A Study in Adult and Pediatric Patients With Cystic Fibrosis

Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00034515

Enrollment

Registered

2002-04-30

Start date

2001-06-30

Completion date

2002-08-31

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

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

Interventions

DRUGdenufosol tetrasodium (INS37217) Inhalation Solution

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

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

Design outcomes

Primary

Measure	Time frame
assess safety and tolerability	—

Secondary

Measure	Time frame
assess effects of INS37217 on sputum weight and symptoms	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026