV1 increased by 3.7% (42 mls)
?? 40 mg treatment group: FEV1 decreased by -1.6% (-33 mls)
FVC changed by +7.9% on 400 mg (p=0.0004 vs 40 mg), +3.9% on 240 mg, +1.5% on
120 mg and -0.6% on 40 mg.
Pharmaxis Chief Executive Officer Alan Robertson said "The excellent result from this trial
reaffirms that the 400 mg Bronchitol dose being used in the Phase 3 trials is optimal for
its clinical effectiveness. We look forward to the results from the ongoing Phase 3 studies
and to bringing Bronchitol to the market as rapidly as possible."
The study was an open, randomised comparison of 400mg, 240 mg, 120 mg and 40 mg of
Bronchitol in 48 patients with cystic fibrosis at 12 centres across Canada and Argentina.
Bronchitol was administered twice a day for 14 days in a crossover design.
Secondary endpoints of the study included other spirometry and quality of life measures.
These measures also showed a positive effect for 400 mg Bronchitol on MMEF (maximum
mid expiratory flow) and the respiratory domain of the cystic fibrosis quality of life
questionnaire (CFQR).
Additionally, no serious adverse events emerged during the 400 mg treatment period and
the adverse event profile was similar across all doses.