NCT01381666

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

June 23, 2011

Last Update Submit

October 7, 2015

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • diagnosis of sarcoidosis using sputum induction (sputum weight)

    60 minutes

Secondary Outcomes (1)

  • adverse events

    60 minutes

Study Arms (2)

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

INS316 solution for inhalationDRUG

inhalation via nebulizer given for 2 doses for 60 minutes each

INS316
hypertonic saline 3% sodium chloride solutionDRUG

inhalation via nebulizer given for 2 doses for 60 minutes each

hypertonic saline 3% sodium chloride solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • having resting hypoxemia
  • receiving corticosteroid treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

InhalationSaline Solution, HypertonicSodium Chloride

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaHypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

January 1, 2003

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

October 29, 2015

Record last verified: 2015-10