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NCT01381666 Clinical Trial

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

Interstitial Lung Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01381666
Other study ID # 01-701
Secondary ID
Status Terminated
Phase Phase 2
First received June 23, 2011
Last updated October 7, 2015
Start date January 2003
Est. completion date April 2004

Study information
Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 22
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Drug:
• INS316 solution for inhalation
inhalation via nebulizer given for 2 doses for 60 minutes each
• hypertonic saline 3% sodium chloride solution
inhalation via nebulizer given for 2 doses for 60 minutes each

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary diagnosis of sarcoidosis using sputum induction (sputum weight) 60 minutes No
Secondary adverse events 60 minutes No
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