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:7/14/2017)... -- Endo International plc (NASDAQ: ENDP ) will announce ... of its senior management team will host a conference call and ... The dial-in number to access the call is ... the passcode is 45397076. Please dial in 10 minutes prior to ... A replay of the call will be available from August 8, ...
(Date:7/13/2017)... 13, 2017  New York City-based market research firm Kalorama ... be aware of.  From new products to new costs, to ... a recently completed study, Potential Pipeline Disruptors . ... 1.  Age-Driven Growth - True Impact Moment ... of the impact the growing population and, to a more ...
(Date:7/11/2017)... WHIPPANY, N.J. , July 11, 2017  Bayer has ... across eight countries as part of its prestigious Bayer Hemophilia ... Children,s Hospital of Philadelphia and Uniformed ... are among the winners. Grant recipients were announced ... Thrombosis and Hemostasis (ISTH) 2017 Congress, Berlin, Germany ...
Breaking Medicine Technology:
(Date:7/21/2017)... ... July 21, 2017 , ... Hospital M&A activity slowed in the ... number of hospital acquisitions rose to 23 in the second quarter, up 15% from ... from the 20 announced deals in the year-ago second quarter. Only four of the ...
(Date:7/21/2017)... ... July 21, 2017 , ... ... a $5,000 grant from the C. R. Bard Foundation, Inc. to ... Somerset Hills , a service available through the nonprofit home care agency. Using ...
(Date:7/21/2017)... ... July 21, 2017 , ... West Dermatology is pleased to ... PA-C. Beginning July 17, 2017, Ms. Vu will join West Dermatology’s large network of ... in dermatology, skin cancer , and more. She graduated from the University of ...
(Date:7/20/2017)... ... July 20, 2017 , ... TransPixel Volume 2 is a set of transitions ... timeline. This effect isolates horizontal and vertical lines of pixels and sorts their pixels ... or flipping animation and can be changed using a drop-down menu. Create amazing and ...
(Date:7/20/2017)... Houston, Texas (PRWEB) , ... July 20, 2017 ... ... and litigation law firm headquartered in Houston, is pleased to announce their expansion ... decades of affordable housing experience, directors Alysse Hollis and Ronald Bell, and of ...
Breaking Medicine News(10 mins):