Evaluation of the Diagnostic Utility of INS316 in Patient... | NCT01381666

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

NCT01381666

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Oct 29, 2015Estimated

Enrollment

22Actual

Phase

Phase 2

Conditions

Interstitial Lung Disease

Interventions

INS316 solution for inhalation
hypertonic saline 3% sodium chloride solution

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Apr 2004Actual

Completion Date

Apr 2004Actual

First Submitted Date

Jun 23, 2011

First Submission Date that Met QC Criteria

Jun 24, 2011

First Posted Date

Jun 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 24, 2011

Certification/Extension First Submitted that Passed QC Review

Jun 24, 2011

Certification/Extension First Posted Date

Jun 27, 2011Estimated

Last Update Submitted Date

Oct 7, 2015

Last Update Posted Date

Oct 29, 2015Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INS316	Experimental	inhalation via nebulizer given for 2 doses for 60 minutes each	Drug: INS316 solution for inhalation
hypertonic saline 3% sodium chloride solution	Placebo Comparator	inhalation via nebulizer given for 2 doses for 60 minutes each	Drug: hypertonic saline 3% sodium chloride solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INS316 solution for inhalation	Drug	inhalation via nebulizer given for 2 doses for 60 minutes each	INS316

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
adverse events		60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001239	Inhalation
D012462	Saline Solution, Hypertonic
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D015656	Respiratory Mechanics
D012119	Respiration
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided