A Study in Adult and Pediatric Patients With Cystic Fibrosis

Merck Sharp & Dohme LLC63 enrolled

Overview

The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium (INS37217) Inhalation SolutionDRUG

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * FEV1 40-70% (adults) * FEV1 \>/=50% (pediatrics) * oxygen saturation \>90% * clinically stable * willing to stay overnight Exclusion Criteria: * abnormal renal or liver function * receiving corticosteroids exceeding 10mg/day or 20 mg every other day * received intravenous or aerosolized antibiotics 1 week prior to dosing

Outcomes

Primary Outcomes

assess safety and tolerability

Secondary Outcomes

assess effects of INS37217 on sputum weight and symptoms

Data from ClinicalTrials.gov

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