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Sponsored by: |
INO Therapeutics |
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Information provided by: | INO Therapeutics |
ClinicalTrials.gov Identifier: | NCT00570349 |
The primary objective of the trial is to assess the safety and tolerability of inhaled NO when administered by nasal cannula over a 44 hour period to clinically stable CF subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in FEV1, or an increase in methemoglobin.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Drug: Nitric Oxide for Inhalation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis |
Estimated Enrollment: | 18 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Low Dose Cohort: Experimental
Subjects will be enrolled sequentially into one of 2 cohorts of 9 patients each in a 2:1 fashion (active drug:placebo): initially a low-dose NO cohort (6 active: 3 placebo) followed by a high-dose NO cohort (6 active: 3 placebo)
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Drug: Nitric Oxide for Inhalation
NO or nitrogen will be administered via nasal cannula over a 44 hour period
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High-Dose Cohort: Experimental
Subjects will be enrolled sequentially into one of 2 cohorts of 9 patients each in a 2:1 fashion (active drug:placebo): initially a low-dose NO cohort (6 active: 3 placebo) followed by a high-dose NO cohort (6 active: 3 placebo)
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Drug: Nitric Oxide for Inhalation
The NO or nitrogen will be administered via nasal cannula over a 44 hours period.
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This trial will be a randomized, double-blind, placebo-controlled dose-escalating design. Following enrollment, each of the 18 CF participants will be admitted to the Inpatient Clinical Research Center (CRC) Unit for 48 hours. The subjects will be enrolled sequentially into one of 2 cohorts of 9 patients each in a 2:1 fashion (active drug: placebo): initially a low-dose NO cohort (6 active: 3 placebo) followed by a high-dose NO cohort (6 active: 3 placebo). The NO or placebo (nitrogen) will be administered via nasal cannula over a 44 hour period. The patient, investigator, study coordinators and respiratory therapists will not know which drug (NO or placebo) the patient is receiving. The lead study RT will be unblinded if it is required.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
The Children's Hospital | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Churee Pardee, RN 303-861-6162 | |
Principal Investigator: Scott Sagel, MD |
Principal Investigator: | Scott Sagel, MD | The Children's Hospital |
Responsible Party: | INO Therapeutics ( Rob Small ) |
Study ID Numbers: | INOT 50 |
Study First Received: | December 6, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00570349 |
Health Authority: | United States: Food and Drug Administration |
Inhaled Nitric oxide Cystic Fibrosis |
Nitric Oxide Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Protective Agents |
Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Peripheral Nervous System Agents Bronchodilator Agents |