Comparison · NCT01315236-d495b665
LAI 590 mg QD vs Placebo: Number of Participants Requiring Rescue Anti-mycobacterial or Other Rescue Drugs During the 84-day Double-blind Phase
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. LAI 590 mg QD vs Placebo: Number of Participants Requiring Rescue Anti-mycobacterial or Other Rescue Drugs During the 84-day Double-blind Phase. Trial comparisons, record NCT01315236-d495b665. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01315236-d495b665
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.477 | 0.338 | 0.621 | wilson | |
| Risk in group 2 | 0.244 | 0.142 | 0.387 | wilson | |
| Risk difference, group 1 minus group 2 | 0.233 | 0.0334 | 0.409 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.95 | 1.07 | 3.56 | log | |
| Odds ratio, group 1 over group 2 | 2.82 | 1.15 | 6.95 | log | |
| Number needed to treat, for one more participant with the outcome on LAI 590 mg QD than on Placebo | 4.3 | 2.45 | 29.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | LAI 590 mg QD | LAI 590 mg QD~Liposomal amikacin for inhalation (LAI): - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~* 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~* Administration time is approximately 13 minutes.~* Liposomal amikacin for inhalation will be administered for 84 days in the double-blind, randomized portion of the study.~* Subjects can continue with 84 additional days of dosing in the open label extension. | 21 | 44 | OG000 |
| Group 2 | Placebo | placebo QD~placebo: - Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.~* Administration procedures, volume and administration time are similar to LAI.~* Placebo will be administered for 84 days only during the double-blind, randomized portion of the study. | 11 | 45 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Requiring Rescue Anti-mycobacterial or Other Rescue Drugs During the 84-day Double-blind Phase
- Description
Per the study protocol, study subjects were on a stable, multi-drug, anti-mycobacterial regimen based on the 2007 ATS/IDSA Guidelines; the regimen should not have changed during the study period except for safety concerns. The need for changes to the concurrent anti-mycobacterial regimen or rescue therapy was at the discretion of the Investigator and was tracked as a study outcome.
- Time frame
- 84 days double-blind phase
- Population
- mITT
Source ClinicalTrials.gov
Trial
- Title
- Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
- NCT number
- NCT01315236
- Phases
- PHASE2
- Conditions
- Mycobacterium Infections, Nontuberculous
- Interventions
- Liposomal amikacin for inhalation (LAI), placebo
- Lead sponsor
- Insmed Incorporated
- Results first posted
- 2019-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01315236?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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