A Study in Adult and Pediatric Patients With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2002-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

NCT00056147

Cystic Fibrosis

COMPLETED PHASE2

Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

NCT00103714

Cystic Fibrosis

COMPLETED PHASE2

Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

NCT00425165

Cystic Fibrosis

TERMINATED PHASE2

A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

NCT00130182

Cystic Fibrosis

COMPLETED PHASE2

Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

NCT00625612

Cystic Fibrosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

denufosol tetrasodium (INS37217) Inhalation Solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No