A Study in Adult and Pediatric Patients With Cystic Fibrosis - Tabular View

Tracking Information

First Received Date ^ICMJE

April 29, 2002

Last Updated Date

September 13, 2005

Start Date ^ICMJE

June 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

assess safety and tolerability

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00034515 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

assess effects of INS37217 on sputum weight and symptoms

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study in Adult and Pediatric Patients With Cystic Fibrosis

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: denufosol tetrasodium (INS37217) Inhalation Solution

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00034515

Responsible Party

Study ID Numbers ^ICMJE

08-102

Study Sponsor ^ICMJE

Inspire Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amy Schaberg, BSN

Unaffiliated

Information Provided By

Inspire Pharmaceuticals

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP