A New CF Treatment - INS37217 - Sounds very Hopeful!!!

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There is a new study for a future CF treatment. This can be found at the UNC

CF Site http://www.clinicaltrials.gov/ct/show/NCT00056147?order=1

Its called the INS37217 study.     A Phase 1b/2a Ascending Dose Cohort Study

to Assess the safety, tolerability, and effects of five dose levels of

INS37217 and placebo followed by five days twice daily treatment with maximum

tolerated dose administered by inhalation via the Pari LC Star nebulizer in

adult and

pediatric patients with cystic fibrosis.

Sponsor: Inspire Pharmaceuticals, Inc. PI: Peadar Noone, MD. This study will

look at the safety, tolerability and effects of the drug INS37217, thought to

improve mucociliary clearance by improving ciliary beat frequency and

increasing hydration. CF patients >5 years of age with stable disease may be

included.

Contact: Minnix, RN sminnix@... . 

Information behind it: They recently discovered " WHY CPT AND EXERCISE "

helps CF so much. We have a hormone in our lungs that does not work, its the

hormone we need to clear mucus/draw fluids/chloride into our lungs. Usually this

does not work in CF, but when we excercise/do CPT the back up hormone works.

Which clears the sticky, dry mucus. This medication is believed to make that

horomone work, which will result in regular mucus clearance, no bactieral lung

infection, no more lung damage. and if things go as hoped it will be on the

market in 4 years. This will make the CF lungs, work like a healthy persons

lungs.

The faster these studies are done the faster we get new medicines. Dr.

Boucher, says this should make CF lungs like normal lungs!!! Wow!!

Here is the info from the web site and participating centers in this study...

Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis

Lung Disease

This study is currently recruiting patients.

Sponsored by

Inspire Pharmaceuticals

Cystic Fibrosis Foundation Therapeutics

Purpose

The purpose of this study is to assess the safety and effectiveness of

multiple dosages of INS37217 compared to placebo over 28 days in subjects with

mild

to moderate cystic fibrosis (CF) lung disease. Study drug will be administered

through a nebulizer (a device that delivers medication as a mist by breathing

it in).

Condition Treatment or InterventionPhase

Cystic Fibrosis

Drug: INS37217

Phase II

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel

Assignment, Safety/Efficacy Study

Official Title: Multi-Center, Double-Blind, Randomized, Placebo-Controlled,

28-Day Study of INS37217 Inhalation Solution in Subjects with Mild to Moderate

Cystic Fibrosis Lung Disease

Further Study Details:

The purpose of this study is to:

assess the safety and efficacy of multiple dose levels of INS37217 compared

to placebo over 28 days in subjects with mild to moderate CF lung disease;

explore evidence of activity of INS37217 and placebo administered via PARI LC

STAR

nebulizer; identify dose(s) that will be studied in subsequent trials.

Eligibility

Ages Eligible for Study: 8 Years - 50 Years,

Genders Eligible for Study: Both

Criteria: confirmed diagnosis of CF

FEV1 greater than or equal to 75% of predicted normal

oxyhemoglobin saturation greater than or equal to 90%

clinically stable

Expected Total Enrollment: 92

Location and Contact Information

Dave Mathews dmathews@...

California

Stanford University Hospital and Clinics, Palo Alto, California,

94305, United States; Recruiting

Colorado

The Children's Hospital, Denver, Colorado, 80218, United States;

Recruiting

Illinois

Children's Memorial Hospital, Chicago, Illinois, 60614, United

States; Recruiting

land

The s Hopkins Hospital, Baltimore, land, 21287, United

States; Recruiting

Massachusetts

Massachusetts General Hospital, Boston, Massachusetts, 02114, United

States; Recruiting

Children's Hospital, Boston, Massachusetts, 02115, United States;

Recruiting

Minnesota

University of Minnesota General Clinical Research Center, Minneapolis,

Minnesota, 55455, United States; Recruiting

Fairview University Medical Center, Minneapolis, Minnesota, 55455,

United States; Recruiting

Missouri

Cardinal Glennon Children's Hospital, St. Louis, Missouri, 63104,

United States; Recruiting

North Carolina

University of North Carolina - Chapel Hill, Chapel Hill, North

Carolina, 27514, United States; Recruiting

Ohio

Cincinnati's Children's Hospital Medical Center, Cincinnati, Ohio,

45229-3039, United States; Recruiting

Columbus Children's Hospital, Columbus, Ohio, 43205, United States;

Recruiting

Tennessee

Vanderbilt University Medical Center, Nashville, Tennessee, 37232,

United States; Recruiting

Texas

Texas Children's Hospital, Houston, Texas, 77030, United States;

Recruiting

Washington

Children's Hospital and Regional Medical Center, Seattle, Washington,

98105, United States; Recruiting

University of Washington Medical Center, Seattle, Washington, 98195,

United States; Recruiting

More Information

Joanne

Joanne M. Schum

Cystic Fibrosis

Bi-lateral Lung Transplant Recipient

September 12, 1997

University of North Carolina Hospitals Chapel Hill

Residence: Upstate New York

email: luckylungsforjo@...

Manager of: Transplant Support - Lung, Heart/Lung, Heart

http://groups.msn.com/TransplantSupportLungHeartLungHeart

" Taking Flight - Inspirational Stories of Lung Transplantation "

Compiled by Joanne Schum

Authored by lung recipients around the world

http://www.trafford.com/robots/02-0497.html

http://www.trafford.com/