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NCT01315236 · ClinicalTrials.gov registry record · Phase 2
Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
A Phase 2 study, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT01315236: Completed Phase 2 study, sponsored by Insmed Incorporated.
NCT01315236 is a Phase 2 study that has completed, run by Insmed Incorporated. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01315236, a Phase 2 study, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease. The first part of the study is the 84-day double-blind phase to evaluate the primary and secondary endpoints.
Primary Outcome
The endpoint used the 7-step semi-quantitative scale (SQS) for mycobacterial culture reporting in both solid and liquid growth media, with step 1 = culture negative in both solid and liquid media, step 2 = growth in liquid medium only, 3 = solid medium positive, 4 = 50 to 100 colonies in solid medium \& growth in liquid, 5 = \>100 to 200 colonies in solid medium \& growth in liquid, 6 = \>200 to 500 colonies in solid medium \& growth in liquid, 7 = \>500 colonies in solid medium \& growth in liq
Interventions
- DRUG placebo
- DRUG Liposomal amikacin for inhalation (LAI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2012-04-19 |
| Est. Completion | 2015-06-18 |
| Phase | Phase 2 |
What the finished NCT01315236 record still lists
NCT01315236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01315236 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01315236 about?
NCT01315236 is a clinical study titled "Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria". The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease. The first part of the study is the 84-day double-blind phase to evaluate the primary and secondary endpoi...
What is the current status of trial NCT01315236?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2012-04-19. Estimated completion is 2015-06-18.
What interventions are being tested in trial NCT01315236?
The interventions under investigation include: placebo (DRUG), Liposomal amikacin for inhalation (LAI) (DRUG).
Who is sponsoring clinical trial NCT01315236?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01315236's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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