Cystic Fibrosis
Conditions
Brief 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.
Interventions
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.
DRUGPlacebo - 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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lung function | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary exacerbation | 48 weeks |
| Requirements for concomitant CF medications | 48 weeks |
| Quality of Life | 48 weeks |
Outcome results
None listed