Interstitial Lung DiseasePhase 2NCT01381666
Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)
A Phase 2 study testing INS316 solution for inhalation and hypertonic saline 3% sodium chloride solution in people with Interstitial Lung Disease, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- INS316 solution for inhalation and hypertonic saline 3% sodium chloride solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 years or older
- undergone diagnostic bronchoalveolar lavage within the previous 21 days
- diagnosed with sarcoidosis or other ILD
Who cannot join
- having resting hypoxemia
- receiving corticosteroid treatment
About this study
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.
- Conditions
- Interstitial Lung Disease
- Being tested
- INS316 solution for inhalation, hypertonic saline 3% sodium chloride solution
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS316 solution for inhalationDrug
inhalation via nebulizer given for 2 doses for 60 minutes each
hypertonic saline 3% sodium chloride solutionDrug
inhalation via nebulizer given for 2 doses for 60 minutes each
| Study group | Role | What they receive |
|---|---|---|
| INS316 | Experimental | inhalation via nebulizer given for 2 doses for 60 minutes each Receives: Drug: INS316 solution for inhalation |
| hypertonic saline 3% sodium chloride solution | Placebo comparator | inhalation via nebulizer given for 2 doses for 60 minutes each Receives: Drug: hypertonic saline 3% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of sarcoidosis using sputum induction (sputum weight)
Measured: 60 minutes
Secondary outcomes (1)
adverse events
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2003
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381666
- Sponsor's protocol ID
- 01-701
- Status last verified
- Oct 2015
- First submitted
- 23 Jun 2011
- Last updated
- 29 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)
- ClinicalTrials.gov ID
- NCT01381666
- Acronym / sponsor ID
- 01-701
- Conditions
- Interstitial Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INS316 | Experimental | Drug: INS316 solution for inhalationinhalation via nebulizer given for 2 doses for 60 minutes each |
| hypertonic saline 3% sodium chloride solution | Placebo comparator | Drug: hypertonic saline 3% sodium chloride solutioninhalation via nebulizer given for 2 doses for 60 minutes each |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18 years or older
- undergone diagnostic bronchoalveolar lavage within the previous 21 days
- diagnosed with sarcoidosis or other ILD
Key exclusion criteria (2 listed)
- having resting hypoxemia
- receiving corticosteroid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INS316 solution for inhalationinhalation via nebulizer given for 2 doses for 60 minutes each | Drug | INS316 |
| hypertonic saline 3% sodium chloride solutioninhalation via nebulizer given for 2 doses for 60 minutes each | Drug | hypertonic saline 3% sodium chloride solution |
Primary outcome
diagnosis of sarcoidosis using sputum induction (sputum weight)
Time frame: 60 minutes
1 secondary outcome
adverse events
Time frame: 60 minutes
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INS316 solution for inhalation and hypertonic saline 3% sodium chloride solution in people with Interstitial Lung Disease, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of sarcoidosis using sputum induction (sputum weight) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.