Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)

October 7, 2015 updated by: Merck Sharp & Dohme LLC
The objective of the present work is to explore and compare the diagnostic quality of sputum specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316 in patients diagnosed with interstitial lung diseases.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 18 years or older
  • undergone diagnostic bronchoalveolar lavage within the previous 21 days
  • diagnosed with sarcoidosis or other ILD

Exclusion Criteria:

  • having resting hypoxemia
  • receiving corticosteroid treatment

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INS316
inhalation via nebulizer given for 2 doses for 60 minutes each
Drug: INS316 solution for inhalation
inhalation via nebulizer given for 2 doses for 60 minutes each
Placebo Comparator: hypertonic saline 3% sodium chloride solution
inhalation via nebulizer given for 2 doses for 60 minutes each
Drug: hypertonic saline 3% sodium chloride solution
inhalation via nebulizer given for 2 doses for 60 minutes each

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
diagnosis of sarcoidosis using sputum induction (sputum weight)
Time Frame: 60 minutes
60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

January 1, 2003

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-701

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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