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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Interstitial Lung Disease

Treatments: Drug: INS316 solution for inhalation; Drug: hypertonic saline 3% sodium chloride solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01381666

01-701

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

22 participants in 2 patient groups, including a placebo group

INS316

Experimental group

Description:

inhalation via nebulizer given for 2 doses for 60 minutes each

Treatment:

Drug: INS316 solution for inhalation

hypertonic saline 3% sodium chloride solution

Placebo Comparator group

Description:

inhalation via nebulizer given for 2 doses for 60 minutes each

Treatment:

Drug: hypertonic saline 3% sodium chloride solution