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

[Guest guest]

The link in your post pretty much sums it up; I may be able to find another

and send it--n

A New CF Treatment - INS37217 - Sounds very

Hopeful!!!

>

>

>

> 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@m... .

>

> 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@i...

>

>

> 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@a...

> 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/

>

>

>

>

>

>

>

[Guest guest]

A New CF Treatment - INS37217 - Sounds very

Hopeful!!!

>

>

>

> 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@m... .

>

> 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@i...

>

>

> 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@a...

> 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/

>

>

>

>

>

>

>