Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00625612

08-110

P08640

Details and patient eligibility

About

The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

Enrollment: 466 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have confirmed diagnosis of cystic fibrosis
• Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
• Be able to reproducibly perform spirometry
• Be clinically stable for at least 4 weeks before screening

Exclusion criteria

• Have abnormal renal or liver function
• Have lung transplant
• Unable to discontinue use of hypertonic saline
• Participated in Inspire trial 08-108

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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466 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Treatment:

Drug: Placebo

1

Experimental group

Description:

Denufosol Tetrasodium (INS37217) Inhalation Solution

Treatment:

Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution