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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014