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A Study in Adult and Pediatric Patients With Cystic Fibrosis

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: April 29, 2002
Last updated: February 13, 2015
Last verified: February 2015
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • assess safety and tolerability

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

Enrollment: 63
Study Start Date: June 2001
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00034515

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Amy Schaberg, BSN
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00034515     History of Changes
Other Study ID Numbers: 08-102
Study First Received: April 29, 2002
Last Updated: February 13, 2015

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on September 21, 2017