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A Study in Adult and Pediatric Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00034515
First received: April 29, 2002
Last updated: September 13, 2005
Last verified: September 2005
History of Changes
  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 Intervention Phase
Cystic Fibrosis
 Drug: denufosol tetrasodium (INS37217) Inhalation Solution
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 Patients

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • assess safety and tolerability

Secondary Outcome Measures:
  • assess effects of INS37217 on sputum weight and symptoms

Estimated Enrollment: 72
Study Start Date: June 2001
Estimated Study Completion Date: October 2002
  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • abnormal renal or liver function
  • receiving corticosteroids exceeding 10mg/day or 20 mg every other day
  • received intravenous or aerosolized antibiotics 1 week prior to dosing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034515

Locations
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Minnesota
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Merck
Investigators
Study Director: Amy Schaberg, BSN
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00034515     History of Changes
Other Study ID Numbers: 08-102
Study First Received: April 29, 2002
Last Updated: September 13, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013