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Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00357279
First received: July 25, 2006
Last updated: March 30, 2011
Last verified: June 2008
History of Changes
  Purpose

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.


Condition Intervention Phase
Cystic Fibrosis
 Drug: denufosol tetrasodium (INS37217) Inhalation Solution
Drug: Placebo - 0.9% w/v sodium chloride solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

Resource links provided by NLM:

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

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in lung function [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pulmonary exacerbation [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Requirements for concomitant CF medications [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: July 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Placebo - 0.9% w/v sodium chloride solution
4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.
Experimental: 2 Drug: denufosol tetrasodium (INS37217) Inhalation Solution
Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.

  Eligibility

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

Inclusion Criteria:

  • Have confirmed diagnosis of cystic fibrosis
  • Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and height
  • Be able to reproducibly perform spirometry maneuvers
  • Be clinically stable for at least 4 weeks prior to screening

Exclusion Criteria:

  • Have abnormal renal or liver function
  • Have chest x-ray at screening suggesting clinically significant active pulmonary disease
  • Be colonized with Burkholderia cepacia
  • Have had a lung transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357279

  Show 81 Study Locations
Sponsors and Collaborators
Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amy Schaberg, RN, BSN Vice President Respiratory Clinical Research, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00357279     History of Changes
Other Study ID Numbers: 08-108
Study First Received: July 25, 2006
Last Updated: March 30, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 13, 2013