Navigation Links
12 Month Phase 3 Trial Finds Bronchitol Safe in Bronchiectasis
Date:8/19/2008

SYDNEY, Australia, Aug. 20 /Xinhua-PRNewswire-FirstCall/ -- Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that the Phase 3 clinical trial evaluating the long term safety of Bronchitol in subjects with bronchiectasis has concluded with no serious adverse events attributed to the drug following 12 months of treatment.

A total of 123 subjects started treatment with 320 mg Bronchitol twice per day and 99 subjects completed the full 12 months of the trial. Of the 24 withdrawals, only seven were a result of adverse events (three related to lung infections and two related to cough).

The most common adverse events attributed to treatment were cough in 9% of the subjects and sore throat in 5%. Other reported adverse events related to treatment were infrequent, mild in severity and in most cases were a consequence of the underlying disease.

Pharmaxis CEO Alan Robertson said: "Pharmaxis intends to file a marketing application in Australia for Bronchitol as soon as possible now that this study has concluded satisfactorily.

"Bronchitol has created a great deal of interest among people suffering with bronchiectasis and we continue to respond to requests from trial participants and others interested in Bronchitol. We are looking forward to bringing Bronchitol to the market place and are delighted this trial has concluded successfully."

This 12 month treatment period was an open label extension to a three month efficacy trial which reported in the second half of 2007.

The conclusion from this trial is that Bronchitol improves quality of life and mucus clearance following three months of treatment and is safe and well tolerated following 12 months of treatment. The open label component of the trial reported today supports the efficacy reported earlier in the blinded phase of the trial.

Bronchitol is being initially developed as a twice daily inhalation therapy for people with the incurable lung condi
'/>"/>

