Clinical Trial: 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients


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8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients

This study has been completed.

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals

Purpose

The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple 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

Condition	Treatment or Intervention	Phase
Cystic Fibrosis	Drug: INS37217	Phase I Phase II

MedlinePlus related topics: Cystic Fibrosis
Genetics Home Reference related topics: cystic fibrosis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Ph 1b/2a study to assess levels of INS37217 and placebo treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric CF pts

Further Study Details:

Study start: June 2001; Study completion: October 2002

Eligibility

Ages Eligible for Study: 5 Years and above, Genders Eligible for Study: Both

Criteria

FEV1 40-70% (adults), FEV1 >/=50% (pediatrics), oxygen saturation >90%, clinically stable, willing to stay overnight

Location Information

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

Maryland
The Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States

Minnesota
University of Minnesota Medical School, Minneapolis, Minnesota, 55455, United States

North Carolina
University of North Carolina Chapel Hill, Chapel Hill, North Carolina, 27514, United States

Ohio
Children's Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States

Rainbow Babies and Children's Hospital, Cleveland, Ohio, 44106, United States

Utah
University of Utah, Salt Lake City, Utah, 84132, United States

Washington
Children's Hospital and Regional Medical Center, Seattle, Washington, 98105, United States

More Information

Study ID Numbers: 08-102
Record last reviewed: August 2002
Record first received: April 29, 2002
ClinicalTrials.gov Identifier: NCT00034515
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20

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