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

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ClinicalTrials.gov Identifier: NCT01381666
Recruitment Status : Terminated
First Posted : June 27, 2011
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date : January 2003
Primary Completion Date : April 2004
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. diagnosis of sarcoidosis using sputum induction (sputum weight) [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 60 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01381666     History of Changes
Other Study ID Numbers: 01-701
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015

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