SOURCE Pharmaxis Ltd
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
2. Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study
3. XTENT Announces Positive Six-Month CUSTOM III Trial Data Presented at EuroPCR Meeting
4. Alseres Pharmaceuticals Announces 12 Month Interim Results from the Phase I/IIa Cethrin(R) Clinical Trial in Acute Spinal Cord Injury
5. New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for 12 Months
6. Vical Promotes Melanoma Awareness Month With Allovectin-7(R) Video Report
7. Update From Mipomersen Extended Dosing Study Continues to Show That Mipomersen Is Well Tolerated and Maintains Activity in Patients Treated for Up to 16 Months
8. New Trial Presented at AAAAI Reports that the Growth of Children 2-5 Years Old with Year-Round Allergic Rhinitis Continued According to Normal Age-Adjusted Distribution Over a 6-Month Treatment with Nasacort AQ
9. Clinical Update - Decapeptyl(R)/Trelstar(R) 6-Month Formulation in Advanced Prostate Cancer
10. Phase III Data Published for Once Monthly Dose of Risedronate to Treat Postmenopausal Osteoporosis
11. Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/19/2008)... critical enzyme,s regulation may hold key to unde...s , , MEMPHIS, Tenn., Nov. 19 /PRNewswire-U...esearch Hospital have gained new insights into reg...led calpains. , , As the cell,s molecular ...processes, including the movement of cells in tiss...
(Date:11/18/2008)..., make a donation or send a Christmas Seals e-card...wire/ -- Millions will receive Christmas Seals in ... Association. These decorative holiday stamps are ...k to 1907 when the Lung Association led efforts to...s alive today have no vivid memories of how widesp...
(Date:11/13/2008)...tCall/ -- Hologic, Inc.,(Nasdaq: HOLX ), a leadin...diagnostics, medical imaging systems and surgical ... of women, today announced the results of the,Cerv...vista HPV high-risk,test is currently under review...ched in the European Union (EU) early in 2009. The...
(Date:11/12/2008)...r 12 Surgeons,at the University of...nt-specific CTA data can be converted to an endova...with high face validity. The surgeons,"strongly ag...low,increased patient safety and efficiency of in...roscopy time and the amount of contrast used, and,...
Breaking Medicine Technology:New Insight Into the Controls on a Go-To Enzyme 2New Insight Into the Controls on a Go-To Enzyme 3American Lung Association Celebrates 101st Annual Christmas Seals Campaign 2Hologic Releases the Results of the Cervista(TM) HPV Clinical Trials 2Hologic Releases the Results of the Cervista(TM) HPV Clinical Trials 3Hologic Releases the Results of the Cervista(TM) HPV Clinical Trials 4Vascular Surgeons Agree: Case Rehearsal Improves Outcomes 2Researchers discover cells quality control mechanism 4249 1Researchers discover cells quality control mechanism 4249 2South African Farmers Increase Plantings of Genetically Modified Crops 6799 1South African Farmers Increase Plantings of Genetically Modified Crops 6799 2South African Farmers Increase Plantings of Genetically Modified Crops 6799 3Huifeng Bio Pharmaceutical 28HFGB 29 Provides Update on COS Application Status 6798 1Huifeng Bio Pharmaceutical 28HFGB 29 Provides Update on COS Application Status 6798 2Huifeng Bio Pharmaceutical 28HFGB 29 Provides Update on COS Application Status 6798 3Killer pulses help characterize special surfaces 4246 1Killer pulses help characterize special surfaces 4246 2
(Date:11/21/2008)...ective against Lennox-Gastaut syndrome , ...called Banzel (rufinamide) has been approved as a ...psy called Lennox-Gastaut syndrome, the U.S. Food ... approval was based on results of a four-month cli...ompared to patients who took a placebo, those who ...
(Date:11/21/2008)...re/ -- NursingCenter.com, the premier site,for on...d content, has been,updated to improve the intera.... Powered by Lippincott Williams & Wilkins (LW...reviewed continuing education activities and free,...ng nursing journals.,Lippincott Williams & Wi...
(Date:11/21/2008)...PRNewswire-FirstCall/ -- Today, prescription drugs...treating 88 percent of patients suffering chronic ...or a chronic condition account for 96 percent of a...l medical costs. A proprietary new pharmacy model...ons, Inc. (NYSE: MHS ) significantly reduces cri...
(Date:11/21/2008)... diseaseits cause remains a mysteryswept into Athe...itizens, soldiers and refugees of the war then rag...ith corpses, social order broke down. Over the nex...ns lost a third of its population. It lost the war... the end of the Golden Age of Greece. , The Pla...
Breaking Medicine News(10 mins):Health News:FDA Approves New Drug for Severe Epilepsy 2Health News:NursingCenter.com Launches New Features to Improve User Experience 2Health News:NursingCenter.com Launches New Features to Improve User Experience 3Health News:New Data: Advanced Pharmacy Model Significantly Reduces Gaps in Care for Patients with Chronic and Complex Conditions; Improves Clinical and Financial Outcomes 2Health News:New Data: Advanced Pharmacy Model Significantly Reduces Gaps in Care for Patients with Chronic and Complex Conditions; Improves Clinical and Financial Outcomes 3Health News:New Data: Advanced Pharmacy Model Significantly Reduces Gaps in Care for Patients with Chronic and Complex Conditions; Improves Clinical and Financial Outcomes 4Health News:New Data: Advanced Pharmacy Model Significantly Reduces Gaps in Care for Patients with Chronic and Complex Conditions; Improves Clinical and Financial Outcomes 5Health News:New Data: Advanced Pharmacy Model Significantly Reduces Gaps in Care for Patients with Chronic and Complex Conditions; Improves Clinical and Financial Outcomes 6Health News:Study of ancient and modern plagues finds common features 2Health News:Study of ancient and modern plagues finds common features 3Health News:Study of ancient and modern plagues finds common features 4
...atest study researchers have observed that doctors...ood pressure and other cardiac risk factors in eth...tal, Georgia have carried out a population survey ...igins, looking at their heart disease and stroke r...
...of a patient can have a major impact on how suscep...id arthritis, according to new research. The publi...to factors// not related to the disease when they ...oubt being diagnosed with a chronic, disabling dis...
... alfa treats anaemia in cancer patients and thereb...ry common side effect of cancer chemotherapy. It r... the protein that carries oxygen round the body. T...lming exhaustion that is not relieved by rest. Pat...
...rve that a new topical medication can effectively ...he sun. They found that in a long-term study of ta...nkling and mottled skin in more than 55 percent// ...how additional benefit as the length of use increa...
Other Medicine News:Health News:Personality Impacts Arthritis 2
...ormance Tecoflex stents that save inventory, shelf...eteral Stents accommodate ureteral lengths from 22...ws the Quadra-Coil to glide over any guidewire and...provide ease of placement and patient comfort in a...
...temporary internal drainage from the ureteropelvic...is engineered for ease of placement and patient co... designed for repositioning and ease of removal. A... that when activated, attracts and holds water and...
The CMV IgM enzyme immunoassay is for the qualitative detection of antibodies to cytomegalovirus. The CMV IgM assay is primarily indicated for the detection of early or recent infection.
The Shandon Sequenza uses the Shandon Coverplate system which ensures consistency and excellent staining quality. , , ,Allows the user to perform large immunostaining runs (up to 50 slides/run
Medicine Products: