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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357279
• Other study ID #: 08-108
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2006
• Last updated: October 9, 2015
• Start date: July 2006
• Est. completion date: September 2008

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Diseases
• Pulmonary Fibrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lung function		48 weeks	Yes
Secondary	Pulmonary exacerbation		48 weeks	Yes
Secondary	Requirements for concomitant CF medications		48 weeks	No
Secondary	Quality of Life		48 weeks	No