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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01381666
First received: June 23, 2011
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Interstitial Lung Disease
Drug: INS316 solution for inhalation
Drug: hypertonic saline 3% sodium chloride solution
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • diagnosis of sarcoidosis using sputum induction (sputum weight) [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2003
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INS316
inhalation via nebulizer given for 2 doses for 60 minutes each
Drug: INS316 solution for inhalation
inhalation via nebulizer given for 2 doses for 60 minutes each
Placebo Comparator: hypertonic saline 3% sodium chloride solution
inhalation via nebulizer given for 2 doses for 60 minutes each
Drug: hypertonic saline 3% sodium chloride solution
inhalation via nebulizer given for 2 doses for 60 minutes each

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381666

Locations
Israel
Tel-Aviv Medical Center
Tel-Aviv, Israel, 64239
Edith Wolfson Medical Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01381666     History of Changes
Other Study ID Numbers: 01-701
Study First Received: June 23, 2011
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014