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NCT00570349 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis
A Phase 1 study of Cystic Fibrosis, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00570349: Completed Phase 1 study of Cystic Fibrosis, sponsored by Mallinckrodt.
NCT00570349 is a Phase 1 study of Cystic Fibrosis that has completed, run by Mallinckrodt. The registered enrollment target is 18 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00570349, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expiratory volume in one second (FEV1), or an increase in methemoglobin.
Primary Outcome
Methemoglobin level assessments were measured through blood draws - hematology. This test measures the amount of methemoglobin (a type of hemoglobin that is unable to transport oxygen to tissues) in blood. Normal methemoglobin percentage range 1% - 2%.
Conditions Studied
Interventions
- DRUG Nitrogen
- DRUG Nitric Oxide for Inhalation
Study Locations (1)
Colorado
- The Children's Hospital - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-07 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
What the finished NCT00570349 record still lists
NCT00570349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Nitrogen is the first listed.
NCT00570349 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT00570349 about?
NCT00570349 is a clinical study titled "Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis". The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expirat...
What is the current status of trial NCT00570349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2004-07. Estimated completion is 2008-12.
What conditions does trial NCT00570349 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT00570349?
The interventions under investigation include: Nitrogen (DRUG), Nitric Oxide for Inhalation (DRUG).
Who is sponsoring clinical trial NCT00570349?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00570349 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00570349's enrollment target sits among peer trials
18 135th of 169 higher than 33 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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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