Navigation Links
Inspire's Phase 3 CF Trial, Using PARI's Nebulizer & Compressor, Shows Positive Top-Line Results
Date:6/12/2008

MIDLOTHIAN, Va., June 12 /PRNewswire/ -- On Friday, Inspire Pharmaceuticals (Nasdaq: ISPH) announced positive top-line results of the first Phase 3 trial with denufosol tetrasodium inhalation solution delivered via PARI's LC STAR nebulizer and PRONEB Ultra compressor for the treatment of cystic fibrosis (CF).

"We are pleased to see these positive top-line results and hope that Inspire's denufosol tetrasodium inhalation solution delivered via PARI's LC STAR and PRONEB Ultra compressor will become the first early intervention therapy available to CF patients," said Lisa Cambridge, director of Clinical Development at PARI Respiratory Equipment.

The trial demonstrated statistical significance for its primary efficacy endpoint, which was the change in FEV1 (Forced Expiratory Volume in One Second) from baseline at the trial endpoint (at 24 weeks or last observation carried forward). Patients treated with denufosol had a statistically significant improvement in FEV1 compared to placebo (45 milliliter treatment group difference, p = 0.047). On average, patients on denufosol improved relative to baseline whereas patients on placebo remained essentially unchanged.

The results were reported from the 24-week placebo-controlled portion of the 352-patient Phase 3 trial (TIGER-1) with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis. Additional information is available at http://www.inspirepharm.com.

The combination of PARI's LC STAR breath-enhanced nebulizer and PRONEB Ultra compressor provides for a quick treatment with high efficiency and minimal medication waste.

Denufosol for the treatment of cystic fibrosis has been granted Fast Track designation and orphan drug status in the United States by the FDA and orphan drug designation in Europe by the European Medicines Agency (EMEA).

About PARI Respiratory Equipment, Inc.

PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis. PARI's worldwide vision is to improve the lives of those affected by respiratory diseases and those who care for them.

Maker of the world's leading breath-enhanced reusable nebulizer, the PARI LC PLUS, and the new PARI LC Sprint nebulizer line, PARI also manufactures the award-winning PARI TREK S compact compressor, Bubbles the Fish II aerosol mask, and durable PARI PRONEB Ultra II. PARI's Vortex anti-static valved holding chamber improves the aerosol deposition of metered dose inhalers (MDI's). PARI's North American headquarters is in Midlothian, VA with worldwide headquarters in Starnberg, Germany. Online at http://www.Pari.com

Additional information is available by contacting Ayars & Associates at 805-845-5682 or Ashley Weigand at 804-253-7274 x711.


'/>"/>
SOURCE PARI Respiratory Equipment, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Positive Phase I/II Data of IDX899 Confirm Potent Antiviral Activity and Favorable Safety Profile in Treatment-Naive HIV-Infected Patients
2. Arena Pharmaceuticals Presented Positive Phase 2a Clinical Trial Results of APD125 for the Treatment of Insomnia at 22nd Annual Meeting of the Associated Professional Sleep Societies
3. ChemoCentryx Completes Enrollment of PROTECT-1, a Phase II/III Clinical Trial of CCR9 Antagonist CCX282-B (Traficet-EN(TM)) in Crohns Disease
4. Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder
5. Micromet and MedImmune Commence Treatment in Phase 2 Trial of BiTE Antibody Blinatumomab (MT103/MEDI-538) in Patients with Acute Lymphoblastic Leukemia
6. Vical Receives $6.3 Million Payment for Continued Funding of Allovectin-7(R) Phase 3 Trial
7. Targeted Genetics Announces Positive Phase 1/2 tgAAC94 Data Presented at Annual European Congress of Rheumatology
8. Iomai Announces Publication in The Lancet of Phase II Study Demonstrating Significant Efficacy of Travelers Diarrhea Vaccine
9. Morria Biopharmaceuticals Plc Announces Regulatory Approval to Commence Phase II Clinical Study of MRX-4 in Allergic Rhinitis
10. CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Melanoma
11. Data From Two Phase 3 Studies Show Anti-TNF Golimumab Significantly Improved Signs and Symptoms of Rheumatoid Arthritis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... , May 24, 2016 ... beide primären Endpunkte und demonstriert ... in ‚ausgezeichneter plus guter , ...    ,      (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a ... heute neue positive Daten von der MORA-Studie der ...
(Date:5/24/2016)... New Zealand , May 24, 2016 ... and informatics solutions for the healthcare sector, has been named ... New Zealand Hi-Tech Awards 2016. Dr Bruce ... fantastic acknowledgement for our team.  It,s really good to be ... burden healthcare internationally. Our products are used in 35 countries ...
(Date:5/24/2016)... May 24, 2016  Joe Marziani has joined VMS BioMarketing as senior vice president ... today. In his new role, Marziani will lead the company,s business development and sales ... improve outcomes. Photo - http://photos.prnewswire.com/prnh/20160523/371089 ... ... ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... , ... On Memorial Day, Hope For Heroes and USA Medical ... for the country. The nonprofit Hope For Heroes partnered with the leading provider ... for disabled military veterans, as well as police, firemen, and EMS professionals across the ...
(Date:5/26/2016)... ... May 26, 2016 , ... Cardiac arrhythmia is ... impact on long-term patient survival, reports a team of UPMC researchers in the ... in the Journal of Thoracic and Cardiovascular Surgery, provide critical information that will ...
(Date:5/26/2016)... Hampshire (PRWEB) , ... May 26, 2016 , ... MadgeTech ... are designed, engineered, and manufactured in Warner, New Hampshire at the MadgeTech headquarters. With ... provide reliable monitoring solutions trusted by government agencies, including NASA. , In 2012, ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James Maisel will ... Long Island Chapter on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public ... Retina Group of New York , is a Board Certified ophthalmologist who ...
(Date:5/26/2016)... ... 26, 2016 , ... In an effort to provide hair restoration information to the widest possible ... those who do not use the app. Dr. Mohebi, the founder of Parsa Mohebi Hair ... Live . , Dr. Mohebi says, “The positive response to the Snapchat videos we ...
Breaking Medicine News(10 mins):