A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

Completed · Phase 2

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).

Key facts

Study ID

NCT00130182

Run by

Merck Sharp & Dohme LLC

People needed

13

Starts

2005-08-01

Last updated by the study team

2013-05-22

Who can join

Age: 5 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have confirmed diagnosis of CF
• Have an FEV1 greater than or equal to 60%
• Have oxygen saturation greater than or equal to 90% on room air
• Be clinically stable for at least 4 weeks prior to screening
• Be able to reproducibly perform spirometry maneuvers

You may not qualify if…

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

Where it is running

• The Children's Hospital — Denver, Colorado, United States
• General Clinic Research Center University of Minnesota — Minneapolis, Minnesota, United States
• The Minnesota CF Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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