Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Cystic Fibrosis

Treatments

Drug: denufosol tetrasodium (INS37217)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00103714

08-104

Details and patient eligibility

About

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.

Enrollment

72 patients

Sex

All

Ages

8 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have confirmed diagnosis of CF
Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
Have oxygen saturation greater than or equal to 90% on room air
Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
Be able to reproducibly perform spirometry maneuvers

Exclusion criteria

Have changed their physiotherapy technique or schedule within 7 days prior to screening
Have clinically significant comorbidities
Using prior and concurrent medications according to the protocol