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

Tracking Information

First Received Date ^ICMJE

March 6, 2003

Last Updated Date

September 13, 2005

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

lung function
respiratory symptoms
sputum weight
pulmonary exacerbations
measures of lung characteristics

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00056147 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

safety measures

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease

Brief Summary

The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).

Detailed Description

The purpose of this study is to:

assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease;
explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer;
identify dose(s) that will be studied in subsequent trials.

Study Phase

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)

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

June 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

confirmed diagnosis of CF
FEV1 greater than or equal to 75% of predicted normal for age, gender, and height
oxyhemoglobin saturation greater than or equal to 90%
clinically stable

Exclusion Criteria:

abnormal renal or liver function
clinically significant findings atypical for moderate cystic fibrosis

Gender

Both

Ages

8 Years to 50 Years

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

NCT00056147

Responsible Party

Study ID Numbers ^ICMJE

08-103

Study Sponsor ^ICMJE

Inspire Pharmaceuticals

Collaborators ^ICMJE

Cystic Fibrosis Foundation

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