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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01381666

Enrollment

Registered

2011-06-27

Start date

2003-01-31

Completion date

2004-04-30

Last updated

2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

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.

Interventions

DRUGINS316 solution for inhalation

inhalation via nebulizer given for 2 doses for 60 minutes each

DRUGhypertonic saline 3% sodium chloride solution

inhalation via nebulizer given for 2 doses for 60 minutes each

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
adverse events	60 minutes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026