Trial · NCT02694393
Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
NCT02694393, Phase 1, Phase 2, Terminated, Schmidhofer, Mark, MD; results first posted 2024-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis. Trials, record NCT02694393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02694393
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
- NCT number
- NCT02694393
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Schmidhofer, Mark, MD
- Conditions
- Cystic Fibrosis
- Interventions
- sodium nitrite
- First posted
- 2016-02-29
- Last updated
- 2024-06-24
- Results first posted
- 2024-06-24
- Limitations and caveats
- The study was terminated early due to expiration of investigational product and lack of a manufacturer.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pulmonary Function | Day 7 | forced expiratory volume in one second (FEV1) after inhalation will assess safety |
| Primary | Pulmonary Function | Day 28 | forced expiratory volume in one second (FEV1) after inhalation will assess safety |
| Secondary | Exhaled Nitric Oxide | Day 7 | concentration of nitric oxide in exhaled breath |
| Secondary | Exhaled Nitric Oxide | Day 28 | concentration of nitric oxide in exhaled breath |
| Secondary | Sputum Nitrite Concentration | day 7 | concentration of nitrite in sputum |
| Secondary | Sputum Nitrite Concentration | day 28 | concentration of nitrite in sputum |
| Secondary | Pseudomonas Density in Sputum | day 28 | density of Pseudomonas in sputum |
| Secondary | CF Questionnaire - Respiratory | day 28 | respiratory symptom questionnaire |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pulmonary Function | Day 7 | percentage of predicted FEV1 | MEAN | |
| PRIMARY | Pulmonary Function | Day 28 | percentage of predicted FEV1 | NUMBER | |
| SECONDARY | Exhaled Nitric Oxide | Day 7 | parts per billion | MEAN | |
| SECONDARY | Exhaled Nitric Oxide | Day 28 | parts per billion | NUMBER | |
| SECONDARY | Sputum Nitrite Concentration | day 7 | Sputum nitrite data not collected/measured | ||
| SECONDARY | Sputum Nitrite Concentration | day 28 | Sputum nitrite data not collected/measured | ||
| SECONDARY | Pseudomonas Density in Sputum | day 28 | Pseudomonas density in sputum data not collected/measured | ||
| SECONDARY | CF Questionnaire - Respiratory | day 28 | respiratory symptom questionnaire data not collected/measured |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pulmonary Function | Nebulized Nitrite | 59 | Full Range 37 to 81 | percentage of predicted FEV1 | |
| Pulmonary Function | Nebulized Nitrite | 78 | percentage of predicted FEV1 | ||
| Exhaled Nitric Oxide | Nebulized Nitrite | 10 | Full Range 8 to 12 | parts per billion | |
| Exhaled Nitric Oxide | Nebulized Nitrite | 12 | parts per billion |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nebulized Nitrite | 2 | |
| Overall Study | COMPLETED | Nebulized Nitrite | 1 | |
| Overall Study | NOT COMPLETED | Nebulized Nitrite | 1 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Methemoglobinemia | Blood and lymphatic system disorders | Nebulized Nitrite | 0 | 2 | 0 |
| other | Hypotension | Cardiac disorders | Nebulized Nitrite | 1 | 2 | 1 |
| other | Decreased FEV1 | Respiratory, thoracic and mediastinal disorders | Nebulized Nitrite | 1 | 2 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nebulized Nitrite | 0 | 2 |
| Total, other adverse events | Nebulized Nitrite | 2 | 2 |
| Total, serious adverse events | Nebulized Nitrite | 0 | 2 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02694393
GET https://conductscience.org/api/trials/v1/NCT02694393/registered