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

January 28, 2015 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
safety measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Cystic Fibrosis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

March 6, 2003

First Submitted That Met QC Criteria

March 6, 2003

First Posted (Estimate)

March 7, 2003

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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